Clinico-radiographic assessment of 1 percent metformin gel with Advanced-platelet-rich fibrin in the treatment of mandibular grade 2 furcation defects - A Split-Mouth Clinical study
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 21
- 试验地点
- 1
研究概览
简要总结
This split-mouth randomized controlled clinical trial aims to evaluate the clinical and radiographic effectiveness of 1 percent metformin gel used adjunctively with advanced platelet-rich fibrin (A-PRF) compared with A-PRF alone in the treatment of bilateral Grade 2 furcation defects. Twenty-one systemically healthy patients aged 30–55 years with chronic periodontitis and bilateral mandibular molar Grade 2 furcation involvement will be recruited following Phase I therapy. Test sites will receive open flap debridement (OFD) with 1 percent metformin gel and A-PRF, while control sites will be treated with OFD and A-PRF alone. Clinical parameters including probing pocket depth, clinical attachment level, plaque index, and furcation defect, along with radiographic bone fill, will be assessed at baseline, 3, 6, and 9 months using standardized stents and radiographic techniques. The primary outcome will be furcation defect reduction and radiographic bone fill, while secondary outcomes will include PPD reduction, CAL gain, and plaque index improvement, to determine whether adjunctive metformin provides superior regenerative benefits in Grade 2 furcation therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 30.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patiets willing and able to provide informed consent.
- •3.Diagnosed with chronic periodontitis.
- •4.Patients capable of maintaining good oral hygiene.
- •5.Asymptomatic mandibular first and second molars exhibiting radiolucency in the furcation area on intraoral periapical radiographs (IOPA) bilaterally.
- •6.Presence of bilateral Grade 2 furcation defects in mandibular molars that are endodontically vital (as confirmed clinically and radiographically).
- •7.Patients with a minimum of 20 permanent teeth, including at least two teeth with Grade 2 furcation defects, horizontal probing depth (PD) more than 3 mm, interproximal Probing depth more than or equal to 5 mm, and clinical attachment loss more than or equal to 3 mm, evaluated 8 weeks after Phase I therapy (scaling and root planing).
排除标准
- •1.Hematological disorders or immunocompromised status.
- •2.Pregnant or lactating women.
- •3.Smokers or users of any form of tobacco.
- •4.Use of medications known to interfere with wound healing or bone metabolism.
- •5.History of systemic antibiotic therapy or periodontal treatment within the past 6 months.
- •6.Restorations extending beyond the cemento-enamel junction (CEJ) at the defect site.
- •7.Indistinguishable CEJ, either clinically or radiographically.
- •8.Presence of periapical pathology, unrestored caries, defective restorations, root resorption, or vertical root fracture.
- •9.Tooth mobility classified as Miller Class 2 or greater.
- •10.Unacceptable oral hygiene (Plaque Index more than 1.5) after re-evaluation of Phase I therapy.
- •11.Patients unwilling to provide informed consent.
- •12.Known allergy to metformin or history of its systemic use.
研究者
Dr Isha Jaju
Pravara Institute of Medical Sciences