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Clinical Evaluation Of A New Two-Component Self-Etch Universal Adhesive

NCT01464996 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2015-07-27

Study results available
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Summary

This randomized clinical trial evaluates the clinical performance of a new two-component self-etch universal adhesive, OptiBond XTR, when applied in non-carious Class V cervical lesions without macromechanical retention (retentive grooves or bevels). The control material is OptiBond FL, a "traditional" etch/prime/bond adhesive with documented clinical performance. Eighty non-carious Class V cervical lesions are divided into two groups to be treated with either OptiBond XTR or OptiBond FL. Both adhesives are applied strictly according to the manufacturer's directions. Herculite Ultra, a nano-hybrid resin-based composite, is used as the restorative material with both adhesives. The restorations will be evaluated at insertion (baseline), 6 months, and 18 months. An optional three-year recall evaluation is also proposed. The investigators hypothesize that both adhesives will have comparable performance.

Conditions

  • Composite Restorations
  • Tooth Lesions

Interventions

PROCEDURE

Adhesive: OptiBond XTR; Composite: Herculite Ultra

The intervention in Arm 1 (Adhesive: OptiBond XTR; Composite: Herculite Ultra) is a 2-step, self-etching adhesive.

PROCEDURE

Adhesive: OptiBond FL; Composite: Herculite Ultra

Arm 2 (Adhesive: OptiBond FL; Composite: Herculite Ultra) is a 3-step, etch-and-rinse adhesive.

Sponsors & Collaborators

  • Kerr Corporation

    collaborator INDUSTRY

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • André V Ritter, DDS, MS · University of North Carolina, Chapel Hill

Study Design

Allocation
RANDOMIZED
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01464996 on ClinicalTrials.gov