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January 1, 2019Comments OffHeadache Drug Trial | Headache Relief | Headache Shampoo | Headache Study | Headache Therapy
Surgical Treatment of Peri-implantitis Using a Bone Substitute With or Without a Resorbable Collagen Membrane

The purpose of the study is to compare treatment outcomes of peri-implantitis defects when using a defect fill substitute (InterOss Collagen), against the treatment outcome when placing the same defect fill substitute with a resorbable collagen membrane (InterCollagen Guide). There is no current literature to suggest that placing a collagen membrane over a bone grafting material in an infrabony defect of more than 270 degrees is more effective than placing the bone graft material alone. The present study will help in understanding if such defects require an additional placement of a collagen membrane which could increase the cost of the procedure for the practitioner and the patient.

The study will be conducted at the University of Pittsburgh School of Dental Medicine Graduate Periodontics Department. A detailed description of research activities during each patient visit is provided below.

Screening Visit (V0):

Prior to starting any of the procedures, the subject will complete the informed consent interview. Patients will be screened to assess for inclusion in the study. Vitals (blood pressure and heart rate) will be measured and medical history will be discussed. Limited field of view (FOV) cone beam computed tomography (CBCT) scan will be taken and examined prior to the study to determine the presence of a 270 degree circumferential boney defect for inclusion in the study. Probing pocket depths (PPD), plaque sites, mobility and bleeding on probing (BOP) are clinical measurements that will be completed. A periapical (PA) radiograph will be taken to confirm a crater like defect >=3mm for inclusion in the study. Clinical photographs will be taken of the teeth and inside of the mouth. The visit will take approximately 1.5 hours. All procedures will be performed by the faculty and Periodontics graduate resident.

Pre-surgical phase (V1):

If the patient is eligible and willing to participate in the study following the screening visit, they will return for V1. Their medical history will be reviewed, blood pressure and heart rate will be measured. Any adverse events from the previous visit will be assessed. The prosthetic superstructures (implant crowns) will be removed followed by placement of cover screws. PPD will be measured twice (with and without the implant crown). Bleeding on Probing (BOP), mobility, and plaque sites will be recorded. Clinical photographs will be taken. Prosthesis superstructure will be scanned with a Trios digital scanner to be able to study the emergence profile. Generalized supragingival debridement will be performed. Patients will be informed that newly fabricated crowns might be needed after the treatment as part of the study. During this visit, patients will be also re-instructed and emphasized on maintaining proper at-home oral hygiene measures with a soft-bristled toothbrush for minimizing trauma to marginal soft tissues. The visit will take approximately 2 hours. All procedures will be performed by the faculty and Periodontics graduate resident.

Surgical treatment procedures (V2) After 4 to 6 weeks, the patient will undergo regenerative surgical procedure. Their medical history will be reviewed, blood pressure and heart rate will be measured. Any adverse events since the previous visit will be assessed. The Study individuals will receive a local anesthetic as needed by the surgeon. Intra-sulcular, and if necessary, vertical releasing incisions will be made. Soft tissue flaps will be elevated at buccal and lingual aspects providing adequate access. Granulation tissue and mineralized deposits at implants will be removed using titanium curettes. The implant surfaces will be decontaminated with airflow. Once the surgical site was debrided, clinical intra-surgical measurements will be made. The measurement of peri-implant defect depth will be made clinically intra-surgically. Defects will be measured using a prefabricated acrylic stent stabilized on adjacent teeth. The depth will be measured from the marked area of the stent to the deepest point of the defect. This will be termed the clinical vertical defect fill (DF), and assessed at each implant site (buccal, lingual/palatal, mesial, distal) as follows: DF = (Measurement at the surgical treatment) – (Measurement at re-entry procedure). The defect resolution (DR) on the other hand will be measured as the percentage of the defect that was filled with bone at the follow up compared to the original defect depth.

