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NCT Number: NCT07215156

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

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.

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Key information

Conditions

Stage II, Grade B Periodontitis Chronic Disease Chronic Periodontitis Disease Attributes Mouth Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 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 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.

Primary outcomes

  1. Change in Gingival Crevicular Fluid MMP-8 Levels

    Time frame: Baseline, 1 month, and 3 months

    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.

  2. Change in Clinical Attachment Level (CAL)

    Time frame: Baseline, 1 month, 3 months, and 6 months

    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.

  3. Change in Alveolar Bone Density

    Time frame: Baseline, 3 months, and 6 months

    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.

Secondary outcomes

  1. Change in Probing Pocket Depth (PPD)

    Time frame: Baseline, 1 month, 3 months, and 6 months

    Probing depth will be measured at six sites per tooth using a UNC-15 probe. Reduction in pocket depth indicates clinical improvement in periodontal status.

  2. Change in Gingival Index (GI) Score

    Time frame: Baseline, 1 month, 3 months, and 6 months

    Gingival inflammation will be assessed using the Löe and Silness Gingival Index. Decreased GI score reflects reduction in gingival inflammation.

  3. Change in Plaque Index (PI) Score

    Time frame: Baseline, 1 month, 3 months, and 6 months

    Oral hygiene status will be evaluated using the Silness and Löe Plaque Index. Reduction in PI indicates improved plaque control.

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

+20 10 96329474

Sponsors and collaborators

Lead sponsor

Kafrelsheikh University

Other

Registry information

Official study 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

Acronym: MET-CHX Perio

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 10, 2025
Registry last updated
Oct 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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