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临床试验/CTRI/2025/11/097172
CTRI/2025/11/097172已完成不适用

COMPARATIVE STUDY OF ORAL SUBMUCOUS FIBROSIS PATIENTS UNDERGOING RECONSTRUCTION WITH BUCCAL FAT PAD WITH AND WITHOUT PLATELET RICH FIBRIN

DR ROSHANI R AUTADE1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年11月18日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
1
主要终点
• Mouth opening in mm.

研究概览

简要总结

Numerous treatment modalities have evolved over time for treatment of OSMF. These include simple release of fibrosis, skin grafting, use of bilateral tongue flap, nasolabial flap, palatal island flap, bilateral radial artery forearm free flap, superficial temporal fascia flap, buccal fat pad. But each has its own drawback.

Buccal fat pad (BFP) is a supple lobulated mass and has been steadily gaining acceptance amongst surgeons as it is accessible and can be easily mobilized.

Platelet-rich fibrin (PRF) is a second generation platelet concentrate, developed in 2001 by Choukroun et al, now defined as ‘‘an immune and platelet concentrate collected on a single fibrin membrane containing all the constituents of a blood sample favorable to healing and immunity.’’ It has been revealed by clinical studies that this biomaterial promotes wound healing, wound sealing and hemostasis. PRF has certain clear advantages over other platelet concentrates which include simple, quick, single staged fabrication, cost effectiveness, reduced risk of antigenicity.

It has been shown that conversion of fibrinogen to fibrin in PRF is slow, with physiologically available thrombin of blood, creating a fibrin network similar to a natural one leading to more efficient cell migration and cell proliferation. It was hence proposed that grafting of autologous PRF membrane after excision of nondysplastic, potentially malignant, oral lesions could help in wound coverage and might also have a positive effect on wound healing and epithelialization.

We intend to apply the wound healing properties of PRF in treatment of the defects created by surgical excision of fibrous bands in OSMF patients by comparing it with the commonly used BFP flap and also compare the post operative mouth opening of the patients in both the groups.

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
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients with an interincisal mouth opening less than 20 mm.
  • 2.Biopsy proven OSMF.
  • 3.No systemic disorders.
  • 4.Patients who have quit tobacco use more than 6 months ago.

排除标准

  • Patients with an interincisal mouth opening greater than 20 mm.
  • Currently chewing tobacco or less than 6 months of quitting of habit.
  • Patients who have undergone any kind of treatment for OSMF previously.
  • • Patients with an uncontrolled systemic illness.
  • • Patients with altered hemodynamic values.
  • • Patients who have undergone treatment for malignancy (any radiotherapy or chemotherapy).
  • • Patients who have reduced mouth opening due to reasons other than OSMF.

结局指标

主要结局

• Mouth opening in mm.

时间窗: UPTO 6 MONTHS

• Post reconstruction healing (epithelialization) of the defect created by resection of the fibrous bands at the surgical site.

时间窗: UPTO 6 MONTHS

次要结局

  • • Reduction in the burning sensation post surgery will be assessed on subjective basis after 3 months.(3 MONTHS)

研究者

发起方
DR ROSHANI R AUTADE
申办方类型
Other [DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY, GOVERNMENT DENTAL COLLEGE AND HOSPITAL, JAMNAGAR]
责任方
Principal Investigator
主要研究者

AUTADE ROSHANI RAVINDRA

GOVERNMENT DENTAL COLLEGE AND HOSPITAL, JAMNAGAR

研究点 (1)

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