Thereafter, study individuals will be randomized to control or test groups using the SPSS randomization method (SPSS PASW 23.0 statistical software package, SPSS Inc., Armonk, NY, USA). Depending on the randomization, one of the following therapies was used: (a) (control group); bone grafting alone (InterOss Collagen) will be placed. (b) (test group); the intraosseous component will be filled with bone grafting (InterOss Collagen) and covered with a resorbable collagen membrane (InterCollagen Guide). InterOss Collagen is an FDA cleared for use in guided bone regenerative procedures. InterOss Collagen is a bovine derived anorganic hydroxyapatite collagen composite composed of 90% bovine granules and 10% collagen fibers molded in a block form. InterCollagen Guide is an FDA cleared porcine derived resorbable collagen membrane intended for periodontal and dental surgeries. In both groups, if needed, a periosteal releasing incision will be made to allow complete coverage of the wound area. In both study groups, surgical soft tissue flaps will be sutured with interrupted sutures without tissue tension using 4/0 or 5/0 PGA providing full wound closure. Clinical photographs will be taken again, and surgical video may be recorded when possible. All study individuals will receive postoperative antibiotics and prescribed post-operative pain relievers, as well as care instructions.

The postoperative medications may include:

Amoxicillin 500 mg 3 x 7 days

  • Clindamycin 300 mg 4 x 7 days Ibuprofen 600 mg PRN Chlorhexidine 0.12% rinse 2 x 2 weeks Instructions not to wear any removable prosthesis during the healing phase
  • Administer if drug allergy to Amoxicillin The visit will take approximately 2.5-3 hours. All procedures will be performed by the faculty and Periodontics graduate resident.

    4 weeks post op (V3) After 4 weeks (± 2 days), the patient will return for follow-up. Any changes to their medical history will be reviewed, blood pressure and heart rate will be measured. Any adverse events since the previous visit will be assessed. Sutures will be removed. Clinical photographs will be taken again. Subject’s pain assessment forms will be collected. The visit will take approximately 0.5-1 hours. All procedures will be performed by the faculty and Periodontics graduate resident.

Re-entry procedure and replacement of superstructures (healing abutment) (V4) After 4 months of uninterrupted healing, patients will return for the re-entry procedure. Any changes to their medical history will be reviewed, blood pressure and heart rate will be measured. Any adverse events since the previous visit will be assessed. A standardized PA radiograph will be taken at this visit. Intrasulcular incision will be performed on the adjacent teeth and midcrestal incision at the implant location. Full thickness flap will be elevated, and the same defect measurements taken during the surgical procedures will be performed to obtain clinical changes in peri-implant bone levels. Where the defect fill will be measured using an acrylic stent as the difference in millimeters between the initial measurements taken at baseline and the depth of defect present at follow up. Implant cover screws will be replaced by appropriate healing abutments, followed by single interrupted sutures for re-adaptation of the flap. Clinical photographs will be taken again, and surgical video may be recorded. Finally, a periodontal maintenance will be performed. The visit will take approximately 2 hours. All procedures will be performed by the faculty and Periodontics graduate resident. During this period, if needed new crowns will be designed, fabricated, and delivered to all patients and for all treated implants.

Post op after stage 2. (V5) Approximately 2 weeks after V4, subjects will return for V5. Any changes to their medical history will be reviewed, blood pressure and heart rate will be measured. Any adverse events since the previous visit will be assessed. Subject pain assessment form will be completed. Sutures will be removed. Digital impression will be taken with the Trios hand-held scanner, and patient will be referred to receive a new crown, if needed. If no new crown is needed, the old crown will be replaced at the next visit. Clinical photographs will be taken again. The visit will take approximately 1-2 hours. All procedures will be performed by the faculty and Periodontics graduate resident.

Crown placement/replacement (V6) Approximately 1 month after V5, the subjects will return for the Implant Crown replacement. Any changes to their medical history will be reviewed, blood pressure and heart rate will be measured. Any adverse events since the previous visit will be assessed. The old crown or the new crown will be placed in the treated area. A radiograph may be taken to assist in placement. The visit will take approximately 1- 2 hours. All procedures will be performed by the faculty and Periodontics graduate resident.

8 months visit (V7) For V7, subjects will return at approximately 8-months post-op. Any changes to their medical history will be reviewed, blood pressure and heart rate will be measured. Any adverse events since the previous visit will be assessed. Probing pocket depth (PPD), BOP, plaque, and mobility measurement will be recorded. Radiographic measurements (bone fill) will be obtained as performed at the pre-surgical visit (time point 0). Dental prophylaxis and periodontal maintenance will be performed. Clinical photographs will be taken again. The visit will take approximately 0.5-1 hours. All procedures will be performed by the faculty and Periodontics graduate resident.

