Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07215156
NA

Metformin Versus Chlorhexidine Gel as Adjuncts to Scaling and Root Planing in Stage II Grade B Periodontitis

Sponsor: Kafrelsheikh University

View on ClinicalTrials.gov

Summary

This clinical trial is designed to evaluate two locally delivered gels, metformin and chlorhexidine, as adjunctive therapies to scaling and root planing (SRP) in patients with Stage II, Grade B periodontitis. Periodontitis is a chronic inflammatory condition that damages the supporting tissues of the teeth. Although SRP is the standard non-surgical treatment, it may not fully eliminate harmful bacteria or prevent disease recurrence. Chlorhexidine is a widely used antimicrobial gel, while metformin, a medication commonly prescribed for diabetes, has shown anti-inflammatory and bone-supportive effects when used locally in the gums. This study will directly compare the effectiveness of 1% metformin gel and 0.2% chlorhexidine gel, both applied subgingivally after SRP, against SRP alone. Sixty adult participants diagnosed with Stage II, Grade B periodontitis will be randomly assigned into three groups: SRP only (control), SRP plus metformin gel, and SRP plus chlorhexidine gel. Clinical outcomes (plaque index, gingival index, probing pocket depth, and clinical attachment level), inflammatory markers (MMP-8 in gingival crevicular fluid), and radiographic bone density will be measured at baseline, 1 month, 3 months, and 6 months. The goal is to determine whether metformin gel or chlorhexidine gel provides superior improvements in periodontal healing when compared with SRP alone. Findings from this trial may guide evidence-based decisions on optimizing non-surgical periodontal therapy.

Official title: Comparative Study Between Metformin and Chlorhexidine Gel as Adjunctive to Conventional Non-Surgical Treatment of Stage II Grade B Periodontitis: A Randomized Controlled Clinical Trial

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2025-10-06

Completion Date

2026-06-01

Last Updated

2025-10-10

Healthy Volunteers

No

Interventions

PROCEDURE

Arm 1 Scaling and Root Planing (SRP)

Full-mouth supragingival and subgingival debridement performed with ultrasonic and hand instruments (Gracey curettes). SRP performed to remove plaque and calculus and root-surface decontamination. Standardized oral hygiene instruction is provided after the procedure.

DRUG

Arm 2 Metformin Gel 1% (locally delivered)

1% metformin hydrochloride formulated in a gellan-gum gel base (as per protocol). After SRP, gel is delivered subgingivally with a sterile syringe (23-gauge cannula) and left undisturbed for approximately 5 minutes; a periodontal dressing is placed for one week. Gingival crevicular fluid sampling and clinical follow-up at 1, 3, and 6 months.

DRUG

Arm 3 Chlorhexidine Gel 0.2% (locally delivered)

0.2% chlorhexidine digluconate gel prepared in carbopol base. After SRP, gel is delivered subgingivally with a sterile syringe and left undisturbed for approximately 5 minutes; a periodontal dressing is placed for one week. Clinical follow-up at 1, 3, and 6 months.