Glycemic Control in T2DM Through Non-Surgical Periodontal Therapy

• Status: Completed
• Trial end date: 2020-07-30
• Target enrollment: 0
• Participant gender: All

Summary

It is submitted that incident and prevalent chronic periodontal infection, known as chronic periodontitis (CP) possibly has a causal relationship with diabetes mellitus (DM) having effects on HbA1c, fasting plasma/ blood glucose (FPG/ FBG) and fasting plasma insulin (FPI) levels. Experimental research has suggested that treating CP may improve glycemic control and insulin resistance in Non-Insulin Dependent Type-2 DM patients (T2DM). However, there is limited data concerning the need and effects of adjunct antibiotic therapy (AAT) along with scaling root planning (SRP) in treating CP for long lasting results. Therefore, it is suggested that further research with larger samples must be undertaken for a successful periodontal therapy that may help improve glycemic control at desired levels and longer durations. This study is designed to evaluate effects of periodontal therapy [SRP, metronidazole (MET) and oral hygiene instructions (OHI)] through three-arm trial experiment comprising of SRP+MET+OHI, SRP+OHI and OHI+ Delayed Therapy (DT) groups on HbA1c, FBG, FPI levels and Insulin Resistance calculated through Homeostasis Model Assessment (HOMA-IR) to fill research gap. This study will target large number of individuals (N > 1000) at trial camps known as diabetes-periodontitis (Diab-Per) camps at three different campuses of Dow University of Health Sciences hospitals to be screened for presence of signs and symptoms of chronic periodontitis and type-2 diabetes Mellitus. The selected candidates will be referred to the base camp for further evaluation to be enrolled in trial and recruit 150 participants randomly allocated in each group (50 in each group). Post-therapy follow-up results will be assessed at 1, 3 and 6 months to evaluate short and long term changes in status of CP, FBG, FPI and HbA1c.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dow University of Health Sciences
• Collaborator: Higher Education Commission (Pakistan)
• Treatments: Anti-Bacterial Agents; Metronidazole

Criteria

Inclusion Criteria:

• Age between 35 to 65 years patients suffering from moderate to severe CP at baseline and having HbA1c level ≥7% and <10% at baseline with already diagnosed T2DM at least an year ago will be included as study sample. Moreover, those currently under oral glycemic therapy, having at least 16 natural teeth for the entire study duration and not under any definitive periodontal treatment since last 6 months of baseline visit will be considered as inclusion criteria along with no oral soft tissue lesions and those willing to sign informed consent will be considered to be recruited for this trial

Exclusion Criteria:

• Pregnant or breast feeding women

• Gestational Diabetes

• Patients currently receiving dialysis

• Patients with cardiac pacemakers

• Alcoholic

• Patients with any serious concurrent disease or complication with <1 year of life expectancy.

• Patients suffering from myelo-proliferating disorder (such as sickle cell disease) or under any such treatment that promotes a shift in the hemoglobin pattern.

• Under any anti-inflammatory drugs (daily for >7 consecutive days) within last 2 months of baseline visit, other than low dose aspirin prescribed for Cardio-vascular disease

• Under any systemic immunosuppressive drugs like corticosteroids, cyclosporine etc.

• Under any systemic antibiotics for >7 consecutive days within last four weeks of baseline visit.

• No medication for oral problems during last one month and during follow-up period that may affect interventions and HbA1c levels

• Any change in diabetes related medications in last 3 months of baseline visit, such as change in dose of any one hyperglycemic drug therapy by more than two-fold, addition or subtraction of an oral hypoglycemic agent or addition of insulin.

• Patients requiring any surgical (such as flap-surgery) or any non-surgical periodontal care that is restricted throughout study period depending upon the participants' group he/she may belong to.

• Patients with a history of night-grinding/ bruxism

• Patients with a history of allergic reaction with metronidazole

• Patients with mentally or/ and gross physical disability

• Failure to liaise on with the study protocol over the next 6 months

• With drawl from participation