12 months visit (V8) The final visit will occur at 12 months post-op. Any changes to subject’s medical history will be reviewed, blood pressure and heart rate will be measured. Any adverse events since the previous visit will be assessed. Probing pocket depth (PPD), BOP, mobility and plaque measurements will be taken as in previous visits. Radiographic measurements (bone fill) will be obtained as performed at the pre-surgical visit (time point 0) using a standardized PA radiograph. Periodontal maintenance will be performed. Clinical photographs will be taken again. The visit will take approximately 0.5-1 hours. All procedures will be performed by the faculty and Periodontics graduate resident.

Clinical measurements at baseline, 4- 10 months after surgery

  • The following baseline procedures will be performed; (a) Intra-oral photographs and intra-oral radiographs of the implant sites; (b) clinical recording of full mouth plaque scores (FMPS) (presence of dental plaque along the peri-implant mucosal margin (gingival margin at teeth) was expressed as a percentage of examined sites within each subject including four sites per tooth and implant, (c) clinical recording of local plaque score (LPS) (presence of dental plaque along the mucosal margin at four sites of each treated implant and expressed as a percentage of implant sites within each subject), (d) clinical recording of probing pocket depths (PPD) (at all teeth, and the specific implant in the study (six sites; implant/tooth) to the nearest millimeter with a periodontal probe (e) clinical recording of full mouth bleeding score expressed as percentage of assessed surfaces with bleeding on probing (f) clinical recording of recession at the peri-implant mucosal margin (buccal/lingual- palatal) relative to a fixed reference point on implants and (g), clinical recording of presence/absence of suppuration (SUP) at the implant (6 sites/implant).
  • Peri-implant defect depth will be made clinically intra-surgically. Defects will be measured using a prefabricated acrylic stent stabilized on adjacent teeth. The depth will be measured from the marked area of the stent to the deepest point of the defect. This will be termed the clinical vertical defect fill (DF), and assessed at each implant site (buccal, lingual/palatal, mesial, distal) as follows: DF = (Measurement at the surgical treatment) – (Measurement at re-entry procedure). The defect resolution (DR) will be measured as the percentage of the defect that was filled with bone at the follow up compared to the original defect depth.
  • MBL will be calculated based on standardized radiographs using registered bite-block with a Rinn (Dentsply Rinn, Elgin, IL, USA) film holder and expressed as the distance from the implant shoulder to the most coronal bone-to-implant contact (BIC) on the mesial and distal side of the implant. The mean values will be calculated for each implant. In the case that the bone levels around the study implants are hidden or difficult to read, new radiographs will be taken. Peri-implant marginal bone levels will be measured using the ImageJ software. The software will be calibrated for every single image using the known implant length or the length of the implant collar. Measurements of the mesial and distal bone crest level adjacent to each implant will be rounded to the nearest 0.1 mm. Implants with bone up to the coronal margin of the implant collar will be given a value of zero. Mesial and distal measurements of each implant are averaged, and a mean calculated at patient level and then at group level. Implant failure: It will be defined as implant mobility assessed from force applied with two hand instrument), pain, or neuropathy. Composite definition of successful treatment outcome: A composite therapeutic endpoint composed of no evidence of BOP or evidence of BOP grade 1 and with no suppuration at any of four assessed sites per implant PPD ≤5 mm, and with ≥1.0 mm defect fill will be used to define a successful treatment outcome. Thickness of soft tissues will be measured with a 1.0-mm marked periodontal probe on the top of bone crest in the center of the implant. This will ensure direct visibility of mucosal thickness during measurement.

Source: View full study details on ClinicalTrials.gov

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

January 27, 2023Comments OffClinicalTrials.gov | Dental Studies | Oncology Clinical Trials | US National Library of Medicine
Comparison of Clinical Outcomes Between GentleWave® and Biolase®

This is a single-blinded, block randomized control trial study, 120 participants will be recruited with 40 participants randomly allocated to the GWS treatment group, 40 randomly allocated to the WL treatment group, and 40 randomly allocated to the control group (CG) receiving PUI treatment (Fig 1). Participants will be selected consecutively based on our inclusion and exclusion criteria. Participants will be recruited and treated at a single site, the University of North Carolina at Chapel Hill Adams School of Dentistry (UNC-CH ASoD) Endodontic Clinic.

There will be an initial baseline/screening appointment that may or may not develop into the first treatment appointment, followed by a potential second treatment appointment to complete treatment as per current treatment protocols in the Endodontic Clinic. Then participants will be followed for 12 months to evaluate clinical and radiographic healing of periapical lesions. Investigators will also assess clinician and patient opinion of the treatment modality employed in addition to calculation of a cost-time ratio.

