RMGI v Composite for Orthodontic Bonding

January 24, 2018 updated by: Sheffield Teaching Hospitals NHS Foundation Trust

Resin-modified Glass Ionomer or Composite for Orthodontic Bonding? - a Multi-centre, Randomised, Single Blinded Clinical Trial

Demineralization during orthodontic (brace) treatment is a common clinical problem leading to unsightly white or brown marks on the teeth. A recent systematic review has shown little evidence that current methods of delivering fluoride are effective at reducing this problem.

Design: A multi-centre randomised single blinded controlled clinical trial will be conducted with two parallel groups.

Setting: The trial patients will be treated by eight named operators on the Specialist List for Orthodontics held by the General Dental Council and who work either within the hospital service or specialist orthodontic practice. The sample size calculation suggests that each operator will need to treat 40 patients in the trial (approx 1 session per week) plus up to 10 familiarisation patients before.

Planned trial interventions: Brackets will be bonded to all teeth in front of the first permanent molars with either a resin-modified glass ionomer cement (Fuji Ortho LC) or a light cured composite control (Transbond). The material to be bonded will be allocated randomly.

Outcome measures: The two main outcome measures will be the difference in demineralization of the anterior teeth before and after treatment assessed from photographs and the number of debonded brackets during treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Demineralization (dental decay) around fixed appliance components has been reported to occur in up to 95% of cases where brackets are bonded with composite resins. Although early lesions appear clinically as opaque white or brown areas, if mineral loss continues cavitation will occur. Following appliance removal, the lesions may regress or disappear but may still present an aesthetic problem more than 5 years after appliance removal. Fluoride is known to inhibit lesion development and to enhance remineralization following treatment. Resin-modified glass ionomer cements, which release and absorb fluoride, may be used for bracket bonding thereby offering the possibility of less demineralization around bonded attachments. In addition, these cements appear to behave as reliably as composite in terms of bracket failure rate recorded but these data are from case series rather than optimally designed randomised clinical trials. A bonding agent that can behave as reliably as composite and minimize unwanted enamel demineralization would be optimal; saving on restorative costs that may be required should cavitation occur. From the patients perspective, subjective assessment of treatment outcome is likely to be enhanced as ugly demineralised enamel white lesions will be eliminated.

Study Type

Interventional

Enrollment (Actual)

210

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
      • Cork, Ireland
        • Cork Dental Hospital and School
  • United Kingdom
    • Cheshire
      • Crewe, Cheshire, United Kingdom
        • Hightown Orthodontics
    • Hertfordshire
      • Stevenage, Hertfordshire, United Kingdom, SG1 1DU
        • Inline Orthodontics
    • South Yorkshire
      • Sheffield, South Yorkshire, United Kingdom, S10 2TA
        • Charles Clifford Dental Hospital
      • Sheffield, South Yorkshire, United Kingdom, S10
        • The Orthodontic Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 11 years of age or older;
  • In good general health;
  • Brush his/her teeth at least once per day;
  • Have canine and incisor teeth fully erupted and of normal form on either side of upper/lower arch;
  • Require upper and/or lower pre-adjusted edgewise fixed appliance therapy;
  • Have given written informed consent;
  • Be willing and able to comply with the trial regime.

Exclusion Criteria:

  • Undergoing orthognathic treatment;
  • Patients with a cleft of the lip or palate;
  • Patients with any heart condition or disease necessitating antibiotic cover;
  • Diabetes mellitus; epilepsy; physical or mental handicap;
  • Poor periodontal health, including the presence of supragingival calculus/subgingival calculus/periodontal pocketing greater than 3mm;
  • Gross or uncontrolled caries;
  • Labial demineralisation on a canine or incisor tooth;
  • Absent or peg-shaped lateral incisors;
  • Palatal canines and /or ectopic unerupted incisors.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Resin-modified glass ionomer cement
Resin-modified glass ionomer cement is used to attach the fixed orthodontic brackets (brace) to the teeth.
Other: Resin-modified glass ionomer cement
This material contains fluoride
Other Names:
  • Brand name: Fuji Ortho
ACTIVE_COMPARATOR: Composite resin
Composite resin is used to attach fixed orthodontic brackets (brace)to the teeth.
Other: Composite resin
This material does not include fluoride
Other Names:
  • Brand name: Transbond

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence and severity of demineralised white lesions on the teeth
Time Frame: Assessed the day the fixed orthodontic appliance is removed
Demineralisation will be assessed from standardised colour images of the upper and lower incisors and canines taken pre-treatment and immediately post-debond
Assessed the day the fixed orthodontic appliance is removed

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of orthodontic bracket failure
Time Frame: Assessed the day the fixed orthodontic appliance is removed
All first time bond/band failures will be recorded at each treatment visit and dated in each subject's data collection form for subsequent failure rate assessment and survival analyses
Assessed the day the fixed orthodontic appliance is removed

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Investigators

  • Principal Investigator: Philip E Benson, PhD, University of Sheffield

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (ACTUAL)

December 1, 2013

Study Completion (ACTUAL)

December 31, 2017

Study Registration Dates

First Submitted

August 16, 2013

First Submitted That Met QC Criteria

August 16, 2013

First Posted (ESTIMATE)

August 20, 2013

Study Record Updates

Last Update Posted (ACTUAL)

January 26, 2018

Last Update Submitted That Met QC Criteria

January 24, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STH14372

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

May share if suitably anonymised

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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