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临床试验/CTRI/2025/05/086688
CTRI/2025/05/086688尚未招募4 期

Comparative evaluation of Titanium-platelet rich fibrin membrane and Collagen membrane along with Nanohydroxyapatite graft for the management of Grade II Furcation defects: A clinico-radiographic study.

Dr. Shivani Karmalkar1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年5月20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
40
试验地点
1
主要终点
4. Relative vertical clinical attachment level (RVCAL)

研究概览

简要总结

Aim of this study is to determine if there is a difference in clinical and radiographic parameters of Grade II Furcation defects treated with open flap debridement utilizing Nanohydroxyapatite graft and Titanium platelet-rich fibrin, when compared to open flap debridement with Nanohydroxyapatite graft and Collagen membrane. After obtaining informed consent and recording a comprehensive case history, 40 sites presenting with Grade II Furcation defects were enrolled and randomly assigned into two groups: a control group treated with OFD + NcHA bone graft + Collagen membrane., and a test group treated with OFD + NcHA bone graft + T-PRF membrane. Following phase I periodontal therapy, clinical re-evaluation was conducted to confirm suitability. Defect sites were allocated using the manual lottery method, with allocation concealment and blinded assessment to minimize bias. All surgical

procedures were performed by a single operator using the kirkland flap. In control group, after periodontal debridement is done, Grade II Furcation defects will receive Nanocrystalline hydroxyapatite graft (Sybograf™) and Collagen membrane( Healiguide) . After packing the graft and membrane into the defect, the flaps will be repositioned to their original position and will be secured using sutures. In test group, the Grade II Furcation defects will receive a Nanocrystalline hydroxyapatite graft (Sybograf™) with T-PRF membrane. The T-PRF will be prepared from the patient’s own blood. The venous blood will be drawn into two (5mL) titanium coated tubes and centrifuged at 2800 rpm for 12 minutes. After centrifugation, the T-PRF clots will be removed from the tubes using sterile tweezers, separated from the RBC base , and placed on sterile woven gauze for 20 minutes to release the serum and compressed using PRF box to form T-PRF membrane. After packing the defects with the graft and membrane the flaps will be repositioned to their original position and will be secured using sutures. Sutures will be removed after 7-10 days postoperatively.  All clinical parameters will be re-evaluated at 3 and 6 months after surgery while radiographic bone fill will be re-assessed at 6 months postoperatively.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Investigator Blinded

入排标准

年龄范围
25.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients exhibiting atleast one Glickman’s Grade II Furcation defect with Horizontal probing depth more than or equal to 3mm, vertical probing depth more than or equal to 5mm after evaluation of phase-I therapy
  • Radiographic evidence of inter-radicular bone loss.
  • Patient willing for surgery and ready to give written consent.

排除标准

  • Systemic illness known to affect the outcomes of periodontal therapy.
  • History of intake of antibiotics or other medications affecting the healing of periodontium in preceding 6 months.
  • Smokers, pregnant/lactating patients & patients with malocclusion will be excluded.
  • Platelet count less than 1,50,000/mm3
  • Patients with mobility of tooth more than or equal to Grade II.
  • 6.Patients allergic to medications.

结局指标

主要结局

4. Relative vertical clinical attachment level (RVCAL)

时间窗: 3 and 6 months after surgery

1. Full mouth Turesky Gilmore Modified Quigley Hein Plaque Index

时间窗: 3 and 6 months after surgery

7. Radiographic bone fill

时间窗: 3 and 6 months after surgery

2. Site specific Sulcus bleeding index (SBI) (Muhlemann et al 1971)

时间窗: 3 and 6 months after surgery

3.Site specific Probing pocket depth (PPD)

时间窗: 3 and 6 months after surgery

5. Relative horizontal clinical attachment level (RHCAL)

时间窗: 3 and 6 months after surgery

6.Gingival margin level (GML)

时间窗: 3 and 6 months after surgery

次要结局

未报告次要终点

研究者

发起方
Dr. Shivani Karmalkar
申办方类型
Other [self]

研究点 (1)

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