Patients will receive endodontic treatment for endodontic infections with potential improvements in procedure outcomes, number of visits, and patient intraprocedural comfort. There are the same risks for any root canal procedure that can include intraprocedural or postoperative sensitivity, inflammation infection, numbness, intraprocedural or postoperative pain, reaction to materials used, sodium hypochlorite extrusion, instrument fracture, or perforation. The investigators will manage these risks through execution of proper instrument usage and adherence to clinical protocols.

The investigators do not anticipate difficulty in **RECRUITING NOW** the required number of study participants based on the number of patients seen annually. Each week, approximately fifty patients are seen in the ASoD clinic for endodontic treatment, of which at least 50% meet the inclusion criteria for our study. There are nine trained residents in endodontics who carry out approximately five-six treatments per week. Nevertheless, all subjects are free to withdraw from participation at any time, for any reason, specified or unspecified, and without prejudice. A subject may leave at any time if the subject and/or investigator feel that it is not in the subject’s best interest to continue.

Study participants will be consecutively recruited from the Endodontic Clinic at UNC-CH ASoD. Specifically, they will be patients seeking endodontic treatment at ASoD. At the consult/treatment appointment, screened potential participants meeting the inclusion/exclusion criteria will be informed of the study and potential treatment modalities by a member of the research team who is not the treating clinician. Patients will be given adequate time to decide if they would like to participate. Once a participant consents/assents to participation in the study, they will be randomly allocated to either the control group, GentleWave treatment group, or the Waterlase treatment group in a block randomized manner. Once a participant is assigned a treatment, the treatment will take place at the same appointment as the baseline/screening appointment or scheduled for another appointment. Treatment will be completed in one or possibly two appointments. Thereafter, the patient will be scheduled for a 12-month follow up visit to evaluate clinical and radiographic healing of the periapical lesion and tooth. This follow-up appointment, depending on the amount of treatment appointments required to complete treatment, may be the second, third, or fourth appointment.

Patients who agree to participate in the study will be randomized to either the GWS, WL, or control groups. As previously mentioned, each treatment group consists of 40 patients. Eight blocks of fifteen treatments (five of each treatment type) will be used. Once a patient consents/assents to participation in the study, a third party will be contacted who has access to the block randomization and they will inform the research team which treatment the patient is to undergo. This will help with organization of the treatment room with the appropriate equipment. Patient details and treatment allocation will be recorded on a password-protected Excel spreadsheet.

Source: View full study details on ClinicalTrials.gov

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

January 26, 2023Comments OffClinicalTrials.gov | Dental Studies | Oncology Clinical Trials | US National Library of Medicine
Antiseptic Effects on the Dental Implant Internal Surface Microbiome

Clinical Background

Peri-implantitis/mucositis is bone loss/tissue inflammation around a dental implant. This is caused by bacterial biofilm at the interface between the implant and bone/tissue. The source of bacteria comes from the internal surface of the implant, and leaks through the implant/abutment interface. After the dental implant is placed in bone, bacteria from the saliva and blood within the internal surface of the implant leak out. The body reacts to this bacterial exposure with inflammation, resulting in bone loss around the implant/abutment interface.

Warfighters are exposed to situations in which the risk of dental trauma is elevated compared with the civilian population. This is particularly problematic for the military because poor dentition can disqualify Soldiers from service. Proper mastication is crucial to readiness. The number of implants inserted annually has risen by more than 10-fold since the 1980s. There are now over 700,000 implants inserted annually (Battle-Siatita et al., 2009). Unfortunately, implant-associated infections such as peri-implant mucositis and peri-implantitis are common, affecting approximately 63% and 19% of recipients, respectively (Atieh et al., 2013). Though, it should be noted that others have suggested the number could be as high as 80% (Podhorsky et al., 2016). Because these conditions negatively impact implant success rates, preventive measures aimed at reducing the risk of these diseases have tremendous potential to transform dental care and improve readiness.

Previous studies have found evidence suggesting that microbial profiles differ between healthy implants and those exhibiting peri-implantitis (Schwarz et al., 2018). For example, at least 19 species such as Porphyromonas gingivalis, Pseudomonas aeruginosa, and Staphylococcus aureus are more abundant on affected implants (Schwarz et al., 2018). Thus, it may be important to not only control total bacterial load but also to ensure that any intervention produces a favorable change in the implant-associated microbial profile.

