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

NCT06936072 | Completed DMC

• 1 other identifier: OMS 1-04-024
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

TMJ; Augmentation; TMJ - Oral &Amp;Maxillofacial Surgery

Keywords

TMJ; TMJ augmentation; Augmentation; Oral and Maxillofacial surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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).

Study Arms (1)

Titanium Ring Inlay Eminence Augmentation Group

EXPERIMENTAL

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

Interventions

Titanium Ring Inlay Eminence Augmentation PROCEDURE

* 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

Titanium Ring Inlay Eminence Augmentation Group

Eligibility Criteria

• Age: 25 Years - 41 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Sinai University: lead
• Menoufia University: collaborator

Study Sites (1)

Menoufia University, Faculty of Medicine, University Hospital

Menoufia University, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of Oral and Maxillofacial Surgery

Model Details: 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.

Study Record Dates

• First Submitted: April 5, 2025
• First Posted: April 20, 2025
• Study Start: April 28, 2024
• Primary Completion: April 3, 2025
• Study Completion: April 3, 2025
• Last Updated: April 20, 2025

Record last verified: 2025-04

Locations

EG (1)