Clinico-radiographic evaluation of one percent metformin gel and leucocyte-platelet rich fibrin in patients with periodontal intrabony defects a randomised clinical study.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- Self
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- To evaluate and compare the efficacy of one percent Metformin and leucocyte platelet rich fibrin in treatment of intrabony periodontal defects.
研究概览
简要总结
Introduction
Periodontal disease causes long lasting inflammation in the tissues surrounding the teeth which leads to loss of attachment and bone destruction. Intrabony periodontal defects are common findings and require regenerative treatment for predictable healing. Platelet rich fibrin is an autologous fibrin matrix that provides growth factors which support wound healing and bone regeneration. Metformin is an antidiabetic drug that has also shown beneficial effects on osteoblast activity and bone formation. Both materials have been studied separately but there is limited evidence on their combined use.
This randomized clinical study aims to evaluate and compare the effectiveness of one percent metformin gel and leucocyte rich platelet rich fibrin in the treatment of intrabony periodontal defects. Patients will be divided into four groups. group one will receive surgical debridement alone. group two will receive surgical debridement with leucocyte rich platelet rich fibrin. group three will receive surgical debridement with one percent metformin gel. group four will receive surgical debridement in combination with leucocyte rich platelet rich fibrin and one percent metformin gel. Clinical parameters including plaque index gingival index pocket depth and vertical clinical attachment loss along with radiographic assessment will be recorded at baseline three months and six months. This study will help to determine whether the combined use of leucocyte rich platelet rich fibrin and metformin offers additional benefits for periodontal regeneration.
Primary Outcome
Change in intrabony defect depth measured clinically and radiographically at baseline three months and six months.
Change in pocket depth at baseline three months and six months.
Change in vertical clinical attachment level at baseline three months and six months.
Change in plaque index and gingival index at baseline three months and six months.
Comparison of healing response among all four treatment groups.
Intervention Details
Group One Surgical Debridement Alone
Removal of granulation tissue scaling and root planing and flap closure.
Group Two Surgical Debridement with Leucocyte Rich Platelet Rich Fibrin
Surgical debridement followed by placement of leucocyte rich platelet rich fibrin prepared from patient blood. Flap closure is done.
Group Three Surgical Debridement with One Percent Metformin Gel
Surgical debridement followed by placement of one percent metformin gel into the defect area. Flap closure is done.
Group Four Surgical Debridement with Leucocyte Rich Platelet Rich Fibrin and One Percent Metformin Gel
Surgical debridement followed by placement of leucocyte rich platelet rich fibrin and one percent metformin gel combined in the defect. Flap closure is done.
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 and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients should be able to maintain proper oral hygiene.
- •Patients with chronic periodontitis with intrabony periodontal defects Patients should be free from any chronic systemic disease.
- •Patients who have signed the consent form.
排除标准
- •Patients suffering from any other condition affecting periodontal health i.e. aggressive periodontitis, etc.
- •Pregnant women and lactating mothers.
- •Patients suffering from any chronic systemic diseases.
- •Patients under medication which is known to affect prognosis of periodontal diseases.
结局指标
主要结局
To evaluate and compare the efficacy of one percent Metformin and leucocyte platelet rich fibrin in treatment of intrabony periodontal defects.
时间窗: outcome will be assessed on baseline that is on the day of surgery, 3 months, and 6 months .
次要结局
未报告次要终点
研究者
Mitali Parikh
Faculty of Dental Sciences, King George Medical University