A recent systematic review determined that there is strong evidence to support the use of chlorhexidine rinses after implant surgery (Solderer et al., 2019). The positive effects of chlorhexidine rinses on implant success appear to be the result of the impact of chlorhexidine on reducing biofilm-related complications (Daubert & Weinstein, 2019; Solderer et al., 2019). While the effects of chlorhexidine rinses have been well described, there has been little investigation into the potential impact of disinfectants placed within the internal cavity of dental implants. A PubMed search for “dental implant internal disinfectant” returned only 15 articles in English. Of the articles considering the implant’s internal cavity, 4 were in vitro studies (Besimo et al., 1999; Duarte et al., 2006; Podhorsky, Biscoping, et al., 2016; Podhorsky, Putzier, et al., 2016). All 4 studies strongly support the use of chlorhexidine gel in the internal cavity of implants. Another 4 studies, examined the ability of chlorhexidine gel placed within the dental implant internal cavity to affect total bacterial load between 3 and 6 months after surgery (Carinci et al., 2019; D’Ercole et al., 2009; Ghannad et al., 2015; Paolantonio et al., 2008). All 4 studies reported that intervention resulted in decreased bacterial load. Using PCR specific to only 6 bacterial taxa or using culturing methods, two of these manuscripts reported no change in microbial profiles (Ghannad et al., 2015; Paolantonio et al., 2008). However, one paper reported that the gel altered microbial profiles (D’Ercole et al., 2009). Given that the oral microbiome consists of hundreds of bacterial species, these previous studies have inadequately examined the impact of chlorhexidine gel on microbial profiles. Moreover, there have been no studies examining the use of alternative disinfectants. Another common disinfectant used intraorally is hydrogen peroxide. This disinfectant is used to treat periodontitis and for teeth whitening. We propose to analyze the effect of this second material on total bacterial load and the microbial profile within the internal aspect of the dental implant.

The rate and degree of peri-implantitis/mucositis, bone/tissue loss, and inflammation, coupled with the determination of bacterial load and microbiome composition will allow for the determination of the value of hydrogen peroxide or chlorhexidine placed within the dental implant internal cavity.

Problem/Question

Certain bacteria from the saliva and blood that get inside the implant are more pathogenic (disease causing) than others. In the dental field, there are topcial agents regularly used as mouth rinses to decrease this bacterial load, and create a healthier bacterial environment with less pathogenic potential.

Because of the nature of the job, warfighters are at increased risk of oral trauma compared with the civilian population. Corrective procedures following trauma often include the insertion of dental implants. The number of annual dental implant insertions has risen more than 10-fold since the 1980s, and now sits at more than 700,000 per year (Battle-Siatita et al., 2009). Unfortunately, dental implant failure rates are high. This has high costs because of the need for additional surgeries, reduced quality of care, and reduced warfighter readiness. The implant-associated microbiome has been implicated as a key effector in implant failure and bone loss. In this study, we aim to evaluate methods that reduce or alter the implant-associated microbiome and therefore improve implant success rates.

Source: View full study details on ClinicalTrials.gov

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

January 21, 2023Comments OffClinicalTrials.gov | Dental Studies | Oncology Clinical Trials | US National Library of Medicine
Dental Appliance to Treat SDB in Children

The purpose of this study is to evaluate the safety and efficacy of an mouthguard (Vivos Grow/Vivos Way) to reduce sleep-disordered breathing (SDB) in children, including:

snoring, mild to moderate obstructive sleep apnea (OSA), and upper airway resistance syndrome (UARS) in children.

The subjects enrolled in this study will be using the Vivos Grow/Vivos Way to correct orthodontic issues and must also present with signs of SDB.

The study will recruit pediatric subjects who have already elected to utilize the study device for their orthodontic treatment; if they meet the inclusion and exclusion criteria they can be included in the study.

Source: View full study details on ClinicalTrials.gov

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

December 23, 2022Comments OffClinicalTrials.gov | Dental Studies | Oncology Clinical Trials | US National Library of Medicine
Implant Primary Stability and Ridge Dimensional Changes Utilizing the Osseodensification Protocol

Device: OsseoDensification (OD) protocol

Osseodensification is a drilling process by which bone is being compacted and auto-grafted in an outwardly expanding direction from the osteotomy. When the osseodensification drills are being rotated in a reversed, non-cutting direction a strong and dense layer of bone is formed along the walls and base of the osteotomy.

