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Periodontitis clinical trials

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NCT ID: NCT06131021 Recruiting - Periodontitis Clinical Trials

Shaping the Indications for Periodontal Adjunctive Antibiotics in Dental Practice

PAAS
Start date: April 25, 2024
Phase: Phase 3
Study type: Interventional

Periodontitis is a bacterial inflammatory disease and antibiotic use is being empirically used as part of its treatment. However, a clinical practice guideline on periodontal treatment adjuncts published in 2015 identified weak evidence on the use of systemic antibiotics and large heterogeneity across small scale studies, suggesting that larger pragmatic clinical trials would benefit clinical decision making. This will be a prospective, randomized, placebo-controlled trial, stratified by practice and practitioner. The study will investigate the effectiveness of adjunctive antibiotics as adjunct to scaling and root planing (SRP) compared to SRP with placebo for the treatment of generalized stage II-III, grades A-C periodontitis in approximately 544 patient participants from about 34 National Dental PBRN practices. Periodontal data will be collected at baseline, re-evaluation (6 weeks), and final (12 months) study visits. Changes in periodontal clinical and patient-reported outcomes will be assessed to determine the effectiveness of SRP plus adjunctive systemic Amoxicillin / Metronidazole antibiotics (AMXM) versus SRP with Placebo.

NCT ID: NCT06129097 Recruiting - Clinical trials for Periodontal Diseases

Thyme Honey Mouthwash in Management of Periodontitis in Renal Patients

Start date: January 1, 2024
Phase: N/A
Study type: Interventional

There is a known correlation between oral health and systemic disease. Particularly significant evidences associate periodontal bacteria and tooth loss to systemic disorders and specifically to cardiovascular disease, such as high BP. Furthermore, a correlation between periodontal disease and hypertension has been recently reported ESRD and the medications used by those patients create complications in a variety of systems and organs, which frequently worsens or causes new pathologies in the oral cavity, such as caries, periodontal disease, and different mucosal lesions. Therefore, the current trial was set up to first evaluate the effect of thyme honey oral rinse in ESRD patients with periodontitis using CAL as a primary objective, and to evaluate the clinical effectiveness of thyme honey oral rinse in ESRD patients with periodontitis on bleeding on probing (BOP) and plaque index, and salivary NO levels as secondary objectives.

NCT ID: NCT06123000 Recruiting - Periodontitis Clinical Trials

Modified Widman Flap vs Fibre Retention Osseous Resective Surgery

Start date: October 21, 2023
Phase: N/A
Study type: Interventional

The treatment of periodontitis should be carried out in an incremental manner, first by achieving adequate patient's oral hygiene practices and risk factor control during the first step of therapy and then, during the second step of therapy, by professional elimination (reduction) of supra and subgingival biofilm and calculus. If the endpoints of therapy (no periodontal pockets >4 mm with bleeding on probing, BoP, or deep pockets ≥5 mm) have not been achieved, the third step of therapy should be implemented. In fact, residual pockets following step 1 and 2 of periodontal treatment are associated with increased risk of periodontal disease progression in the long-term as reported by Claffey & Egelberg in1995. Residual probing depth (PPD) ≥5 mm after active therapy is a risk factor for disease progression and tooth loss during supportive periodontal therapy (SPT), suggesting that additional treatment of residual pockets is strongly recommended. The third step of treatment includes the following interventions: repeated subgingival instrumentation, access flap periodontal surgery, resective periodontal surgery, regenerative periodontal surgery. In case of residual pockets associated with shallow-moderate infrabony defects at posterior teeth, where both regenerative therapy and non-surgical re-instrumentation are usually not indicated, access flap procedures (i.e., the Modified Widman Flap, MWF) and the Osseous Resective Surgery (ORS) are considered two of the most viable options. The value of these surgical techniques has been tested over the years by different clinical trials, and the choice of a surgical approach still relies mainly on the decision-making process of the surgeon, since the long-term outcomes of the different periodontal surgical procedures are similar, as highlighted by a recent systematic review. Nevertheless, one the main criticism that have been moved against ORS, lies on the fact that the side effects (i.e., gingival recessions) seem to be more severe for ORS surgery, when compared with MWF. In the early 2000s, Carnevale proposed the Fibre Retention Osseous Resective Surgery (FibReORS), an approach that leads to a more conservative bone resection to eliminate infrabony defects and establish a positive bony architecture than the conventional ORS. Indeed, this one, based on the histological findings by Gargiulo et al. (1961), uses the level of the connective tissue attachment - rather than the bottom of the osseous defect - as the reference to apply the principles of ORS. Two randomized clinical trials demonstrated that FibReORS is similarly effective as ORS for PPD reduction with less final gingival recessions (REC), clinical attachment loss (CAL) patient morbidity. Nevertheless, no studies have ever directly compared FibreORS with MWF. Therefore, the aim of this randomized clinical trial (RCT) is to compare the efficacy of FibReORS versus MWF in the treatment of periodontal pockets associated with infrabony defects ≤3 mm at posterior natural teeth. Objectives The experimental hypothesis is: FibReORS is superior to MWF in achieving PPD closure (PPD <4 mm without BoP) at posterior teeth associated with shallow-moderate infrabony defects.

