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

Sinai University

Status: Completed

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

Treatments: Procedure: Titanium Ring Inlay Eminence Augmentation

Study type: Interventional

Funder types: Other

Identifiers

NCT06936072

OMS 1-04-024

Details and patient eligibility

About

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

Full 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.

Enrollment: 112 patients

Sex: All

Ages: 25 to 41 years old

Volunteers: No Healthy Volunteers

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-

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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112 participants in 1 patient group

Titanium Ring Inlay Eminence Augmentation Group

Experimental group

Description:

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

Treatment:

Procedure: Titanium Ring Inlay Eminence Augmentation