Source: View full study details on ClinicalTrials.gov

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

November 22, 2022Comments OffClinicalTrials.gov | Dental Studies | Oncology Clinical Trials | US National Library of Medicine
REMBRANDT: REcovery of the MicroBiome fRom Antibiotics for Dental implanTs

Clostridioides difficile infection (CDI) is one of the most common causes of healthcare-associated infectious diarrhea and results in significant morbidity and mortality. CDI occurs when the native gut microbiome is disrupted, most often following antimicrobial therapy, and the consequent dysbiosis results in a decrease in microbial diversity, changes in abundance of certain bacterial taxa, and loss of colonization resistance against C. difficile. Restoration of a “functionally intact” gut microbiome is critical to clearing C. difficile, and inadequate restoration can lead to recurrent CDI. The recovery of the gut microbiome from dysbiosis is poorly understood, and factors associated with having and re-gaining a providing colonization resistance against C. difficile are not well known. While animal reservoirs can serve as potential sources of pathogenic bacteria, studies by the candidate and other investigators found that pet ownership protects against colonization and re-infection with C. difficile. Moreover, microbiota are shared between pets and their owners, and the microbiomes of pets contain bacterial taxa that provide colonization resistance against C. difficile. Based on these data, the proposed research will 1) test the hypothesis that the observed protective effects of pet ownership are due to sharing of microbiota that provide colonization resistance against C. difficile between pets and owners; 2) determine whether pet contact mitigates antimicrobial-associated disruption of the gut microbiome and enhances its recovery; and 3) assess whether pet contact decreases the likelihood of colonization and infection with C. difficile following antimicrobial therapy. This will be accomplished though longitudinal sampling of the gut microbiome within the patient/pet unit among patients older than 50 years (i.e., at greatest risk of CDI) receiving prophylactic antimicrobials for non-enteric indications (dental implants).

The study will further define epidemiologic and pathophysiologic characteristics of CDI that could enhance therapeutic options for this disease. The underlying premise that animals are a source of protective microbiota rather than a reservoir of C. difficile represents a paradigm shift in CDI epidemiology that may identify animal contact as a novel microbiome-based form of therapy.

Source: View full study details on ClinicalTrials.gov

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

November 22, 2022Comments OffClinicalTrials.gov | Dental Studies | Oncology Clinical Trials | US National Library of Medicine
Pain and Activity Levels After Orthodontic Separators

Acute pain or discomfort during orthodontic treatment is commonly reported. A study done in 2002 found that 87% of patients experienced pain after orthodontic visits. Additionally, “feeling pain” has been identified as the primary treatment concern for many patients prior to orthodontic treatment. More so, it can negatively affect patient compliance and attitude toward treatment.

Numerous studies have shown that pain varies in intensity and duration among orthodontic patients. The placement of orthodontic separators is a standard procedure to facilitate placement of orthodontic bands by creating a small amount of space between posterior teeth. Separator placement reliably produces acute discomfort to patients. Pain generated from orthodontic separator placement originates in the periodontal ligament (PDL) as compression forces are applied to the PDL unequally to open a small space (less than 0.5 mm) between the teeth. This compression triggers sterile necrosis or hyalinization in some areas of the PDL, leading to acute pain. The course of pain generated from orthodontic separators typically begins 4 hours after placement, reaching highest pain intensity approximately 24 hours after placement, and continuing to decrease in intensity until returning to pre-placement baseline after seven days.

Variation in reported pain intensity across orthodontic patients is of interest to any practitioner who desires to improve patient outcomes. In an attempt to enhance the orthodontist ability to understand pain and its predicting factors, researchers have examined pain from orthodontic treatment relative to patient demographics, personality traits, psychological factors, perceived need and attitude toward treatment, among others. Okeson asserts that pain is not directly related to the extent of tissue injury. Noxious stimuli originating in peripheral neurons (such is the case with separators) are subject to modulation at multiple levels through a complex central inhibitory system, where many other factors participate in decreasing or increasing the pain experience. Hence, an individual’s emotional state, pain expectation and perception of control, as well as activities or distractions that will differ brain attention (Gate Control) can significantly influence the pain experience. Perceived stress, or the degree to which situations in an individual’s life exceed their ability to cope, could be a good predictor of experienced pain. The Perceived Stress Scale is the most widely used screening form to evaluate perceived stress and asks subjects to recall the frequency of feeling overloaded and overwhelmed in the past month.

