RMGI v Composite for Orthodontic Bonding

Malocclusion Clinical Trial

Official title:

Resin-modified Glass Ionomer or Composite for Orthodontic Bonding? - a Multi-centre, Randomised, Single Blinded Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01925924
• Other study ID #: STH14372
• Status: Completed
• Phase: N/A
• First received: August 16, 2013
• Last updated: January 24, 2018
• Start date: February 2009
• Est. completion date: December 31, 2017

Study information

• Verified date: January 2018
• Source: Sheffield Teaching Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: December 31, 2017
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Malocclusion

Intervention

Other:
• Resin-modified glass ionomer cement
This material contains fluoride
• Composite resin
This material does not include fluoride

Locations

Country	Name	City	State
Ireland	Cork Dental Hospital and School	Cork
United Kingdom	Hightown Orthodontics	Crewe	Cheshire
United Kingdom	Charles Clifford Dental Hospital	Sheffield	South Yorkshire
United Kingdom	The Orthodontic Centre	Sheffield	South Yorkshire
United Kingdom	Inline Orthodontics	Stevenage	Hertfordshire

Sponsors (1)

Lead Sponsor	Collaborator
Sheffield Teaching Hospitals NHS Foundation Trust

Countries where clinical trial is conducted

Ireland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Assessed the day the fixed orthodontic appliance is removed