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Is a Primer Needed for Orthodontic Bonding? A Multi-centre Trial

NCT01782521 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2013-02-04

No results posted yet for this study

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.

Conditions

  • Bracket Failure Rate
  • Bonding Time Per Bracket
  • Adhesive Remnant Index for Type of Bond Failure
  • Length of Treatment
  • Peer Assessment Rating

Interventions

PROCEDURE

No primer

Primer not used when bonding orthodontic brackets

Sponsors & Collaborators

  • Bradford Teaching Hospitals NHS Foundation Trust

    lead OTHER_GOV

Principal Investigators

  • Madeleine J Storey · University of Leeds

  • Simon J Littlewood · University of Leeds

  • Nadine Houghton · University of Leeds

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2014-06-30
Completion
2014-06-30

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01782521 on ClinicalTrials.gov