Recently, more attention has been given to the role of physical activity (PA) in reducing pain in patients that undergo orthodontic treatment. Physical activity has been shown to be an effective mediator of acute pain tolerance and pain sensitivity, an effect known as Exercise Induced Hypoalgesia (EIH). One study reported that a 1-mile run decreased pain intensity evoked from a weight being placed on the index finger. A similar decrease in pain response to pressure applied to the finger was found in subjects in another study who performed 30 minutes of aerobic exercise. It has also been demonstrated that exercise increased dental pain thresholds in response to electrical stimulation of the pulp. The exact mechanism involved in EIH remains elusive. Still, several pathways have been implicated including activation of the endogenous opioid pathway, increased Adrenocorticotropic Hormone release, and a conditioned pain the pain perceived in another area of the body.

Researchers have demonstrated that higher self-reported physical activity reduced the pain levels generated by placement of orthodontic separators when compared to patients with low physical activity. Self-reported measurements of physical activity carry limitations. The Physical Activity Questionnaire (PAQ) used in previous studies have demonstrated an only moderate correlation with direct activity observation (r=0.45), and with an activity monitoring device (r=0.57). The PAQ asks participants to report pain in the last seven days, and if given before treatment was performed, provides no data on physical activity during the week when subjects are experiencing pain. To further explore the correlation between physical activity and acute pain during orthodontic treatment, a more reliable measure of physical activity is warranted.

Actigraphy sensors provide an objective measure of physical activity. Actigraphy sensors include pedometers, which count steps over a defined time interval, and accelerometers, which measure acceleration in “activity counts” that are then extrapolated to the Metabolic Equivalent of Task (METS) to measure energy expenditure. No other paper has evaluated the effect of physical activity measured with pedometers on acute pain following separators placement during orthodontic treatment. Because not all patients experience pain at the same level, it would be beneficial for clinicians to identify which patients are likely to experience more intense pain before beginning treatment. To this end, the purpose of this study is to test the effect of physical activity measured by pedometer on acute pain produced by the placement of separators.

Source: View full study details on ClinicalTrials.gov

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

November 15, 2022Comments OffClinicalTrials.gov | Dental Studies | Oncology Clinical Trials | US National Library of Medicine
A Study of Tooth Erosion in People With Esophagogastric Cancer
Experimental: Survey and Dental imaging

Patients have completed the intervention once completing the survey and undergoing dental imaging.

Other: Survey

This is a 15-item questionnaire. The questionnaire asks subjects to quantify, during a specified duration of time, the number of times they have consumed or completed a task (ex. alcohol intake, cigarette use, and teeth brushing frequency). Additionally, the questionnaire further asks subjects to quantify their GERD symptoms and risk factors prior to diagnosis. All study procedures will be completed in one visit as part of a standard-of-care clinic visit.

Other: MouthWatch intra-oral camera

Pictures will be taken in 13 key regions.

Source: View full study details on ClinicalTrials.gov

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

November 11, 2022Comments OffClinicalTrials.gov | Dental Studies | Oncology Clinical Trials | US National Library of Medicine
Imaging-based Assessment of Oral Biofilm and Gingival Health

Participants will be asked whether they fulfill study inclusion/exclusion criteria. If recruited, they will be asked to sign the informed consent form. No professional dental cleaning will be performed before or during the trial in order to avoid the influence this would have on the data gathered. Participants will be randomly assigned to use one of the oral care products, which are all OTC products and will be used in the intended manner.

For toothpastes, participants will be asked to brush twice daily for the study duration with one of the following test dental gels: LivFresh Dental Gel (Livionex, Los Gatos, CA); LivFree Dental Gel (Los Gatos, CA); AIM (Church and Dwight, Ewing, NJ); Parodontax (GSK, Philadelphia, PA); Crest Prohealth (P&G, Cincinnati, OH); and Colgate Total (Colgate-Palmolive, New York, NY). A standard Oral B ProFlexR toothbrush will be provided to each volunteer, and participants will be trained in standard sulcular brushing technique. Participants will brush participants’ teeth two hours prior to each visit and refrain from eating from that time onwards until after participants’ visit. Participants allocated to mouthrinse use will continue with participants’ usual oral hygiene protocol; additionally, the participants will be asked to rinse twice daily with 1 capful for 1 minute with the Lumineux Mouthrinse (Lumineux, Beverley Hills, CA) directly after brushing participants’ teeth. Plaque levels (P.I.), gingival inflammation, and sulcus bleeding (mSBI) will be recorded.

