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

This study is currently recruiting participants.

Verified September 2012 by University of North Carolina, Chapel Hill

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: September 4, 2012

Last verified: September 2012

History of Changes

Purpose

This randomized clinical trial will evaluate 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 will be OptiBond FL, a "traditional" etch/prime/bond adhesive with documented clinical performance. Eighty non-carious Class V cervical lesions will be divided into two groups to be treated with either OptiBond XTR or OptiBond FL. Both adhesives will be applied strictly according to the manufacturer's directions. Herculite Ultra, a nano-hybrid resin-based composite, will be 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:	January 2013 (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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01464996

Contacts

Contact: André V Ritter, DDS, MS	(919)843-6356	rittera@dentistry.unc.edu
Contact: Shannon Tate	(919_966-2770	Shannon_Tate@dentistry.unc.edu

Locations

United States, North Carolina
University of North Carolina at Chapel Hill School of Dentistry	Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: André V Ritter, DDS, MS 919-843-6356 rittera@dentistry.unc.edu
Contact: Shannon Tate (919)966-2770 Shannon_Tate@dentistry.unc.edu
Principal Investigator: André V Ritter, DDS, MS
Sub-Investigator: Harald O Heymann, DDS, MEd
Sub-Investigator: Edward J Swift, Jr, DMD, MS
Sub-Investigator: John R Sturdevant, DDS
Sub-Investigator: Lee Boushell, DDS, MS

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:	September 4, 2012
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 June 18, 2013

To Top