Dental Oral Health Orthodontic growth modification
Conditions
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 applia
Sponsors
University of Manchester (UK)
Eligibility
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Not provided at time of registration. | — |
Countries
United Kingdom
Outcome results
None listed