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

NCT07215156 | Not Yet Recruiting

• 1 other identifier: KFSIRB200-564
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Stage II, Grade B Periodontitis; Chronic Periodontitis

Keywords

Periodontitis; Stage II Grade B Periodontitis; Chronic Periodontitis; Scaling and Root Planing (SRP); Non-surgical Periodontal Therapy; Metformin Gel; Chlorhexidine Gel; Local Drug Delivery; Periodontal Regeneration; Inflammatory Markers (MMP-8)

Outcome Measures

Primary Outcomes (3)

• Change in Gingival Crevicular Fluid MMP-8 Levels

  Active MMP-8 concentrations will be quantified in gingival crevicular fluid using ELISA. PerioPaper strips will be used for collection. Reduction in MMP-8 indicates decreased periodontal inflammation.

  Baseline, 1 month, and 3 months

• Change in Clinical Attachment Level (CAL)

  CAL will be measured from the cementoenamel junction to the base of the periodontal pocket using a UNC-15 probe. Improvement in CAL reflects periodontal tissue healing and attachment gain.

  Baseline, 1 month, 3 months, and 6 months

• Change in Alveolar Bone Density

  Standardized periapical digital radiographs will be analyzed using Digora software to calculate mean gray-level values in the region of interest (1 mm below CEJ, 7 mm apically). An increase indicates bone density improvement.

  Baseline, 3 months, and 6 months

Secondary Outcomes (3)

• Change in Probing Pocket Depth (PPD)

  Baseline, 1 month, 3 months, and 6 months

• Change in Gingival Index (GI) Score

  Baseline, 1 month, 3 months, and 6 months

• Change in Plaque Index (PI) Score

  Baseline, 1 month, 3 months, and 6 months

Study Arms (3)

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

ACTIVE COMPARATOR

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.

Procedure: Arm 1 Scaling and Root Planing (SRP)

Arm 2 - Experimental: SRP + 1% Metformin Gel

EXPERIMENTAL

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.

Drug: Arm 2 Metformin Gel 1% (locally delivered)

Arm 3 - Experimental: SRP + 0.2% Chlorhexidine Gel

EXPERIMENTAL

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.

Drug: Arm 3 Chlorhexidine Gel 0.2% (locally delivered)

Interventions

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

Arm 2 Metformin Gel 1% (locally delivered) 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 2 - Experimental: SRP + 1% Metformin Gel

Arm 3 Chlorhexidine Gel 0.2% (locally delivered) 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.

Arm 3 - Experimental: SRP + 0.2% Chlorhexidine Gel

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kafrelsheikh University: lead

MeSH Terms

Conditions

Chronic Periodontitis; Periodontitis

Interventions

Root Planing

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dental Scaling; Dental Prophylaxis; Periodontics; Dentistry; Subgingival Curettage; Preventive Dentistry

Central Study Contacts

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

CONTACT

+20 10 96329474; Doaaloai09@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single-blind design: participants are blinded to intervention allocation; clinicians applying treatment are aware of the group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: (B.D.S. 2011 ) NATIONAL RIBAT UNIVERSITY

Model Details: Participants will be randomly assigned in a 1:1:1 ratio to one of three parallel groups: SRP alone, SRP + Metformin gel, or SRP + Chlorhexidine gel.

Study Record Dates

• First Submitted: October 2, 2025
• First Posted: October 10, 2025
• Study Start: October 6, 2025
• Primary Completion: April 10, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: October 10, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share