Treatment of intrabony defects

Phase 3

Active, not recruiting

• Conditions: Chronic periodontitis,

• Registration Number: CTRI/2023/08/057143
• Lead Sponsor: Raaja Sreepathy CS

Brief Summary

The aim of the present study is to compare the clinical and radiographic success rate of PRF and TPRF  using 1% Metformin gel in Intrabony Defects among chronic Periodontitis patients of 30 to 60 years of age. A total sample of 26 sites will be selected according to the following inclusion and exclusion criteria or selection parameters: INCLUSION CRITERIA: 1.•Apparently healthy individuals.•Presence of Intrabony defect (IBD) depth ≥3 mm and interproximal probing depth (PD) ≥5 mm after phase I therapy.

EXCLUSION CRITERIA: â€¢HISTORY OF: Aggressive Periodontitis. Smoking and tobacco use. Systemic conditions are known to affect the periodontal status. Medications are known to affect the gingival condition. Pregnant or lactating women. Hematological disorders and insufficient platelet count after re-evaluation of Phase I therapy. The selected samples will be randomized into two groups with 13 samples each. Under local anesthesia access Flap will be reflected. Root planing, Debridement, and root biomodification will be done. Blood will be drawn from systemically healthy patients and will be centrifuged in desired RPM. Based on the test and control group; PRF AND T-PRF MIXED WITH 1% METFORMIN GEL will be placed in the defect site respectively. The flap will be approximated and sutured, periodontal dressing will be given. Post-operatively patients will be prescribed appropriate analgesics and antibiotics for 5 days and OHI will be reinforced. Both the groups will be followed up for the assessment of clinical and radiographic parameters at 0,3,6 months intervals. The above-obtained data will be statistically analyzed.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-09
• Last Update Posted: 2024-09-07

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• 1.Apparently healthy individuals.
• Presence of Intrabony defect (IBD) depth ≥3 mm and interproximal probing depth (PD) ≥5 mm after phase I therapy.

Exclusion Criteria

• HISTORY OF : Aggressive Periodontitis.
• Smoking and tobacco use.
• Systemic conditions known to affect the periodontal status.
• Medications known to affect the gingival condition 2.
• Pregnant or lactating women.
• Hematological disorders and insufficient platelet count after re-evaluation of Phase I therapy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
3. GML – Gingival Marginal Level	Baseline, 3 months and 6 months
clinical outcome assessment.	Baseline, 3 months and 6 months
2. RAL- Relative Attachment Level	Baseline, 3 months and 6 months
1. PD- Probing Depth	Baseline, 3 months and 6 months

Secondary Outcome Measures

Name	Time	Method
radiographic parameters	1. Level of alveolar crest

Trial Locations

Locations (1)

Sri Venkateswara Dental College and Hospital; 🇮🇳 Kancheepuram, TAMIL NADU, India

Sri Venkateswara Dental College and Hospital

🇮🇳Kancheepuram, TAMIL NADU, India

Raaja Sreepathy CS

Principal investigator

9042503068

csraaja@gmail.com