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NCT03511989
Transverse Maxillary Expansion With a Segmental Le Fort I Osteotomy or Surgically Assisted Rapid Maxillary Expansion (SARME)
NA trial testing Bone borne distractor in Maxilla; Hypoplasia in 90 participants. Status unknown.
1 August 2023
Quick facts
| Lead sponsor | Aalborg University Hospital |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 90 |
| Start date | 1 August 2016 |
| Primary completion | 1 August 2023 |
| Estimated completion | 1 August 2025 |
| Sites | 1 location across Denmark |
Drugs / interventions tested
- Bone borne distractor
- Tooth borne distractor
- Segmental LF1 Osteotomy group 1
- Segmental LF1 Osteotomy group 2
- Segmental LF1 Osteotomy group 3
Conditions studied
- Maxilla; Hypoplasia — all drugs for Maxilla; Hypoplasia →
Sponsor
Aalborg University Hospital
Who can join
15 and older, any sex, with Maxilla; Hypoplasia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
To assess transverse dental and skeletal expansion and stability after SLFIO with no fixation of the palatal vault compared to stabilization of the palatal vault with an autogenous bone block graft or fixation of the palatal osteotomy site with a biodegradable plate. To assess transverse maxillary dental and skeletal expansion and stability after SARME with a TB distraction appliance compared to a BB distraction appliance.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03511989
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT03511989 (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 Aalborg University Hospital
- Last refreshed: 9 January 2020
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/NCT03511989.
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