NCT ID: NCT06105125 Recruiting - Periodontitis Clinical Trials

Autologous Micrografts From the Palatal Mucosa for Periodontal Regeneration

Start date: November 2, 2023
Phase: N/A
Study type: Interventional

Some research studies have demonstrated that autologous micrografts made out of different oral tissues may enhance tissue regeneration. The primary aim of this study is to evaluate the clinical performance of a combined approach using an autologous micrograft derived from the palatal mucosa with an alloplastic scaffold for periodontal regeneration of intrabony defects in terms of clinical attachment level gain (primary outcome) and other secondary outcomes (probing pocket depth reduction, radiographic bone fill) compared to a scaffold alone. Moreover, this study aims to compare early wound healing and patient-reported outcome measures between the two groups.

NCT ID: NCT06105112 Recruiting - Periodontitis Clinical Trials

Periodontal Regeneration With Hyaluronic Acid or Enamel Matrix Derivatives

Start date: October 1, 2023
Phase: N/A
Study type: Interventional

To date, the quest for ideal biological inductors for periodontal regeneration is still ongoing, especially when facing non-containing defect anatomies. The primary aim of this study is to evaluate the clinical and radiographic performance of a bone graft combined with either enamel matrix derivatives or hyaluronic acid for periodontal regeneration of non-containing intrabony defects in terms of clinical attachment gain (primary outcome) and other secondary outcomes (probing pocket depth reduction, radiographic bone fill). Moreover, this study aims to compare early wound healing and patient-reported outcome measures.

NCT ID: NCT06099574 Recruiting - Periodontitis Clinical Trials

A Study on the Oral Health Status of Pregnant Women With Gestational Diabetes and Its Correlation With Oral Flora

OHSOGDMAOF
Start date: September 25, 2023
Phase:
Study type: Observational [Patient Registry]

The aim of this observational study was to find out the oral status of pregnant women with GDM. The main questions it aims to answer are. - What is the oral status of pregnant women with GDM - Does GDM cause changes in the patient's oral flora Participants will describe the main tasks that participants will be asked to complete. The researcher will compare the [periodontal health group] to see if there is [different flora].

NCT ID: NCT06090851 Recruiting - Periodontitis Clinical Trials

Herbal Pralines - Oral Health

Start date: September 15, 2023
Phase: N/A
Study type: Interventional

This randomized, double-blinded, placebo-controlled two-arm, parallel group clinical trial is designed to evaluate the impact of the consumption of two herbal pralines containing 200 mg nitrate on clinical signs of gingival inflammation (Bleeding on probing) without an accompanied professional mechanical plaque removal.

