Is a Primer Needed for Orthodontic Bonding? A Multi-centre Trial
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|ClinicalTrials.gov Identifier: NCT01782521|
Recruitment Status : Unknown
Verified February 2013 by Madeleine Storey, Bradford Teaching Hospitals NHS Foundation Trust.
Recruitment status was: Not yet recruiting
First Posted : February 4, 2013
Last Update Posted : February 4, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Bracket Failure Rate Bonding Time Per Bracket Adhesive Remnant Index for Type of Bond Failure Length of Treatment Peer Assessment Rating||Procedure: No primer||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||156 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Is a Primer Needed for Orthodontic Bonding? A Multi-centre RCT|
|Study Start Date :||March 2013|
|Estimated Primary Completion Date :||June 2014|
|Estimated Study Completion Date :||June 2014|
No Intervention: Primer
Metal brackets bonded with primer
Experimental: No primer
Metal brackets bonded without primer
Procedure: No primer
Primer not used when bonding orthodontic brackets
- 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.
- Bonding time per bracket [ Time Frame: 12 months ]Bonding time per bracket − This outcome will measure any difference in the time required to bond a single bracket when a primer is not used to a bracket bonded with the conventional three step procedure
- Type of failure using adhesive remnant index [ Time Frame: 12 months ]Type of bond failure using Adhesive Remnant Index (ARI) − This outcome will measure the type of failure at the bracket−tooth interface, when a bracket fails in either group. The Adhesive Remnant Index is a standardised index which measures the amount of glue which remains over the tooth surface when a bracket fails and thereby categorises the weakest bond area between the tooth−bracket interface.
- Length of treatment [ Time Frame: 12 months ]
- Peer Assessment rating [ Time Frame: 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01782521
|Contact: Madeleine J Storeyemail@example.com|
|Contact: Nadine Houghtonfirstname.lastname@example.org|
|Principal Investigator:||Madeleine J Storey||University of Leeds|
|Study Director:||Simon J Littlewood||University of Leeds|
|Study Director:||Nadine Houghton||University of Leeds|