CTRI/2025/04/083963尚未招募4 期
A comparative evaluation of TITANIUM PLATELET RICH FIBRIN alone and in combination with 1% METFORMIN GEL in the treatment of intra bony defects; A split- mouth study.
Dr J MANIKANTA1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2025年7月28日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- primary outcome : decreased pocket depth, reduced CAL , bone fill
研究概览
简要总结
| The split mouth study will consist of 12 systemically healthy patients visiting the Department of Periodontics. An informed consent will be |
| obtained from the patients. Initially scaling and root planning will be done under local anesthesia |
| followed by oral hygiene instruction. The patient will be recalled for |
| periodontal surgery. The following clinical and radiographic parameters |
| will be recorded at baseline, 6 months Stent fabrication Two acrylic stents for each site were prepared and |
| checked for proper stability one for CAL and the other for measuring the |
| depth of interproximal bony defects during the surgical procedures PRF-T rpm Just before the surgery, intravenous blood was |
| collected in a 10 ml sterile titanium test tube without anticoagulant by vein |
| puncturing of the antecubital vein The tubes were |
| immediately centrifuged at 3000 rpm for 10 minutes in a centrifuge machine |
| (C-852, REMI, Mumbai, INDIA). Blood centrifugation immediately after collection |
| allows the composition of a structured fibrin clot in the middle of the tube, |
| just between the red corpuscles at the bottom and acellular plasma (Platelet |
| Poor Plasma (PPP)) at the top TPRF clot thus |
| formed was separated using sterile tweezers and scissors and transferred onto |
| PRF box and a stable fibrin membrane was obtained by squeezing serum out of |
| the T-PRF clot 1%Metformin gel are formulated from |
| perioBiologics LLP laboratory Hydereabad. |
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
- 25.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Age 25 to 55 years 2) systematically healthy Patients with periodontitis​ 3) ​ Presence of Intra bony defect greater than 3mm 4) Minimum of 2 teeth with probing pocket depth greater than 5 mm on either side of the same arch 5) Clinical attachment loss greater than 4mm ​ 6) Depiction of angular defects in the intraoral periapical radiograph​.
排除标准
- •Patients with aggressive periodontitis​ 2) systemic diseases​ 3) patients who had no active periodontal therapy and drug history in the past 6 months 4) Smokers​ 5) Pregnant and lactating women were excluded from the study 6) Mobile nonvital ​poor prognosed teeth.
结局指标
主要结局
primary outcome : decreased pocket depth, reduced CAL , bone fill
时间窗: baseline and 6 months
secondary outcome: plaque index, gingival index, bleeding index
时间窗: baseline and 6 months
次要结局
- plaque index, gingival index, bleeding index.(base line and 6 months)
- decreased pocket depth, reduced CAL , bone fill(baseline to 6 months)
研究者
DR MANIKANTA JAJAM
DR. N.T.R UNIVERSITY OF HEALTH SCIENCES
研究点 (1)
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