Is a Primer Needed for Orthodontic Bonding? A Multi-centre RCT
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 156
- Primary Endpoint
- Rate of loss of orthodontic brackets
Study Overview
Brief Summary
Orthodontic treatment is carried out by placing fixed attachments(brackets)on teeth with wires which run through them and create tooth movement. These metal brackets are bonded (glued) onto the tooth surface by a three step process. Firstly, a mild acid is used to roughen the tooth surface, secondly a free flowing glue (composite primer) is used to fill in the roughened pores and thirdly, the bracket is glued on to the tooth surface with a 'composite' material which sets hard by exposure to a high intensity light.The success of this procedure is measured by bracket failure rates.
The literature review suggests that the scientific evidence is not clear to indicate whether the use of a primer is absolutely essential to achieve acceptable bracket success rates in a clinical environment.
The primary aim of the study is to find out if the rate of loss of orthodontic brackets is clinically acceptable when they are glued onto the tooth surface without the use of a primer as compared to brackets bonded with a primer over a 12 month study period. The investigators will also investigate the Bonding time,Type of bracket bond failure,length of treatment and Peer Assessment Rating scores (PAR)
This RCT will be undertaken on consented NHS patients in 3 hospitals in Yorkshire region by multiple operators
The results from this study will help improve our knowledge of the best approach to bonding metal brackets on teeth. If the bracket failure rate is similar in both groups, this would indicate that the use of a primer is not always necessary. For patients, this would mean lesser time required to place brackets at the start of orthodontic treatment. For clinicians and NHS purchasers the outcome will influence cost effectiveness (as the primer is the most expensive component in the bonding process) and provide a framework for future studies.
Detailed Description
AIMS OF THE TRIAL The primary aim of the trial is to find out if clinically acceptable bracket failure rates can be achieved when metal brackets (fixed brace attachments) are glued (bonded) to teeth without the use of a primer as compared to brackets glued with a conventional primer in adolescent and adult orthodontic patients over a 12 month study period.
The other objectives are to determine if the gluing time per bracket is different between the groups and the type of glue failure at bracket-tooth interface using Adhesive Remnant Index. Length of treatment time and Peer Assessment Rating scores will also be analysed.
HYPOTHESES The null hypothesis for the primary outcome is - "there is no difference in the bracket failure rates when metal brackets are bonded with primer as compared to those which are bonded without a primer".
The null hypotheses for the secondary outcomes are - "there is no difference in the bonding time per bracket and the type of bond failure using Adhesive Remnant Index between the control and experimental group in this study.
METHOD OF INVESTIGATION
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 10 Years to 60 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •All consecutive patients who need fixed appliance treatment will be taken off the waiting list and no attempt will be made to match them for age, sex or malocclusion to ensure a representative sample.
- •Inclusion criteria is as follows -
- •Patients requiring single or two arch fixed appliance therapy (with no history of previous orthodontic treatment)including patients requiring orthognathic surgery
- •Willing to consent to participate in the trial
Exclusion Criteria
- •Patients with craniofacial anomalies
- •Patients with several buccal restorations or congenital enamel defects
- •Hypodontia cases (with more than one tooth missing in each quadrant)
Outcomes
Primary Outcomes
Rate of loss of orthodontic brackets
Time Frame: 12 months
The primary aim of this randomised clinical trial is to investigate if the rate of loss of orthodontic brackets is clinically acceptable when they are bonded onto the tooth surface without the use of a primer as compared to brackets bonded with a conventional primer in adolescent and adult orthodontic patients over a 12 month study period. This will be carried out by multiple operators to ensure a 'real world' orthodontic scenario.
Secondary Outcomes
- Peer Assessment rating(12 months)
- Type of failure using adhesive remnant index(12 months)
- Bonding time per bracket(12 months)
- Length of treatment(12 months)
Investigators
Madeleine Storey
Speciality Registrar in Orthodontics
Bradford Teaching Hospitals NHS Foundation Trust