A RCT comparing twin block wear for varying durations
Research type
Research Study
Full title
A prospective Randomized Controlled Trial measuring the effect of part time and full time twin block wear on skeletal and dental factors in adolescence with increased overjet during pre pubertal growth spurt
IRAS ID
120688
Contact name
Pratik Sharma
Contact email
Sponsor organisation
Queen Mary University of London
Research summary
The aim of this study is to assess skeletal(bone) and dental(teeth) changes occuring following wear of a twin block functional appliance(removable brace which postures the lower jaw forward to improve a discrepancy between the upper and lower jaw) for differing time periods. Functional appliances are ordinarily worn full time in adolescence between 11 and 14 years with a discrepancy between their upper and lower jaws. The reason it is worn between these ages is to avail of the pre pubertal growth spurt, evidence for full time wear is merely empirical.If this appliance only had to be worn part time it would have a significant change in orthodontics in terms of patient acceptance and compliance.We plan on recruiting 84 patients to our study and these subjects will be referred from hospital colleagues. We will randomly allocate the subjects into 2 groups, Group 1 will wear the appliance Full Time(24hours), group 2 will wear the appliance part time(12hours).
Eligible subjects should have the following criteria: Class II div 1 malocclusion(upper front teeth lying more forward than lower front teeth with upper front teeth proclined), Overjet(horizointal difference between upper and lower front teeth) measuring minimum of 7mm, Male subjects 12-14 years at the start of treatment, Female subjects 11-13 years at start of treatment, willingness of patient and parent to participate in the study.
The study will be conducted in the Dental Institute at the Royal London Hospital, this hospital setting will be the sole site.
The study will last for 15 months from the time the last patient is recruited. Participants will undergo initial records appointment where a radiograph and measurements will be taken followed by 12 months of functional appliance treatment where the patient will be reviewed at 6-8weekly intervals and measurements taken.A final radiograph will be taken at 15months.REC name
London - Queen Square Research Ethics Committee
REC reference
13/LO/1512
Date of REC Opinion
25 Nov 2013
REC opinion
Further Information Favourable Opinion