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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Kerr Corporation
Information provided by (Responsible Party):
André V. Ritter, DDS, MS, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01464996
First received: October 25, 2011
Last updated: July 10, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Composite Restorations
Tooth Lesions
Procedure: Adhesives: OptiBond XTR Composite: Herculite Ultra
Procedure: Adhesives: OptiBond FL Composite: Herculite Ultra

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Official Title: Clinical Evaluation Of A New Two-Component Self-Etch Universal Adhesive (OptiBond XTR)

Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Change from Baseline in Retention Rates at two time points: 6 months and 18 months [ Time Frame: 6 and 18 months post-baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Color match [ Time Frame: 6 and 18 months post-baseline ] [ Designated as safety issue: No ]
  • Cavosurface margin discoloration [ Time Frame: 6 and 18 months post-baseline ] [ Designated as safety issue: No ]
  • Secondary caries [ Time Frame: 6 and 18 months post-baseline ] [ Designated as safety issue: No ]
  • Anatomic form [ Time Frame: 6 and 18 months post-baseline ] [ Designated as safety issue: No ]
  • Marginal adaptation and/or integrity [ Time Frame: 6 and 18 months post-baseline ] [ Designated as safety issue: No ]
  • Post operative sensitivity [ Time Frame: 6 and 18 months post-baseline ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: December 2011
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Adhesive OptiBond XTR
will include composite restorations placed using the dental adhesive OptiBond XTR.
Procedure: Adhesives: OptiBond XTR Composite: Herculite Ultra
The intervention in Arm 1 (XTR) is a 2-step, self-etching adhesive.
Active Comparator: Adhesive OptiBond FL
will include composite restorations placed using the dental adhesive OptibOnd FL.
Procedure: Adhesives: OptiBond FL Composite: Herculite Ultra
Arm 2 (FL) is a 3-step, etch-and-rinse adhesive.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects needing restoration of NCCLs (these include some cases where the patient has hypersensitivity and a restoration is indicated)
  • Subjects with age range 18-80 years old
  • Teeth with normal occlusion relationships

Exclusion Criteria:

  • Subjects with fewer than 20 teeth
  • Subjects with poor oral hygiene and/or uncontrolled periodontal disease
  • Teeth with NCCLs with mechanical undercuts
  • Subjects with known allergies to HEMA or resin-based materials. The materials to be used are HEMA and/or resin-based materials.
  • Subjects with medical conditions that contraindicate dental treatment.
  • Subjects with xerostomia. Xerostomia is a condition where there is a decrease salivary flow (dry mouth). Decrease salivary flow is a known factor that affects the long-term prognosis of dental restorations, and would be a confounder.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01464996

Locations
United States, North Carolina
University of North Carolina at Chapel Hill School of Dentistry
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Kerr Corporation
Investigators
Principal Investigator: André V Ritter, DDS, MS University of North Carolina, Chapel Hill
  More Information

No publications provided

Responsible Party: André V. Ritter, DDS, MS, Professor UNC School of Dentistry, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01464996     History of Changes
Other Study ID Numbers: Kerr-XTR-11
Study First Received: October 25, 2011
Last Updated: July 10, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
non-carious cervical lesions
bonded restorations
composites
adhesives

ClinicalTrials.gov processed this record on August 28, 2014