Study of the Success and Survival of Dental Composite Restorations Being Repaired Instead of Being Replaced

NCT02046109 | Withdrawn

• 1 other identifier: DalDent-2014-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Failing Dental Composite Restorations

Keywords

Repair; Replace; Composite; restoration; failing dental restoration; filling; dental; dentistry

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Survival

  12-month

Study Arms (2)

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.

Procedure: Repair

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.

Procedure: Replace

Interventions

Repair PROCEDURE

Also known as: Scotchbond Universal, Filtek Supreme

Repair

Replace PROCEDURE

Also known as: Scotchbond Universal, Filtek Supreme

Replace

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of the Dalhousie University Dental Clinic who are:
• 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.

You may not qualify if:

• Patients with contra-indications for regular dental treatment based on their medical history
• Teeth with active caries
• Teeth with multiple overlapping composite restorations
• Patients with uncontrolled periodontal disease
• Restorations smaller than 3mm diameter

Sponsors & Collaborators

• Dalhousie University: lead

Study Sites (1)

Dalhousie University Faculty of Dentistry

Halifax, Nova Scotia, B3H 4R2, Canada

Location

Related Links

• Dalhousie University Faculty of Dentistry Web Site

MeSH Terms

Interventions

Wound Healing; Filtek Supreme

Intervention Hierarchy (Ancestors)

Regeneration; Biological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 23, 2014
• First Posted: January 27, 2014
• Study Start: September 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2017
• Last Updated: June 22, 2016

Record last verified: 2016-06

Locations

CA (1)