RMGI v Composite for Orthodontic Bonding
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|ClinicalTrials.gov Identifier: NCT01925924|
Recruitment Status : Completed
First Posted : August 20, 2013
Last Update Posted : January 26, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Malocclusion||Other: Resin-modified glass ionomer cement Other: Composite resin||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||210 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Resin-modified Glass Ionomer or Composite for Orthodontic Bonding? - a Multi-centre, Randomised, Single Blinded Clinical Trial|
|Study Start Date :||February 2009|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 31, 2017|
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 Name: 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 Name: Brand name: Transbond
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01925924
|Cork Dental Hospital and School|
|Crewe, Cheshire, United Kingdom|
|Stevenage, Hertfordshire, United Kingdom, SG1 1DU|
|Charles Clifford Dental Hospital|
|Sheffield, South Yorkshire, United Kingdom, S10 2TA|
|The Orthodontic Centre|
|Sheffield, South Yorkshire, United Kingdom, S10|
|Principal Investigator:||Philip E Benson, PhD||University of Sheffield|