Clinical and Radiographic Evaluation of Subgingival 1% Metformin Gel Versus 0.05% Zoledronate Gel as an Adjunct to Minimally Invasive Nonsurgical Treatment of Intrabony Defects in Controlled Type 2 Diabetic Patients With Periodontitis. A Placebo Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Radiographic intra-bony defect depth
研究概览
简要总结
The present randomized placebo-controlled trial aims to evaluate and compare the clinical and radiographic efficacy of subgingivally delivered 0.05% zoledronate gel and 1% metformin gel as adjuncts to minimally invasive nonsurgical treatment of intrabony defects in patients with controlled type 2 diabetes mellitus and periodontitis.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosed with type 2 diabetes mellitus, with HbA1c levels <7.0% (controlled).
- •Diagnosis of chronic periodontitis (Stage III/IV, Grade B/C) with at least one intrabony defect of ≥3 mm depth, PPD ≥5 mm, and CAL ≥4 mm measured with a calibrated UNC-15 probe.
- •Angular bone loss of ≥3 mm measured on digital intraoral periapical radiographs and having three walled intrabony defects without involving furcation confirmed on cone beam computed tomography (CBCT).
排除标准
- •Pregnant or lactating women.
- •Patients on systemic bisphosphonate therapy or other medications known to affect bone metabolism.
- •Uncontrolled diabetes (HbA1c >8%) or other systemic diseases that could affect periodontal status.
- •History of radiation therapy to the head and neck
研究组 & 干预措施
Subgingival administration of placebo gel
MINST will be performed followed by Subgingival administration of placebo gel
干预措施: All participants will receive MINST (Procedure)
Subgingival administration of 0.05% zoledronate gel
MINST will be performed followed by Subgingival administration of 0.05% zoledronate gel
干预措施: All participants will receive MINST (Procedure)
Subgingival administration of 1% metformin gel
MINST will be performed followed by Subgingival administration of 1% metformin gel
干预措施: All participants will receive MINST (Procedure)
结局指标
主要结局
Radiographic intra-bony defect depth
时间窗: 6 months
The radiographic IBD depth will be measured by computer-aided software program, IBD depth will be measured on the radiograph by measuring the vertical distance from the crest of the alveolar bone to the base of the defect
次要结局
- Clinical attachment level(6 months)
- Periodontal pocket depth (PPD)(6 months)
研究者
Parryhan Mohamed Abdelsamie
Lecturer of periodontology
MTI University