Platelet Rich Fibrin With 1% Metformin for the Treatment of Intrabony Defects in Chronic Periodontitis : A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 主要终点
- radiographic defect depth reduction from baseline to 9 months.
研究概览
简要总结
ABSTRACT:
Background: Platelet-rich fibrin (PRF) is a second-generation platelet concentrate which releases various growth factors that promote tissue regeneration. Metformin (MF), a member of biguanide group has been shown to facilitate osteoblast differentiation and thus may exhibit a favourable effect on alveolar bone . Current study was designed to evaluate the combined efficacy of PRF and 1% MF gel with open flap debridement (OFD) in treatment of intrabony defects in chronic periodontitis (CP) subjects.
Methods: One hundred and twenty subjects with single defects were categorized into four treatment groups: OFD alone, OFD with PRF, OFD with 1% MF and OFD + PRF+1% MF. Clinical parameters like site specific plaque index (PI), modified sulcus bleeding index (mSBI), probing depth (PD), relative attachment level (RAL) and gingival marginal level (GML) were recorded at baseline before surgery and 9 months post-operatively. Percentage radiographic intra-bony defect depth reduction was evaluated using computer-aided software at baseline and 9 months.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Presence of 3- wall intrabony defects ≥3 mm deep (distance between alveolar crest and base of the defect on an intraoral periapical radiograph [IOPA] ) along with an interproximal probing depth (PD) ≥5 mm after phase I therapy (scaling and root planing [SRP] ) in asymptomatic molar teeth.
排除标准
- •Aggressive Periodontitis subjects
- •Subjects with systemic conditions known to affect the periodontal status
- •Medications known to affect the outcomes of periodontal therapy
- •Hematological disorders and insufficient platelet count (<200,000/mm3)
- •Pregnancy/lactation
- •Smoking and tobacco use in any form
- •Immunocompromised individuals. Those having unacceptable oral hygiene (plaque index [PI]16 > 1.5) after re-evaluation of Phase I therapy were also excluded from the study.
- •In addition, teeth with furcation defects, non vital teeth, carious teeth warranting restorations and mobility of at least grade II were also excluded.
研究组 & 干预措施
ARM1- open flap debridement (OFD)
open flap debridement done for 30 subjects. After debridement, Metformin or PRF was not added into the intrabony defect.
干预措施: open flap debridement (OFD) (Procedure)
ARM2- open flap debridement plus PRF(Platelet rich fibrin)
After open flap debridement, PRF( Platelet rich fibrin) was added into the intrabony defect.
No. of subjects= 30
干预措施: open flap debridement (OFD) (Procedure)
ARM2- open flap debridement plus PRF(Platelet rich fibrin)
After open flap debridement, PRF( Platelet rich fibrin) was added into the intrabony defect.
No. of subjects= 30
干预措施: Platelet rich fibrin (PRF) (Other)
ARM3- open flap debridement plus 1%Metformin
After open flap debridement, 1% metformin was added into the intrabony defect No. of subjects= 30
干预措施: open flap debridement (OFD) (Procedure)
ARM4- open flap debridement plus PRF plus metformin
After open flap debridement, PRF and 1% metformin was added into the intrabony defect.
No. of subject- 30
干预措施: Platelet rich fibrin (PRF) (Other)
ARM3- open flap debridement plus 1%Metformin
After open flap debridement, 1% metformin was added into the intrabony defect No. of subjects= 30
干预措施: Metformin (Drug)
ARM4- open flap debridement plus PRF plus metformin
After open flap debridement, PRF and 1% metformin was added into the intrabony defect.
No. of subject- 30
干预措施: open flap debridement (OFD) (Procedure)
ARM4- open flap debridement plus PRF plus metformin
After open flap debridement, PRF and 1% metformin was added into the intrabony defect.
No. of subject- 30
干预措施: Metformin (Drug)
结局指标
主要结局
radiographic defect depth reduction from baseline to 9 months.
时间窗: radiographic defect depth reduction from baseline to 9 months.
The primary outcome of the study was radiographic defect depth reduction from baseline to 9 months
次要结局
- Change in PD(Assessment of PD at 3,6 and 9 months)
- Change in RAL(Assessment of RAL at 3,6 and 9 months)
- Cgange in PI(Assessment of PI at 3,6 and 9 months)
- Change in GML(Assessment of GML at 3,6 and 9 months)
- Change in mSBI(Assessment of mSBI at 3,6 and 9 months)
研究者
Dr. A R Pradeep
Professor and head, department of periodontics
Government Dental College and Research Institute, Bangalore