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NCT07206134: COMET-OMF
Evaluation of Modified Omega Plate in the Management of Mandibular Fractures Compared With Conventional Fixation
NA trial testing Modified Omega bone plate for fixation of mandibular fractures in mental foramen region in Mandibular Fractures in 12 participants. Completed in 4 August 2025.
1 December 2024
Quick facts
| Lead sponsor | Tanta University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 12 |
| Start date | 1 March 2023 |
| Primary completion | 1 December 2024 |
| Estimated completion | 4 August 2025 |
| Sites | 1 location across Egypt |
Drugs / interventions tested
- Modified Omega bone plate for fixation of mandibular fractures in mental foramen region
- Conventional miniplates for fixation of mandibular fractures
Conditions studied
- Mandibular Fractures — all drugs for Mandibular Fractures →
- Fracture in Mental Nerve Region — all drugs for Fracture in Mental Nerve Region →
Sponsor
Tanta University
Who can join
Eligibility, any sex, with Mandibular Fractures or Fracture in Mental Nerve Region. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Twelve adult patients with mandibular fractures in the mental region were enrolled and randomly divided into two equal groups. Group I received fixation using custom-designed modified omega bone plates, while Group II was treated with conventional titanium miniplates following Champy's technique. Virtual surgical planning and 3D printing technology were used to fabricate customized plates in Group I. Clinical and radiographic assessments were conducted immediately, at 1 week, 3 months, and 6 months postoperatively. Parameters evaluated included soft tissue healing, pain, facial edema, lower lip paresthesia, maximal mouth opening, occlusion, fracture stability, and hardware integrity.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT07206134
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Mandibular Fractures
Currently open trials in the same condition.
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- NCT07245810 — Stryker Facial iD Universal Plate Configurator: A Retrospective Post Market Follow Up · recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07206134 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Tanta University
- Last refreshed: 3 October 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07206134.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing