This trial is active, not recruiting.

Condition malocclusion
Treatments resin-modified glass ionomer cement, composite resin
Sponsor Sheffield Teaching Hospitals NHS Foundation Trust
Start date February 2009
End date December 2013
Trial size 210 participants
Trial identifier NCT01925924, STH14372


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose prevention
Resin-modified glass ionomer cement is used to attach the fixed orthodontic brackets (brace) to the teeth.
resin-modified glass ionomer cement Brand name: Fuji Ortho
This material contains fluoride
(Active Comparator)
Composite resin is used to attach fixed orthodontic brackets (brace)to the teeth.
composite resin Brand name: Transbond
This material does not include fluoride

Primary Outcomes

Incidence and severity of demineralised white lesions on the teeth
time frame: Assessed the day the fixed orthodontic appliance is removed

Secondary Outcomes

The incidence of orthodontic bracket failure
time frame: Assessed the day the fixed orthodontic appliance is removed

Eligibility Criteria

Male or female participants at least 11 years old.

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.

Additional Information

Official title Resin-modified Glass Ionomer or Composite for Orthodontic Bonding? - a Multi-centre, Randomised, Single Blinded Clinical Trial
Principal investigator Philip E Benson, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Sheffield Teaching Hospitals NHS Foundation Trust.