NCT ID: NCT06074861 Recruiting - Periodontitis Clinical Trials

Fasting-mimicking Diet and Periodontitis (FMD)

FMD
Start date: December 4, 2023
Phase: N/A
Study type: Interventional

Periodontitis (gum disease) leads to the formation of gum pockets. Its treatment involves deep cleaning of the teeth, to remove soft and hard tooth deposits under the gum line. Although in the long term this leads to improvement of the gum conditions and reduced inflammation, in the hours and days post-treatment, inflammation may increase, sometimes also associated with a high temperature. A method to reduce this response has not been found yet. The goal of this multi-centre randomized controlled trial is to to test if a diet which acts to mimic periodic fasting can influence responses in the mouth and throughout the body after treatment of gum disease in patients with advanced gum disease but general health conditions. Five Spanish centres (Universidad Complutense de Madrid, Universidad Internacional de Catalunya, Universidad de Murcia, Universidad de Santiago de Compostela, Universidad de Granada) will perform the clinical part of the study, whereas the King's College of London (Guy's Hospital) will provide the analyses and processing of the data. Researchers will include 24 patients in total. The main question it aims to answer is: - Is a mimic periodic fasting (together with the classical gum treatment) effective at reducing the local and systemic inflammation provoked by the gum disease (and by the same treatment) in the short- and medium term? Although all participants will receive the necessary gum treatment (deep cleaning), researchers will randomly assign them to one of two groups. The test group will follow three cycles (the same day of the treatment, and 45- and 85 days after treatment) of 5 days each of a fasting-mimicking diet (FMD). The FMD program is a plant-based diet program designed to attain fasting-like effects while providing both macro- and micronutrients to minimize the burden of fasting and adverse effects. The FMD consists of 100% ingredients that are generally regarded as safe (GRAS) and comprises proprietary vegetable-based soups, energy bars, energy drinks, cracker snacks, olives, herbal teas, and supplements. All items to be consumed per day are individually boxed. In contrast, the control group will continue with their current diet. All patients will complete dietary diaries to estimate calorie intake during this time period. Researchers will collect blood, stool, plaque and gingival crevicular fluid samples from each patient at different time points. Besides, they will call the patients one or two times during each FMD cycle to check that everything is proceeding properly and to solve any problems or concerns they may have. In addition, a trained registered dietitian will be available during the whole study period in case participants need some support or have doubts and/or questions. If participants miss multiple visits (e.g. 2/3) will be considered as a drop-out and, if they develop a serious medical condition, they might be excluded from the study. However, independently from the participation into this study, each patient will have their gum disease regularly treated. People with periodontal disease usually have a bad dietary-habits. This investigation with its holistic approach might lead people to modify their unbalanced diet due to the possible related local and systemic benefits. In addition, cycles of 5 days might consistently raise the adherence and willingness to follow such a fasting regime.

NCT ID: NCT06073704 Recruiting - Obesity Clinical Trials

Effects of Adjunct Antimicrobial Photodynamic Therapy in Periodontal Treatment of Patients With Obesity

Start date: October 9, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to compare the effects of adjuvant antimicrobial photodynamic therapy (aPDT) as an adjuvant of scaling and root planing with scaling and root planing alone for periodontal treatment in patients with periodontal disease and obesity. The main question it aims to answer are: Does adjuvant aPDT improves periodontal health? Are there differences in the proteomic profile of gingival fluid after both treatments? Participants will receive scaling and root planing complemented or not by aPDT. Results will be collected after 1, 3, and 6 months. Researchers will compare adjuvant aPDT treatment to regular treatment to see if it promotes reduction in inflammation and improvement in periodontal health.

NCT ID: NCT06068270 Recruiting - Clinical trials for Orthodontic Tooth Movement

Effect of MOPs During Orthodontic Movement in Periodontitis Patients

MOPorthoperi
Start date: December 15, 2023
Phase: N/A
Study type: Interventional

Micro-osteoperforations (MOPs) cause cortical bone injuries and consequently increase the expression of inflammatory mediators, allowing for increased bone and periodontal ligament remodeling associated with orthodontic movement. It remains unclear the effect of orthodontic intrusion combined with MOPs application on teeth with reduced periodontium. The general objective will be to determine the efficacy of MOPs during orthodontic tooth movement (OTM) in terms of periodontal and orthodontic outcomes in stage IV periodontitis patients, case type 2 with pathological tooth migration (PTM), characterized the presence of at least one flared tooth of the upper-anterior sextant with an intrabony defect (intrabony component <5mm)