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

Not Applicable

Completed

• Conditions: TMJ; Augmentation; TMJ - Oral &Amp;Maxillofacial Surgery

• Registration Number: NCT06936072
• Lead Sponsor: Sinai University

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 Timeline

• Study Start: 2024-04-28
• Status Verified: 2025-04
• Primary Completion: 2025-04-03
• Study Completion: 2025-04-03
• Study First Submitted: 2025-04-05
• Study First Submitted QC: 2025-04-13
• Last Update Submitted: 2025-04-13
• Study First Posted: 2025-04-20
• Last Update Posted: 2025-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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-

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Functional improvement	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 Outcome Measures

Name	Time	Method
Pain Score	Baseline (T0); T1 (1 months postoperative); T2 (3 months postoperative); T3 (6 months postoperative); T4 (12 months postoperative).	Measuring the Visual Analogue Scale (VAS), pain score (1-10)
Headache	Baseline (T0); T1 (1 months postoperative); T2 (3 months postoperative); T3 (6 months postoperative); T4 (12 months postoperative).	Measuring the Headache Assessment Presence Yes/No
Tinnitus	Baseline (T0); T1 (1 months postoperative); T2 (3 months postoperative); T3 (6 months postoperative); T4 (12 months postoperative).	Tinnitus presence (Y/N)

Trial Locations

Locations (1)

Menoufia University, Faculty of Medicine, University Hospital; 🇪🇬 Menoufia University, Egypt