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Completed

NCT Number: NCT06936072

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

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Key information

Conditions

TMJ Augmentation TMJ - Oral &Amp;Maxillofacial Surgery

Age range

25 year–41 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Menoufia University, Faculty of Medicine, University Hospital

Menoufia University, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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-

Treatment and study plan

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

Primary outcomes

  1. Functional improvement

    Time frame: 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 outcomes

  1. Pain Score

    Time frame: 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)

  2. Headache

    Time frame: 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

  3. Tinnitus

    Time frame: Baseline (T0); T1 (1 months postoperative); T2 (3 months postoperative); T3 (6 months postoperative); T4 (12 months postoperative).

    Tinnitus presence (Y/N)

Sponsors and collaborators

Lead sponsor

Sinai University

Other

Collaborators

  • Menoufia University

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 20, 2025
Registry last updated
Apr 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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