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

NCT ID: NCT07215156

Last Updated: 2025-10-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-06
• Study Completion Date: 2026-06-01

Brief 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.

Detailed Description

This is a randomized, controlled, single-blind clinical trial conducted at the Department of Oral Medicine, Periodontology, Oral Diagnosis, and Oral Radiology, Faculty of Dentistry, Kafrelsheikh University, Egypt. Sixty participants aged 18-60 years with Stage II, Grade B periodontitis will be enrolled. Participants will be randomly allocated (1:1:1) into three groups:

Group A (Control): SRP only

Group B (Test 1): SRP + 1% Metformin Gel

Group C (Test 2): SRP + 0.2% Chlorhexidine Gel

Subgingival gels will be applied after SRP using sterile syringes, followed by periodontal pack placement for one week. All patients will receive standardized oral hygiene instructions.

Outcome Measures:

Primary Outcomes: Clinical attachment level (CAL) changes, reduction in inflammatory markers (MMP-8), and radiographic bone density gain.

Secondary Outcomes: Probing pocket depth (PPD), plaque index (PI), and gingival index (GI).

Follow-up assessments will be performed at 1, 3, and 6 months. Data will be statistically analyzed using ANOVA and paired t-tests, with significance at p < 0.05.

The trial has been reviewed and approved by the Scientific Research Ethics Committee, Faculty of Dentistry, Kafrelsheikh University (Approval No. KFSIRB200-564, dated 24 February 2025).

Conditions

Stage II, Grade B Periodontitis; Chronic Periodontitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Arm 1 - Control: Scaling and Root Planing (SRP) Only

Participants receive conventional subgingival scaling and root planing (SRP) alone using hand and ultrasonic instruments, plus standardized oral hygiene instruction. No adjunctive local drug or gel is applied.

Group Type: ACTIVE_COMPARATOR

Arm 1 Scaling and Root Planing (SRP)

Intervention Type: PROCEDURE

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.

Arm 2 - Experimental: SRP + 1% Metformin Gel

Participants receive conventional SRP followed by subgingival application of 1% metformin gel into selected periodontal pockets; a periodontal dressing is placed for one week. Participants receive standardized oral hygiene instruction.

Group Type: EXPERIMENTAL

Arm 2 Metformin Gel 1% (locally delivered)

Intervention Type: DRUG

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.

Arm 3 - Experimental: SRP + 0.2% Chlorhexidine Gel

Participants receive conventional SRP followed by subgingival application of 0.2% chlorhexidine gel into selected periodontal pockets; a periodontal dressing is placed for one week. Participants receive standardized oral hygiene instruction.

Group Type: EXPERIMENTAL

Arm 3 Chlorhexidine Gel 0.2% (locally delivered)

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Adults aged 18-60 years.

Diagnosis of Stage II, Grade B periodontitis.

Probing pocket depths ≤ 5 mm with clinical attachment loss of 3-4 mm in selected sites.

Generally healthy individuals without systemic conditions affecting periodontal health.

Exclusion Criteria

Current smokers or users of tobacco products.

Pregnant or lactating women.

Known allergy to metformin or chlorhexidine.

Use of antibiotics or anti-inflammatory drugs within the past 3 months.

History of periodontal therapy within the past 6 months.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kafrelsheikh University

OTHER

Sponsor Role: lead

Responsible Party

Duaa Luwai Osman Hashim

(B.D.S. 2011 ) NATIONAL RIBAT UNIVERSITY

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Duaa Luwai Hashim, B.D.S (2011) NRU

Role: CONTACT

Doaaloai09@gmail.com

+20 10 96329474

Other Identifiers

KFSIRB200-564

Identifier Type: -

Identifier Source: org_study_id