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Because of logistic problems, we could not recruit any patient.
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The objective of this trial is to compare the success (as assessed by a pre-defined set of outcome) of failing composite resin restorations that are repaired using diamond bur induced surface abrasion, to those that are completely replaced.
It is hypothesized that both treatment will have comparable success rate.
This study is a single-blind randomized non-inferiority trial using parallel groups.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Repair | Experimental | 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. |
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| Replace | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Repair | Procedure |
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| Measure | Description | Time Frame |
|---|---|---|
| Success rate | The primary outcome will be the success of the restoration. This will be assessed using the modified U.S. Public Health Service (USPHS) criteria as first described by Cvar and Ryge (1971) and adapted by Wilson et al (2002). | 12-month |
| Measure | Description | Time Frame |
|---|---|---|
| Survival | 12-month |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dalhousie University Faculty of Dentistry | Halifax | Nova Scotia | B3H 4R2 | Canada |
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| Label | URL |
|---|---|
| Dalhousie University Faculty of Dentistry Web Site | View source |
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| ID | Term |
|---|---|
| D014945 | Wound Healing |
| C474035 | Filtek Supreme |
| ID | Term |
|---|---|
| D012038 | Regeneration |
| D001686 | Biological Phenomena |
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| Replace |
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