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| Name | Class |
|---|---|
| Menoufia University | OTHER |
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To evaluate the efficacy of titanium ring inlay in ESS technique in Temporomandibular joint eminence augmentation
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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:
Postoperative Care:
Follow-up Schedule:
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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Titanium Ring Inlay Eminence Augmentation | Procedure |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Score | Measuring the Visual Analogue Scale (VAS), pain score (1-10) | Baseline (T0); T1 (1 months postoperative); T2 (3 months postoperative); T3 (6 months postoperative); T4 (12 months postoperative). |
| Headache |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Menoufia University, Faculty of Medicine, University Hospital | Menoufia University | Egypt |
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.
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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.
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Measuring the Headache Assessment Presence Yes/No
| Baseline (T0); T1 (1 months postoperative); T2 (3 months postoperative); T3 (6 months postoperative); T4 (12 months postoperative). |
| Tinnitus | Tinnitus presence (Y/N) | Baseline (T0); T1 (1 months postoperative); T2 (3 months postoperative); T3 (6 months postoperative); T4 (12 months postoperative). |