A standardized periodontal probe will be used to measure pockets. Saliva production will be measured by asking participants to expectorate into a graduated cylinder for 5 minutes. Saliva will not be stored or analyzed in any way.

Volunteers will be photographed and evaluated on all study dates by the same blinded, pre-calibrated investigator. Photographs will be recorded using a standard dental intraoral camera, which only records intraoral images, thus automatically rendering the images unidentifiable with regard to each subject’s facial appearance. These photos will not show the subject’s face but will focus on the subject’s mouth. Participants will be asked whether participants fulfill study inclusion/exclusion criteria inclusion/exclusion criteria.

Study duration will be 7 days or 1, 3, or 6 months. Each visit will last approximately 30 minutes. Initially, study duration will be 7 days as the investigators develop the imaging- based techniques. Once the techniques are finalized, study duration will be incrementally increased to 1 month, then 3 months, then 6 months to validate and refine the imaging-based techniques.

Source: View full study details on ClinicalTrials.gov

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

November 4, 2022Comments OffClinicalTrials.gov | Dental Studies | Oncology Clinical Trials | US National Library of Medicine
Novel Dental Gel as an Adjunct to Scaling and Root Planing

The current standard of care in treating periodontitis is scaling and root planing (ScRP). ScRP is the instrumentation of the crown and root surfaces of teeth to remove plaque, tartar, and stains, as well as, the removal of cementum or surface dentin that is rough, impregnated with calculus or contaminated with toxins and/or microorganisms. This procedure is performed because the patient is at the stage of their disease where the bacterial load has accumulated subgingival and their toothbrush or interdental devices is no longer efficacious. As the etiology of the disease is removed, it relieves the biological burden and allows the body to resolve the inflammation. To prevent re-initiation of the disease, oral hygiene and periodontal maintenance therapy is key to periodontal health and stability. Formation of plaque begins with the formation of a pellicle which occurs within seconds after a tooth surface is cleaned. Within minutes, weak adhesion of bacteria to pellicle is formed. If bacteria is not removed or disturbed within 24-48 hours, primary colonizers such as Streptococcus and Actinomyces sp are firmly attached and provide new receptors for attachment of other bacteria. Toothbrushing twice daily and interdental cleaning daily limits the ability for over accumulation of biomass thus preventing the initiation of chronic inflammatory process.

The benefits of optimal at-home plaque control have greatly contributed to maintaining a functional dentition throughout life, decrease risk of attachment loss, benefits in appearance and breath freshness, and prevention in expensive dental care. Despite this knowledge, 69% American adults brush their teeth twice daily and only 31.6% of Americans adults use interdental devices. And of those who do perform mechanical debridement their efficacy in plaque removal is in question. Not to mention, the elderly with cognitive and physical conditions which may inhibit adequate oral hygiene practices such as advanced dementia and severe arthritis. Studies have demonstrated high prevalence rates of caries, poor oral hygiene, gingival inflammation, dry mouth, bleeding gums, and periodontal disease among nursing home elders. Because of this, the quest to attain plaque control more easily has been researched through better toothbrush designs and new dentrifice formulations. Over the counter dentifrice formulations typically include flavorings, chelators, colors, preservatives, foaming agents, abrasives, and detergents. Some of these common ingredients have the potential to be too abrasive and remove tooth structure, cause sensitivity or allergic reactions, and some have been reported to spread in the blood and different organ systems. Without knowing the long-term effects of these findings, manufacturers are avoiding some of these ingredients. Recent studies have shown a dental gel with activated edathamil (2.6 % Livionex) has demonstrated reduced plaque accumulation and improved gingival health while minimizing the side effects experienced with over-the-counter dentifrices. Its anti-plaque ability is explained by its capability to bind to cations such as calcium and iron which are essential for bacterial adherence to tooth structures. A dental gel that is attainable for the public and have the capabilities of minimizing plaque accumulation shows promise to individuals that struggle with plaque control and recurrence of periodontal disease.

The overall aim of this randomized, double-blind, active-control safety and efficacy study will be to evaluate the adjunctive therapeutic effect of using LDG as a home care product in reducing probing pocket depth (PD) beyond the effect achieved by the current standard of care with SRP in stage II and III periodontitis patients.

Source: View full study details on ClinicalTrials.gov

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

November 4, 2022Comments OffClinicalTrials.gov | Dental Studies | Oncology Clinical Trials | US National Library of Medicine