NCT01464996

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2011

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 4, 2011

Completed
27 days until next milestone

Study Start

First participant enrolled

December 1, 2011

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

July 27, 2015

Completed
Last Updated

July 27, 2015

Status Verified

July 1, 2015

Enrollment Period

2.2 years

First QC Date

October 25, 2011

Results QC Date

June 19, 2015

Last Update Submit

July 24, 2015

Conditions

Composite RestorationsTooth Lesions

Keywords

non-carious cervical lesionsbonded restorationscompositesadhesives

Outcome Measures

Primary Outcomes (1)

  • Retention

    Overall retention of restorations

    6 and 18 months post-baseline

Secondary Outcomes (6)

  • Color Match

    18 months post-baseline

  • Cavosurface Margin Discoloration

    18 months post-baseline

  • Secondary Caries

    18 months post-baseline

  • Anatomic Form

    18 months post-baseline

  • Marginal Adaptation and/or Integrity

    18 months post-baseline

  • +1 more secondary outcomes

Study Arms (2)

Adhesive OptiBond XTR

EXPERIMENTAL

Adhesive OptiBond XTR will include composite restorations placed using the dental adhesive OptiBond XTR.

Procedure: Adhesive: OptiBond XTR; Composite: Herculite Ultra

Adhesive OptiBond FL

ACTIVE COMPARATOR

Adhesive OptiBond FL will include composite restorations placed using the dental adhesive OptiBond FL.

Procedure: Adhesive: OptiBond FL; Composite: Herculite Ultra

Interventions

Adhesive: OptiBond XTR; Composite: Herculite UltraPROCEDURE

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

Adhesive OptiBond XTR
Adhesive: OptiBond FL; Composite: Herculite UltraPROCEDURE

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

Adhesive OptiBond FL

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina at Chapel Hill School of Dentistry

Chapel Hill, North Carolina, 27599, United States

Location

Results Point of Contact

Title
Dr. Andre Ritter, Professor and Chair
Organization
University of North Carolina at Chapel Hill School of Dentistry
andre_ritter@unc.edu
919-537-3987

Study Officials

  • André V Ritter, DDS, MS

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor UNC School of Dentistry

Study Record Dates

First Submitted

October 25, 2011

First Posted

November 4, 2011

Study Start

December 1, 2011

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

July 27, 2015

Results First Posted

July 27, 2015

Record last verified: 2015-07

Locations

US(1)