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临床试验/CTRI/2026/01/100477
CTRI/2026/01/100477尚未招募4 期

Comparative assessment of masticatory efficiency surgical outcomes in temporomandibular joint ankylosis patients treated with pedicled buccal fat pad & free abdominal fat graft interpositional arthroplasty: An ambispective-cum-prospective study

Aparna Mahajan1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2026年2月2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
26
试验地点
1

研究概览

简要总结

Interpositional arthroplasty has emerged as the preferred treatment for TMJA due to its ability to prevent re-ankylosis by inhibiting osteoblastic growth between the bone surfaces Studies by Wolford and Karras  have shown that autologous transplantation of abdominal fat around the TMJ reduces fibrosis and heterotopic bone formation, leading to improved range of motion Dimitroulis utilized a dermis fat graft from the groin for interposition in the TMJ however harvesting fat grafts from distant sites poses risks of morbidity and complications The BFP situated nearby the TMJ offers an alternative with ample volume and a dependable blood supply making it a logical choice for grafting without the need for distant site harvesting  Additionally  minimal changes in facial contour have been reported after the removal of the superior extension of the buccal fat pad which can be advantageous in cases of unilateral TMJA by addressing facial asymmetry

Roy et al compared the volumetric shrinkage of grafts and surgical outcomes favoring abdominal fat graft over pedicled buccal fat pad in treating TMJA Another study by Ejaz et al in 2022 evaluated masticatory function including bite force and chewing efficiency in patients with unilateral TMJ ankylosis treated with pedicled BFP interpositional arthroplasty alone Despite numerous studies on TMJA and graft materials individually there is limited direct comparison between pedicled BFP and free abdominal fat as interpositional grafts in terms of surgical outcome and  masticatory efficiency Therefore a prospective interventional study is warranted to compare the efficacy of these two methods This study is based on the hypothesis that there is no significant difference in surgical outcomes and masticatory efficiency in both free abdominal fat and pedicled BFP as an interpositional graft in TMJA patients

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

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

入选标准

  • 1] Presence of Temporomandibular joint ankylosis (Sawhney type I-IV).
  • 2] ASA I, II category patients.
  • 3] Patients who are willing to come for the follow up visit.

排除标准

  • 1] Patients with uncontrolled systemic diseases.
  • 2] Pregnant patients.
  • 3] Patients with metabolic fat disorders or other fat degeneration disorders or with local abdominal or buccal mucosa pathology.
  • 4] Patients who do not provide written informed consent.
  • 5] Patients who refuse to attend all scheduled visits.

研究者

发起方
Aparna Mahajan
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Aparna Mahajan

AIIMS Rishikesh

研究点 (1)

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