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

NCT ID: NCT06936072

Last Updated: 2025-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-28
• Study Completion Date: 2025-04-03

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Titanium Ring Inlay Eminence Augmentation

Intervention Type: 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

Interventions

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

Intervention Type: PROCEDURE

Eligibility Criteria

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-

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 41 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Menoufia University

OTHER

Sponsor Role: collaborator

Sinai University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Moawed Ibrahim Ghoneim, PhD

Associate professor of Oral and Maxillofacial Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Menoufia University, Faculty of Medicine, University Hospital

Menoufia University, , Egypt

Countries

Egypt

Other Identifiers

OMS 1-04-024

Identifier Type: -

Identifier Source: org_study_id