Study of the Success and Survival of Dental Composite Restorations Being Repaired Instead of Being Replaced
NCT ID: NCT02046109
Last Updated: 2016-06-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2014-09-30
2017-12-31
Brief Summary
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It is hypothesized that both treatment will have comparable success rate.
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Detailed Description
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Patients recruited into the study will be randomly assigned to one of two treatment groups. Subjects allocated to Group 1 will have their defective restoration completely replaced while subjects allocated to Group 2 will have their defective restoration repaired.
The success of the treatments will be assessed immediately following the intervention (baseline) and 12 months later.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Repair
Subjects in the Repair group will be given a local anesthetic only if required (i.e. for restorations extending gingivally or on exposed dentin surface) as per usual clinical protocol. The existing restoration will not be removed. The surface of the existing restoration will be roughened with a Brasseler 8856 bur without extending to the surrounding enamel (except is the defect being repaired is adjacent to enamel). No accessory groves/pits for retention will be prepared. To repair the restoration, the surface will be etched using 35% phosphoric acid, and then 3M ESPE Scotchbond Universal Adhesive System followed by 3M ESPE Filtek Supreme Ultra Universal Restorative composite will be used as per the manufacturer's instructions.
Repair
Replace
Subjects in the Replace group will be given local anesthetic (an injection of 2% lidocaine with 1:100 000 epinephrine). The type of injection and dosage of anesthetics will be dependent on the tooth being treated, and will follow the usual protocol used in the Dalhousie Dentistry undergraduate clinics. The existing composite restoration will then be removed and the peripheral enamel beveled if not already beveled. To restore the tooth, the surface will be etched using 35% phosphoric acid, and then 3M ESPE Scotchbond Universal Adhesive System followed by 3M ESPE Filtek Supreme Ultra Universal Restorative composite will be used as per the manufacturer's instructions.
Replace
Interventions
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Repair
Replace
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age 18 and over
* Capable of providing informed consent
* Asymptomatic permanent teeth with class III, IV, V or veneer composite restorations on the facial/buccal surface, requiring treatment (e.g. stain, chipping or color discrepancy).
* Restoration must present with a portion (mesial, distal, gingival or occlusal) that can be completely retained to allow repair.
Exclusion Criteria
* Teeth with active caries
* Teeth with multiple overlapping composite restorations
* Patients with uncontrolled periodontal disease
* Restorations smaller than 3mm diameter
18 Years
ALL
No
Sponsors
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Dalhousie University
OTHER
Responsible Party
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Pierre-Luc Michaud
Assistant Professor
Locations
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Dalhousie University Faculty of Dentistry
Halifax, Nova Scotia, Canada
Countries
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Related Links
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Dalhousie University Faculty of Dentistry Web Site
Other Identifiers
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DalDent-2014-01
Identifier Type: -
Identifier Source: org_study_id
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