RCT comparing self-etch primer and conventional etch and primer
Research type
Research Study
Full title
A randomised trial comparing ‘self-etch primer’ and ‘conventional etch and primer’ for orthodontic bonding in the hospital clinical setting.
IRAS ID
308065
Contact name
Billie-Jean Rainey
Contact email
Sponsor organisation
Western Health and Social Care Trust
Duration of Study in the UK
3 years, 6 months, 1 days
Research summary
This study will compare the effectiveness of two types of adhesive material for attaching orthodontic brackets to teeth; specifically, whether the use of one material "Conventional Etch and Primer (CEP)" will achieve a lower bracket failure rate than the use of different material "Self-etch Primer (SEP)."
Following the outbreak of COVID-19, many orthodontic treatments could no longer include aerosol-generating procedures, leading to variation in clinical technique and an observed increased incidence of patients returning with debonded brackets. A clinical audit was conducted locally, showing a substantial discrepancy in the rate of failure of the two different types of adhesive; with SEP 29% failure compared to CEP 15%. Both materials are presently used day-to-day within the department for the same purpose and licensed for such use within UK. No new materials or techniques are introduced by this trial.
We aim to identify the most successful and lasting material, which will be subsequently be used routinely within the department, leading to improved patient satisfaction, reduced wastage of department clinical time, resources and budget.
Participants in the trial will be selected from patients of the department who require upper and/or lower orthodontic fixed appliances to be placed for the straightening of their teeth and correction of errors in the bite; have a reasonable standard of dental hygiene; and give informed consent to involvement.
The study will be conducted in the Orthodontic Department, Altnagelvin Area Hospital, Northern Ireland; within clinical treatment rooms/cubicles.The duration of participation correlates to the time for the teeth to become aligned, during which the orthodontic braces are in place and the bracket survival will be monitored. This depends on factors such as compliance and attendance, physical features and degree of malocclusion; but is on average expected to be between 1 and 3 years. The timeframe for participants will be no different than for non-participants.
REC name
HSC REC B
REC reference
22/NI/0047
Date of REC Opinion
20 Apr 2022
REC opinion
Further Information Favourable Opinion