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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2013 by Bradford Teaching Hospitals NHS Foundation Trust
Sponsor:
Information provided by (Responsible Party):
Madeleine Storey, Bradford Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01782521
First received: January 31, 2013
Last updated: February 1, 2013
Last verified: February 2013
  Purpose

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 Intervention
Bracket Failure Rate
Bonding Time Per Bracket
Adhesive Remnant Index for Type of Bond Failure
Length of Treatment
Peer Assessment Rating
Procedure: No primer

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Is a Primer Needed for Orthodontic Bonding? A Multi-centre RCT

Further study details as provided by Bradford Teaching Hospitals NHS Foundation Trust:

Primary Outcome Measures:
  • Rate of loss of orthodontic brackets [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Bonding time per bracket [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Peer Assessment rating [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 156
Study Start Date: March 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   10 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01782521

Contacts
Contact: Madeleine J Storey 01274365646 mstorey79@hotmail.co.uk
Contact: Nadine Houghton 01274365646 nadine.houghton@bthft.nhs.uk

Sponsors and Collaborators
Bradford Teaching Hospitals NHS Foundation Trust
Investigators
Principal Investigator: Madeleine J Storey University of Leeds
Study Director: Simon J Littlewood University of Leeds
Study Director: Nadine Houghton University of Leeds
  More Information

No publications provided

Responsible Party: Madeleine Storey, Speciality Registrar in Orthodontics, Bradford Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01782521     History of Changes
Other Study ID Numbers: primerstudy01
Study First Received: January 31, 2013
Last Updated: February 1, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Bradford Teaching Hospitals NHS Foundation Trust:
Bracket failure rate
Orthodontic bonding
Primer

ClinicalTrials.gov processed this record on November 27, 2014