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| The long-term effects of orthodontic growth modification for severe Class II anomalies |
| Source of record | UK Trials |
| ISRCTN | ISRCTN26364810 |
| Date ISRCTN assigned | 19/01/2001 |
| Local reference number(s) | G9901331 |
| Public title | The long-term effects of orthodontic growth modification for severe Class II anomalies |
| Scientific title | |
| Acronym | N/A |
| Disease/condition/study domain | Dental |
| 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 |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration. |
| Countries of trial | United Kingdom |
| 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. |
| Patient information material | |
| Anticipated start date | 01/04/2001 |
| Anticipated end date | 30/09/2006 |
| Status of trial | Completed |
| Target number of participants | 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 |
| Primary outcome measure(s) | Study one 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 two 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 three 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 (UK) |
| Sponsor name | University of Manchester (UK) |
| Sponsor details | Oxford Road Manchester United Kingdom M13 9PL |
| Sponsor telephone | +44 (0)161 306 6000 |
| Sponsor website | http://www.manchester.ac.uk/ |
| Contact name | Professor Kevin O'Brien |
| Contact details | Department of Dental Medicine and Surgery University Dental Hospital of Manchester Higher Cambridge Street Manchester United Kingdom M15 6FH |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN26364810 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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