An interventional study of Arm 1 Scaling and Root Planing (SRP) and Arm 2 Metformin Gel 1% (locally delivered) in Stage II, Grade B Periodontitis and Chronic Periodontitis, sponsored by Kafrelsheikh University. Not yet recruiting. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-10-10.
Sponsored by Kafrelsheikh University · Not applicable, Interventional, and Treatment
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.
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).
378 studies on the registry are indexed under Chronic Periodontitis; 23 are open to participants now.
This study's planned enrollment of 60 is above the median of 45 across 307 interventional studies indexed under Chronic Periodontitis.
Browse Chronic Periodontitis studies →Kafrelsheikh University is the lead sponsor of 285 studies on the registry; 110 are open to participants now.
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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.
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)
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)
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)
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.
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.
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.
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
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
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
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
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
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
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Plan to share: No
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Kafrelsheikh University