NCT01782521

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
156

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2013

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 4, 2013

Completed
25 days until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

February 4, 2013

Status Verified

February 1, 2013

Enrollment Period

1.3 years

First QC Date

January 31, 2013

Last Update Submit

February 1, 2013

Conditions

Bracket Failure RateBonding Time Per BracketAdhesive Remnant Index for Type of Bond FailureLength of TreatmentPeer Assessment Rating

Keywords

Bracket failure rateOrthodontic bondingPrimer

Outcome Measures

Primary Outcomes (1)

  • Rate of loss of orthodontic brackets

    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.

    12 months

Secondary Outcomes (4)

  • Bonding time per bracket

    12 months

  • Type of failure using adhesive remnant index

    12 months

  • Length of treatment

    12 months

  • Peer Assessment rating

    12 months

Study Arms (2)

Primer

NO INTERVENTION

Metal brackets bonded with primer

No primer

EXPERIMENTAL

Metal brackets bonded without primer

Procedure: No primer

Interventions

No primerPROCEDURE

Primer not used when bonding orthodontic brackets

No primer

Eligibility Criteria

Age10 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.
  • 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

You may not qualify if:

  • Patients with craniofacial anomalies
  • Patients with several buccal restorations or congenital enamel defects
  • Hypodontia cases (with more than one tooth missing in each quadrant)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Madeleine J Storey

    University of Leeds

    PRINCIPAL INVESTIGATOR

  • Simon J Littlewood

    University of Leeds

    STUDY DIRECTOR

  • Nadine Houghton

    University of Leeds

    STUDY DIRECTOR

Central Study Contacts

Madeleine J Storey

CONTACT

01274365646mstorey79@hotmail.co.uk

Nadine Houghton

CONTACT

01274365646nadine.houghton@bthft.nhs.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Speciality Registrar in Orthodontics

Study Record Dates

First Submitted

January 31, 2013

First Posted

February 4, 2013

Study Start

March 1, 2013

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

February 4, 2013

Record last verified: 2013-02