Comparative evaluation of adjunctive antimicrobial photodynamic therapy and adjunctive curcumin gel application with Scaling and Root Planing in Type II Diabetes patients with chronic periodontitis: A clinical and microbiological study.
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Porphyromonas gingivalis quantity in subgingival plaque sample
Study Overview
Brief Summary
This study is a randomized , parallel group trial showing the effect of Non surgical periodontal therapy and curcumin gel application versus antimicrobial photodynamic therapy on the quantity of porphyromonas gingivalis in the subgingival plaque sample on Type 2 diabetes with chronic periodontitis patients. It will be conducted in The Oxford Dental College , Bangalore in India and the duration for the completion of study will be 3 months. The primary outcome measure will be Porphyromonas gingivalis quantity in subgingival plaque sample before and after NSPT, NSPT and curcumin gel therapy versus NSPT and antimicrobial photodynamic therapy following 3 months. The secondary outcome measure will be clinical parameters - Gingival index, bleeding on probing, probing depth and clinical attachment loss before and after NSPT and curcumin gel therapy versus antimicrobial photodynamic therapy following 3 months.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 35.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •â€¢ Both male and female patients with the age from 35 -65yrs. • Both males and females diagnosed with T2DM (classification based on American Diabetes Association classification 2019):.
- •ïƒ˜ Fasting plasma glucose (FPG) ≥ 126 mg/dL (7.0 mmol/L). Fasting is defined as no caloric intake for at least 8 hr or  random plasma glucose ≥ 200 mg/dL (11.1 mmol/L) or  Glycated hemoglobin (HbA1c) ≥ 6.5% (48 mmol/mol) • Presence of Minimum of 20 natural teeth. • Patients diagnosed with Chronic periodontitis (stage III grade B) with PPD ≥ 6mm and (clinical attachment loss) CAL ≥ 5mm upon periodontal examination. (Classification based on 2017 World Work Shop).
Exclusion Criteria
- •â€¢ Patients with any underlying systemic disease other than diabetes.
- •â€¢ Pregnant and lactating women.
- •â€¢ Patients on antibiotic therapy and anti- inflammatory therapy the last 3 months.
- •â€¢ Patients with smoking habit.
- •â€¢ Significant changes in diabetes during the study period.
Outcomes
Primary Outcomes
Porphyromonas gingivalis quantity in subgingival plaque sample
Time Frame: 3 months
Secondary Outcomes
- Effect of curcumin and photodynamic therapy on gingival inflammation(3 months)
Investigators
Sheetal G Naik
The Oxford Dental College, Bangalore