The long-term effects of orthodontic growth modification for severe Class II anomalies

ISRCTN	ISRCTN26364810
DOI	https://doi.org/10.1186/ISRCTN26364810
Protocol serial number	G9901331
Sponsor	University of Manchester (UK)
Funder	Medical Research Council (MRC) (UK)

Submission date: 19/01/2001
Registration date: 19/01/2001
Last edited: 07/09/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Oral Health

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Kevin O'Brien
Scientific

Department of Dental Medicine and Surgery
University Dental Hospital of Manchester
Higher Cambridge Street
Manchester
M15 6FH
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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.
Ethics approval(s)	Not provided at time of registration.
Health condition(s) or problem(s) studied	Dental
Intervention	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.
Intervention type	Other
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.
Key secondary outcome measure(s)	Not provided at time of registration.
Completion date	30/09/2006

Eligibility

Participant type(s)	Patient
Age group	Child
Sex	Not Specified
Target sample size at registration	486
Key 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.
Key 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.
Date of first enrolment	01/04/2001
Date of final enrolment	30/09/2006

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Department of Dental Medicine and Surgery

Manchester
M15 6FH
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results of Study 1	01/09/2003		Yes	No