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RMGI v Composite for Orthodontic Bonding

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Sheffield Teaching Hospitals NHS Foundation Trust
Sponsor:
Collaborator:
Sheffield Hospitals Charitable Trust
Information provided by (Responsible Party):
Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01925924
First received: August 16, 2013
Last updated: NA
Last verified: August 2013
History: No changes posted
  Purpose

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 Intervention
Malocclusion
Other: Resin-modified glass ionomer cement
Other: Composite resin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Resin-modified Glass Ionomer or Composite for Orthodontic Bonding? - a Multi-centre, Randomised, Single Blinded Clinical Trial

Resource links provided by NLM:


Further study details as provided by Sheffield Teaching Hospitals NHS Foundation Trust:

Primary Outcome Measures:
  • Incidence and severity of demineralised white lesions on the teeth [ Time Frame: Assessed the day the fixed orthodontic appliance is removed ] [ Designated as safety issue: No ]
    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 [ Time Frame: Assessed the day the fixed orthodontic appliance is removed ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 210
Study Start Date: February 2009
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   11 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01925924

Contacts
Contact: Philip E Benson, PhD +441142717889 p.benson@sheffield.ac.uk
Contact: Pamela Barragry +441142717809 pamela.barragry@sth.nhs.uk

Locations
Ireland
Cork Dental Hospital and School Active, not recruiting
Cork, Ireland
United Kingdom
Hightown Orthodontics Recruiting
Crewe, Cheshire, United Kingdom
Sub-Investigator: Chris Lowe         
Inline Orthodontics Active, not recruiting
Stevenage, Hertfordshire, United Kingdom, SG1 1DU
Charles Clifford Dental Hospital Recruiting
Sheffield, South Yorkshire, United Kingdom, S10 2TA
Principal Investigator: Philip E Benson, PhD         
The Orthodontic Centre Recruiting
Sheffield, South Yorkshire, United Kingdom, S10
Principal Investigator: Fiona Dyer, BDS         
Sponsors and Collaborators
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield Hospitals Charitable Trust
Investigators
Principal Investigator: Philip E Benson, PhD University of Sheffield
  More Information

No publications provided

Responsible Party: Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01925924     History of Changes
Other Study ID Numbers: STH14372
Study First Received: August 16, 2013
Last Updated: August 16, 2013
Health Authority: United Kingdom: National Health Service
United Kingdom: Research Ethics Committee

Keywords provided by Sheffield Teaching Hospitals NHS Foundation Trust:
Dental cements
Orthodontic adhesives
Glass ionomer cement
Tooth demineralization

Additional relevant MeSH terms:
Malocclusion
Stomatognathic Diseases
Tooth Diseases

ClinicalTrials.gov processed this record on November 20, 2014