Comfort and wearability of Orthodontic Mouthguards
Research type
Research Study
Full title
Comfort and Wearability of Orthodontic mouthguards compared to custom-made mouthguards
IRAS ID
206270
Contact name
Gursharan Minhas
Contact email
Sponsor organisation
Research and Development Department
Duration of Study in the UK
0 years, 6 months, 3 days
Research summary
The study will be a randomised controlled clinical trial with three treatment arms in a crossover design.Recruitment will occur from the orthodontic clinics at The Royal Surrey County Hospital. An electronically generated randomized sequence will be used and allocation will be undertaken by a member of the nursing team via opaque tamper proof envelopes. Subjects will be randomised either; Custom-made mouthguards, Orthodontic mouthforming mouthguard (“boil and bite”) or Orthodontic mouthguard (Instant fit)
Each participant will be allocated one of three mouthguards for a period of 6 - 8 weeks. Participants will be asked to keep a diary of sport played, how many minutes / times they have played each sport during this period. After this period, when they attend for their routine orthodontic review appointment, the 1st mouthguard will be collected and their diary analysed. They will be asked to complete a validated questionnaire and then be allocated their second mouthguard. This process will repeat 6 - 8 weeks later where they will be asked to complete a questionnaire following collection of the 2nd mouthguard and analysis of their diary. They will be issued with their third mouthguard and a new diary. At their 3rd follow up visit, 6 - 8 weeks later they will be asked to complete a questionnaire following collection of the 3rd mouthguard and analysis of their diary. At this point the trial is over and the results will be statistically analysed.
A member of the administration team in the orthodontic department at the Royal Surrey County Hospital will allocate and collect the questionnaires from the participants.
Participants will not be matched for gender, age or type of sport that they play (as long as a mouthguard is recommended for playing the sport - rugby, basketball, football, lacrosse, hockey, ice hockey, boxing and marshal arts.REC name
East of England - Cambridge South Research Ethics Committee
REC reference
16/EE/0304
Date of REC Opinion
9 Aug 2016
REC opinion
Further Information Favourable Opinion