Clinical efficacy of Photodynamic therapy and 1% Metformin gel as an adjunct to scaling and root planing in the treatment of Periodontitis A randomized clinical trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Clinical attachment level
研究概览
简要总结
In this current Randomized clinical trial, a total number of 25 patients who will be visiting the outpatient department of Periodontics will be recruited in the form of a split-mouth design based on the inclusion and exclusion criteria. After obtaining the informed consent, the patients will be randomly allocated into three groups. Group I will receive scaling and root planning alone, Group II will receive SRP along with photodynamic therapy, Group III will receive SRP along with 1% Metformin gel.
• Scaling and root planning will be done under Local Anesthesia using hand instruments followed by oral hygiene instructions.
• Photodynamic therapy - The selected sites will be rinsed with photosensitizer dye (Methylene blue 10 mg/ml.) employing a blunt cannula and excess photosensitizer is removed after one minute, followed by laser irradiation.
• 1% Metformin gel - The selected sites were treated with 1% MF (10µL) with the help of a syringe and blunt cannula directly into the periodontal pocket. Patients were instructed to refrain from chewing hard or adhesive foods Treated areas should be excluded during brushing. Usage of any interdental aids for one week should be strictly avoided.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Systemically healthy patients with sites showing probing depth 4-6 mm 2.No history of periodontal therapy or 3.use of antibiotics in the preceding 6 months.
排除标准
- •1.Patients with known systemic disease 2.Known or suspected allergy to Metformin [MF] 3.Patients on systemic MF or other oral antidiabetic therapy.
- •4.Patients with aggressive periodontitis 5.Use of tobacco in any form and alcoholism 6.Immunocompromised patients.
- •7.Pregnant or lactating females.
- •8.If the study reported additional treatments (e.g. Local or systemic antimicrobial therapy, adjunctive laser therapy, periodontal surgical therapy) other than SRP + aPDT.
结局指标
主要结局
Clinical attachment level
时间窗: baseline | 3 months | 6 months
Probing pocket depth
时间窗: baseline | 3 months | 6 months
次要结局
- Oral hygiene index(Gingival index)
研究者
Dr B SAI PRATHYUSHA
Sree sai dental college and research institute