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van CCT (UK)


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van CCT (UK)


Skeletal protraction improves facial profile in cleft patients


- candidate number27492
- NTR NumberNTR6559
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR4-jul-2017
- Secondary IDsMETc 2017/318 UMCG
- Public TitleSkeletal protraction improves facial profile in cleft patients
- Scientific TitleBone-anchored maxillary protraction in cleft patients
- ACRONYMN/A
- hypothesisBone-anchored maxillary protraction therapy improves facial profile in cleft children.
- Healt Condition(s) or Problem(s) studiedMalocclusion class 3, Cleft, Cleft
- Inclusion criteria- Cleft subjects aged at 10-12 at the start of treatment with mild to moderate Class III malocclusion
- Exclusion criteria- Class I or Class II malocclusion
- Subjects with severe Class III malocclusion, other serious medical conditions or stopped treatment because of moving or other unexpected reasons.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupFactorial
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-jan-2015
- planned closingdate1-dec-2018
- Target number of participants40
- InterventionsBone-anchored maxillary protraction
- Primary outcome- displacement of specific (growth-indicating) anatomic landmarks on cone-beam CT and lateral cephalograms
- lip projection on light photographs
- Secondary outcomeN/A
- Timepoints1.5 year follow up, 3.5 year follow up and 5 year follow up
- Trial web siteUMCG research register http://cms.umcg.nl/onderzoek/toolbox_research/themas/toolbox/?subwebbranch=
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES RM Steegman
- CONTACT for SCIENTIFIC QUERIESProf. Dr. Y. Ren
- Sponsor/Initiator
- Funding
(Source(s) of Monetary or Material Support)
- PublicationsN/A
- Brief summaryAll patients with isolated, unilateral complete cleft lip and palate between 10-12 years were included. All patients have been under treatment by one orthodontist at the Department of Orthodontics of University Medical Center Groningen, the Netherlands and have undergone a series of interdisciplinary treatments within the same medical center.
- Main changes (audit trail)
- RECORD4-jul-2017 - 30-jul-2017


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