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OpenTrials
Completed

NCT Number: NCT01925924

RMGI v Composite for Orthodontic Bonding

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.

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Key information

Conditions

Malocclusion Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

11 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cork Dental Hospital and School, Cork, Ireland

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Resin-modified glass ionomer cement

Other

This material contains fluoride

Other names: Brand name: Fuji Ortho

Composite resin

Other

This material does not include fluoride

Other names: Brand name: Transbond

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2013
Study completion
2017
First posted
Aug 20, 2013
Registry last updated
Jan 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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