RMGI v Composite for Orthodontic Bonding
Primary Purpose
Malocclusion
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Resin-modified glass ionomer cement
Composite resin
Sponsored by
About this trial
This is an interventional prevention trial for Malocclusion focused on measuring Dental cements, Orthodontic adhesives, Glass ionomer cement, Tooth demineralization
Eligibility Criteria
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.
Sites / Locations
- Cork Dental Hospital and School
- Hightown Orthodontics
- Inline Orthodontics
- Charles Clifford Dental Hospital
- The Orthodontic Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Resin-modified glass ionomer cement
Composite resin
Arm Description
Resin-modified glass ionomer cement is used to attach the fixed orthodontic brackets (brace) to the teeth.
Composite resin is used to attach fixed orthodontic brackets (brace)to the teeth.
Outcomes
Primary Outcome Measures
Incidence and severity of demineralised white lesions on the teeth
Demineralisation will be assessed from standardised colour images of the upper and lower incisors and canines taken pre-treatment and immediately post-debond
Secondary Outcome Measures
The incidence of orthodontic bracket failure
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
Full Information
NCT ID
NCT01925924
First Posted
August 16, 2013
Last Updated
January 24, 2018
Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT01925924
Brief Title
RMGI v Composite for Orthodontic Bonding
Official Title
Resin-modified Glass Ionomer or Composite for Orthodontic Bonding? - a Multi-centre, Randomised, Single Blinded Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malocclusion
Keywords
Dental cements, Orthodontic adhesives, Glass ionomer cement, Tooth demineralization
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
210 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Resin-modified glass ionomer cement
Arm Type
Experimental
Arm Description
Resin-modified glass ionomer cement is used to attach the fixed orthodontic brackets (brace) to the teeth.
Arm Title
Composite resin
Arm Type
Active Comparator
Arm Description
Composite resin is used to attach fixed orthodontic brackets (brace)to the teeth.
Intervention Type
Other
Intervention Name(s)
Resin-modified glass ionomer cement
Other Intervention Name(s)
Brand name: Fuji Ortho
Intervention Description
This material contains fluoride
Intervention Type
Other
Intervention Name(s)
Composite resin
Other Intervention Name(s)
Brand name: Transbond
Intervention Description
This material does not include fluoride
Primary Outcome Measure Information:
Title
Incidence and severity of demineralised white lesions on the teeth
Description
Demineralisation will be assessed from standardised colour images of the upper and lower incisors and canines taken pre-treatment and immediately post-debond
Time Frame
Assessed the day the fixed orthodontic appliance is removed
Secondary Outcome Measure Information:
Title
The incidence of orthodontic bracket failure
Description
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
Time Frame
Assessed the day the fixed orthodontic appliance is removed
10. Eligibility
Sex
All
Minimum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip E Benson, PhD
Organizational Affiliation
University of Sheffield
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cork Dental Hospital and School
City
Cork
Country
Ireland
Facility Name
Hightown Orthodontics
City
Crewe
State/Province
Cheshire
Country
United Kingdom
Facility Name
Inline Orthodontics
City
Stevenage
State/Province
Hertfordshire
ZIP/Postal Code
SG1 1DU
Country
United Kingdom
Facility Name
Charles Clifford Dental Hospital
City
Sheffield
State/Province
South Yorkshire
ZIP/Postal Code
S10 2TA
Country
United Kingdom
Facility Name
The Orthodontic Centre
City
Sheffield
State/Province
South Yorkshire
ZIP/Postal Code
S10
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
May share if suitably anonymised
Citations:
PubMed Identifier
30591153
Citation
Benson PE, Alexander-Abt J, Cotter S, Dyer FMV, Fenesha F, Patel A, Campbell C, Crowley N, Millett DT. Resin-modified glass ionomer cement vs composite for orthodontic bonding: A multicenter, single-blind, randomized controlled trial. Am J Orthod Dentofacial Orthop. 2019 Jan;155(1):10-18. doi: 10.1016/j.ajodo.2018.09.005.
Results Reference
derived
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RMGI v Composite for Orthodontic Bonding
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