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NCT05536596
Pharmacological Treatment on the Recovery of Neurosensory Disturbance After Bilateral Sagittal Split Osteotomy
Phase 2, PHASE3 trial testing Orthognathic Surgery in Retrognathism in 220 participants. Status unknown.
30 June 2024
Quick facts
| Lead sponsor | Universitat Internacional de Catalunya |
|---|---|
| Phase | Phase 2, PHASE3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 220 |
| Start date | 30 September 2022 |
| Primary completion | 30 June 2024 |
| Estimated completion | 31 December 2024 |
Drugs / interventions tested
- Orthognathic Surgery
- Melatonin 10 MG Oral Tablet
- Hydroxycobalamin — full drug profile →
- Centrum — full drug profile →
Conditions studied
- Retrognathism — all drugs for Retrognathism →
- Prognathism — all drugs for Prognathism →
- Orthognathic Surgery — all drugs for Orthognathic Surgery →
- Neurosensory Disorder — all drugs for Neurosensory Disorder →
Sponsor
Universitat Internacional de Catalunya — full company profile →
Who can join
Adults 13 to 70, any sex, with Retrognathism or Prognathism. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The bilateral sagittal split osteotomy (BSSO) of the mandible is one of the most used surgical techniques to achieve a harmonious jaw relation in the context of orthognathic surgery. Nevertheless, one of its main complications is neurosensory damage to the inferior alveolar nerve, which can cause severe impact in the quality of life on patients who suffer from it permanently. The purpose of this randomized clinical trial is to provide rigorous scientific evidence of the pharmacological effect of 1) Melatonin, 2) combination uridine triphosphate (UTP), cytidine monophosphate (CMP), and hydroxycobalamin (UTP/CMP/hydroxycobalamin) and 3) hydroxycobalamin regarding neurosensory disturbances incidence and persistence after BSSO.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05536596
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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- Google Scholar
Related trials
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Trials testing the same drug.
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Other recruiting trials for Retrognathism
Currently open trials in the same condition.
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Other Universitat Internacional de Catalunya trials
Trials by the same sponsor.
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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 NCT05536596 (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 Universitat Internacional de Catalunya
- Last refreshed: 13 September 2022
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/NCT05536596.
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