RMGI v Composite for Orthodontic Bonding
Resin-modified Glass Ionomer or Composite for Orthodontic Bonding? - a Multi-centre, Randomised, Single Blinded Clinical Trial
1 other identifier
interventional
210
2 countries
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2009
Longer than P75 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 16, 2013
CompletedFirst Posted
Study publicly available on registry
August 20, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2017
CompletedJanuary 26, 2018
January 1, 2018
4.8 years
August 16, 2013
January 24, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Assessed the day the fixed orthodontic appliance is removed
Secondary Outcomes (1)
The incidence of orthodontic bracket failure
Assessed the day the fixed orthodontic appliance is removed
Study Arms (2)
Resin-modified glass ionomer cement
EXPERIMENTALResin-modified glass ionomer cement is used to attach the fixed orthodontic brackets (brace) to the teeth.
Composite resin
ACTIVE COMPARATORComposite resin is used to attach fixed orthodontic brackets (brace)to the teeth.
Interventions
This material contains fluoride
This material does not include fluoride
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Cork Dental Hospital and School
Cork, Ireland
Hightown Orthodontics
Crewe, Cheshire, United Kingdom
Inline Orthodontics
Stevenage, Hertfordshire, SG1 1DU, United Kingdom
Charles Clifford Dental Hospital
Sheffield, South Yorkshire, S10 2TA, United Kingdom
The Orthodontic Centre
Sheffield, South Yorkshire, S10, United Kingdom
Related Publications (1)
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.
PMID: 30591153DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Philip E Benson, PhD
University of Sheffield
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 16, 2013
First Posted
August 20, 2013
Study Start
February 1, 2009
Primary Completion
December 1, 2013
Study Completion
December 31, 2017
Last Updated
January 26, 2018
Record last verified: 2018-01