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

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

Study Overview

• Status: Completed
• Conditions: Augmentation; TMJ; TMJ - Oral &Amp;Maxillofacial Surgery
• Intervention / Treatment: Procedure: Titanium Ring Inlay 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 Type: Interventional
• Enrollment (Actual): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Menoufia University, Egypt
    • Menoufia University, Faculty of Medicine, University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Titanium Ring Inlay Eminence Augmentation Group; Procedure: Novel titanium ring inlay eminence augmentation via modified ESS technique Inverted L-shaped osteotomy with controlled greenstick fracture Precise titanium ring (12-15mm diameter) implantation Surgical Protocol: Preauricular approach with subperiosteal dissection; Dual osteotomy (transverse mid-eminence + vertical parallel to skull base); Titanium ring inlay placement with anatomical contouring; Intraoperative functional assessment Postoperative Care: Standardized analgesic protocol; Physiotherapy protocol initiation at 2 weeks; Gradual return to function protocol Follow-up Schedule: Clinical assessments at 5 timepoints (T0-T4); Standardized outcome measurements (VAS, MIO, etc.) Key Characteristics: Single-arm interventional design All participants receive identical surgical protocol Standardized outcome assessment methodology Blinded evaluators for outcome measures (where applicable) Rationale for Single Arm Design: First-in-human evaluation of nov

Procedure: Titanium Ring Inlay Eminence Augmentation; Preauricular approach with subperiosteal dissection; Dual osteotomy (transverse mid-eminence + vertical parallel to skull base); Titanium ring inlay placement with anatomical contouring; Intraoperative functional assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional improvement	Measuring the Maximal interincisal opening (MIO; mm)	Baseline (T0); T1 (1 months postoperative); T2 (3 months postoperative); T3 (6 months postoperative); T4 (12 months postoperative).

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sinai University
• Collaborators: Menoufia University

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2024
• Primary Completion (Actual): April 3, 2025
• Study Completion (Actual): April 3, 2025

Study Registration Dates

• First Submitted: April 5, 2025
• First Submitted That Met QC Criteria: April 13, 2025
• First Posted (Actual): April 20, 2025

Study Record Updates

• Last Update Posted (Actual): April 20, 2025
• Last Update Submitted That Met QC Criteria: April 13, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Augmentation; TMJ; TMJ augmentation; Oral and Maxillofacial surgery
• Other Study ID Numbers: OMS 1-04-024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No