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Clinical Trials/NCT06936072
NCT06936072CompletedNot Applicable

Temporomandibular Joint Eminence Augmentation Using Titanium Ring Inlay: A New Surgical Technique

Sinai University1 site in 1 country112 target enrollmentStarted: April 28, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
112
Locations
1
Primary Endpoint
Functional improvement

Study Overview

Brief Summary

To evaluate the efficacy of titanium ring inlay in ESS technique in Temporomandibular joint eminence augmentation

Detailed Description

Background:Temporomandibular joint (TMJ) disorders affect approximately 5-12% of the population, with eminence augmentation being a challenging surgical intervention. Current techniques using autogenous grafts or alloplastic materials present limitations including donor site morbidity, resorption, and implant failure. This study evaluates a novel titanium ring inlay technique for TMJ eminence augmentation, which may offer improved stability, osseointegration, and functional outcomes.

Patients and Methods: A prospective study was conducted on 100 patients (28 males, 72 females; age range: 25-41 years) with TMJ Temporomandibular joint eminence augmentation. Study was performed after ethical approval from Research Ethics Committee, Faculty of Dentistry, Sinai University OMS 01-04-024; . Titanium ring inlay procedure was performed to Temporomandibular joint eminence augmentation. Preoperative and postoperative assessments included pain levels (VAS pain), maximum mouth opening (MMO), Clicking during mouth opening, Headach presence, tinnitus and subjective patient feedback.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
25 Years to 41 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Diagnosed TMJ dysfunction requiring eminence augmentation
  • Failed conservative management (≥3 months)
  • Adequate bone stock for inlay placement
  • Willingness to comply with follow-up protocol

Exclusion Criteria

  • Systemic conditions contraindicating surgery
  • Active TMJ infection
  • Previous TMJ surgery
  • Pregnancy
  • Neuromuscular disorders-

Outcomes

Primary Outcomes

Functional improvement

Time Frame: Baseline (T0); T1 (1 months postoperative); T2 (3 months postoperative); T3 (6 months postoperative); T4 (12 months postoperative).

Measuring the Maximal interincisal opening (MIO; mm)

Secondary Outcomes

  • Pain Score(Baseline (T0); T1 (1 months postoperative); T2 (3 months postoperative); T3 (6 months postoperative); T4 (12 months postoperative).)
  • Headache(Baseline (T0); T1 (1 months postoperative); T2 (3 months postoperative); T3 (6 months postoperative); T4 (12 months postoperative).)
  • Tinnitus(Baseline (T0); T1 (1 months postoperative); T2 (3 months postoperative); T3 (6 months postoperative); T4 (12 months postoperative).)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mohamed Moawed Ibrahim Ghoneim, PhD

Associate professor of Oral and Maxillofacial Surgery

Sinai University

Study Sites (1)

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