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临床试验/CTRI/2025/08/093259
CTRI/2025/08/093259尚未招募2 期

Pericardium membrane v/s collagen membrane with PRF in the treatment of furcation defects – a clinico -radiographic study

Dr Sruthy Sudir1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2025年9月16日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
10
试验地点
1
主要终点
Change in clinical attachment level (CAL) and probing pocket depth (PPD) at the furcation site from baseline to the endpoint (e.g., 6 or 9 months), measured clinically and confirmed radiographically.

研究概览

简要总结

The study will begin with a non-surgical phase, during which case history will be recorded in a standard proforma after obtaining written consent. Oral hygiene instructions will be provided, followed by scaling and root planing to control supra- and sub-gingival plaque. Clinical parameters, including plaque index (PI), gingival index (GI), probing pocket depth (PPD), clinical attachment level (CAL), and percentage of bleeding sites, along with radiographic parameters using CBCT for three-dimensional visualization and measurement of furcation defects (from cementoenamel junction to alveolar crest), will be recorded at baseline, 3 months, and 6 months after regenerative therapy. PRF will be prepared following Choukroun’s protocol by collecting 10 mL of blood without anticoagulant in a glass or glass-coated tube, immediately centrifuging at 2700 rpm for 12 minutes, and isolating the middle PRF clot between the acellular plasma layer and red corpuscle base. In the surgical phase, after routine preoperative tests, the procedure will be performed under local anesthesia (2% lignocaine with adrenaline 1:200,000). A full-thickness mucoperiosteal flap will be raised, and the furcation defect will be debrided. The defect will be filled with PRF combined with a Type I collagen membrane in Group A and PRF combined with a pericardium membrane in Group B, followed by flap suturing and standard postoperative care.

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 60.00 Year(s)(—)
性别
All

入选标准

  • Presence of minimum of 16 permanent teeth and more than or equal to 4 molars.
  • Maxillary and mandibular molars with the presence Grade II furcation involvement as detected on radiography.

排除标准

  • Patients with any systemic disease or currently under any medical treatment.
  • Pregnancy or lactation.
  • Third molars, lingual furcation sites of mandibular molars, bone loss extending to the apex.
  • Endodontically and non-endodontically treated teeth with periapical radiolucency, teeth with vertical fractures or cracks, mobility.
  • Smokers, people using other forms of smoking along with cigarettes.
  • Patients undergoing orthodontic treatment.
  • Teeth intended for extraction.
  • Teeth with metallic crowns.

结局指标

主要结局

Change in clinical attachment level (CAL) and probing pocket depth (PPD) at the furcation site from baseline to the endpoint (e.g., 6 or 9 months), measured clinically and confirmed radiographically.

时间窗: Change in clinical attachment level (CAL) and probing pocket depth (PPD) at the furcation site from baseline to the endpoint (e.g., 6 or 9 months), measured clinically and confirmed radiographically.

次要结局

  • Radiographic bone fill (%) at T1/T2/T3 (standardized periapical/CBCT measurements).

研究者

发起方
Dr Sruthy Sudir
申办方类型
Other [Individual sponsor]
责任方
Principal Investigator
主要研究者

Dr Sruthy Sudir

Vydehi Institute of Dental Sciences and Research Centre

研究点 (1)

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