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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Change in Gingival Crevicular Fluid MMP-8 Levels
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Single-blind design: participants are blinded to intervention allocation; clinicians applying treatment are aware of the group assignment.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Arm 1 Scaling and Root Planing (SRP) (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.
干预措施: Arm 2 Metformin Gel 1% (locally delivered) (Drug)
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.
干预措施: Arm 3 Chlorhexidine Gel 0.2% (locally delivered) (Drug)
结局指标
主要结局
Change in Gingival Crevicular Fluid MMP-8 Levels
时间窗: 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.
Change in Clinical Attachment Level (CAL)
时间窗: 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.
Change in Alveolar Bone Density
时间窗: 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.
次要结局
- 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)
研究者
Duaa Luwai Osman Hashim
(B.D.S. 2011 ) NATIONAL RIBAT UNIVERSITY
Kafrelsheikh University