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

ConditionsStage II, Grade B PeriodontitisChronic Periodontitis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorKafrelsheikh University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Arm 1 Scaling and Root Planing (SRP)

    Procedure/Surgery

    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.

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: Arm 1 - Control: Scaling and Root Planing (SRP) OnlyActive comparator 1 intervention
Group B: Arm 2 - Experimental: SRP + 1% Metformin GelExperimental treatment 1 intervention
Group C: Arm 3 - Experimental: SRP + 0.2% Chlorhexidine GelExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline, 1 month, and 3 months
2

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.

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

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.

Time frame
Baseline, 3 months, and 6 months

Secondary outcomes

1

Change in Probing Pocket Depth (PPD)

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.

Time frame
Baseline, 1 month, 3 months, and 6 months
2

Change in Gingival Index (GI) Score

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

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

Change in Plaque Index (PI) Score

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

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kafrelsheikh University

Lead sponsor

Source ClinicalTrials.gov

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