Clinical trial NCT06936072: Temporomandibular Joint Eminence Augmentation Using Titanium Ring Inlay: A New Surgical Technique
Official title: Temporomandibular Joint Eminence Augmentation Using Titanium Ring Inlay: A New Surgical Technique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: TMJ
Augmentation
TMJ - Oral &Amp;Maxillofacial Surgery
Keywords: TMJ
TMJ augmentation
Augmentation
Oral and Maxillofacial surgery
Lead sponsor: Sinai University
Sponsor class: OTHER
Collaborators: name: Menoufia University
First posted: 2025-04-20
Enrollment: 112
Sex: ALL
Minimum age (years): 25
Maximum age (years): 41
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model 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, Faculty of Dentistry, Sinai University OMS 01-04-024.
Primary purpose: TREATMENT

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.

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-

Primary outcomes:
measure: Functional improvement
timeFrame: Baseline (T0); T1 (1 months postoperative); T2 (3 months postoperative); T3 (6 months postoperative); T4 (12 months postoperative).
Secondary outcomes:
measure: Pain Score
timeFrame: Baseline (T0); T1 (1 months postoperative); T2 (3 months postoperative); T3 (6 months postoperative); T4 (12 months postoperative).
measure: Headache
timeFrame: Baseline (T0); T1 (1 months postoperative); T2 (3 months postoperative); T3 (6 months postoperative); T4 (12 months postoperative).
measure: Tinnitus
timeFrame: Baseline (T0); T1 (1 months postoperative); T2 (3 months postoperative); T3 (6 months postoperative); T4 (12 months postoperative).
Other outcomes:
Locations:
city: Menoufia University
country: Egypt
facility: Menoufia University, Faculty of Medicine, University Hospital
Study officials:
References: