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| [ Print-friendly version ] |
| The long-term effects of orthodontic growth modification for severe Class II anomalies |
| ISRCTN | ISRCTN26364810 |
| DOI | 10.1186/ISRCTN26364810 |
| ClinicalTrials.gov identifier | |
| EudraCT number | |
| Public title | The long-term effects of orthodontic growth modification for severe Class II anomalies |
| Scientific title | |
| Acronym | N/A |
| Serial number at source | G9901331 |
| Study hypothesis |
The proposed study is a follow-up to an existing MRC funded study into orthodontic growth modification treatment for Class II skeletal malocclusion, which:
1. Investigated early orthodontic intervention compared to a control group 2. Compared two orthodontic appliances in later intervention The proposed study aims to 1. Compare early treatment patients and controls after any subsequent treatment received, to evaluate the long-term benefits/drawbacks of treatment timing 2. Evaluate the long-term effects of the appliances in the existing study 3. Start a new trial to compare the effect of two types of post-treatment retention on Class II patients who have finished orthodontic growth modification treatment ISRCTN61138858 - grant G9410454 preceded this trial. |
| Lay summary | |
| Ethics approval | Not provided at time of registration. |
| Study design | Randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Dental |
| Participants - inclusion criteria |
Studies 1 and 2 : Initial Dental overjet of greater than 7 mm; enrolment in the original Class II study.
Study 3: The patient has received Twin Block treatment followed by upper and lower fixed appliances; the original overjet was greater than or equal to 7 mm; any operator in the department provided treatment. |
| Participants - exclusion criteria |
Studies 1 and 2: Initial dental overjet of less than 7 mm; enrolment in the original Class II Study.
Study 3: Individuals with clefts of the lip and/or palate or any other suspected identifiable syndromes; people with midline diastema not caused by incisor proclination; people with hypodontia; treatment discontinued early/poor oral hygiene. |
| Anticipated start date | 01/04/2001 |
| Anticipated end date | 30/09/2006 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | Study 1=160, Study 2=166, Study 3=160, Total=486 |
| Interventions |
Study 1: Early orthodontic treatment with Twin Block or untreated control
Study 2: Orthodontic treatment with a Twin Block or a Herbst appliance Study 3: Orthodontic treatment with a Twin Block appliance randomised to fixed or removable orthodontic retention ISRCTN61138858 - grant G9410454 preceded this trial. |
| Primary outcome measure(s) |
Study 1
Children in the early group, already randomised to treatment or control, will be treated where necessary according to the protocol of the consultant. Records will be taken at the end of all treatment or after 5 years if there has been no treatment. The outcomes will be: - Whether further treatment was needed. - If treatment was needed. - Duration of treatment. - Did the treatment involve jaw surgery? - The number of visits required to complete treatment. - Dental change, recorded from study model analysis with the PAR index. - Skeletal and Dental change, measured with cephalometric analysis. - Change in patient perceptions with Piers Harris self-esteem measure. - The cost of the treatment - Trauma to the incisors? Study 2 Patients already randomised to treatment with a Herbst or a Twin Block appliance (treatment now completed) will be followed up for a period of 5 years and the following outcome measures will be collected: - Skeletal and dental change, measured with cephalometric analysis. - Dental change, recorded from study model analysis with the PAR index. - Change in patient perceptions with Piers Harris self-esteem measure. Study 3 Patients finishing growth modification treatment with a Twin Block appliance will be randomised to two groups. One group will be given upper and lower removable retaining appliances, the other will have fixed retaining appliances fitted to the inside of their anterior teeth. Outcomes: - Skeletal and dental change, measured with cephalometric analysis. - Dental change, recorded from study model analysis with the PAR index. - Change in patient perceptions with Piers Harris self-esteem measure. |
| Secondary outcome measure(s) | Not provided at time of registration. |
| Sources of funding | Medical Research Council (MRC) (UK) |
| Trial website | |
| Publications |
1. 2003 results of Study 1 in http://www.ncbi.nlm.nih.gov/pubmed/12970656
2. No publications for Study 2 and Study 3 |
| Contact name | Professor Kevin O'Brien |
| Address |
Department of Dental Medicine and Surgery
University Dental Hospital of Manchester Higher Cambridge Street |
| City/town | Manchester |
| Zip/Postcode | M15 6FH |
| Country | United Kingdom |
| Sponsor | University of Manchester (UK) |
| Address | Oxford Road |
| City/town | Manchester |
| Zip/Postcode | M13 9PL |
| Country | United Kingdom |
| Tel | +44 (0)161 306 6000 |
| Sponsor website: | http://www.manchester.ac.uk/ |
| Date applied | 19/01/2001 |
| Last edited | 07/09/2009 |
| Date ISRCTN assigned | 19/01/2001 |
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