Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01464996
Recruitment Status : Completed
First Posted : November 4, 2011
Results First Posted : July 27, 2015
Last Update Posted : July 27, 2015
Sponsor:
Collaborator:
Kerr Corporation
Information provided by (Responsible Party):
André V. Ritter, DDS, MS, University of North Carolina, Chapel Hill

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant)
Conditions Composite Restorations
Tooth Lesions
Interventions Procedure: Adhesive: OptiBond XTR; Composite: Herculite Ultra
Procedure: Adhesive: OptiBond FL; Composite: Herculite Ultra
Enrollment 24
Recruitment Details  
Pre-assignment Details Twenty six participants were screened and satisfied inclusion criteria, but only 24 were enrolled.
Arm/Group Title All Study Participants
Hide Arm/Group Description

Will include composite restorations placed using both the dental adhesive OptiBond XTR and OptiBond FL.

Participants were randomized to receive either type of intervention

Period Title: Overall Study
Started 24
OptiBond XTR 23
OptiBond FL 24
Completed 24
Not Completed 0
Arm/Group Title All Study Participants
Hide Arm/Group Description Will include composite restorations placed using both dental adhesives OptiBond XTR and OptiBond FL.
Overall Number of Baseline Participants 24
Hide Baseline Analysis Population Description
There were 24 participants in the study. The 24 participants received 83 restorations. As per protocol, participants received restorations from both arms, hence total number of study participants should not be the sum of the number of participants for each arm.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants
56  (20)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
Female
20
  83.3%
Male
4
  16.7%
Number of Restorations, Categorical  
Measure Type: Number
Unit of measure:  Number of restorations, unit
Number Analyzed 24 participants
OptiBond XTR 41
OptiBond FL 42
Stressful Occlusion, Categorical  
Measure Type: Number
Unit of measure:  Number of teeth with stressful occlusion
Number Analyzed 24 participants
OptiBond XTR 20
OptiBond FL 20
1.Primary Outcome
Title Retention
Hide Description Overall retention of restorations
Time Frame 6 and 18 months post-baseline
Hide Outcome Measure Data
Hide Analysis Population Description
what is reported here is the retention rate using the restoration as the unit of analysis
Arm/Group Title Adhesive OptiBond XTR Adhesive OptiBond FL
Hide Arm/Group Description:

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

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

will include composite restorations placed using the dental adhesive OptibOnd FL.

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

Overall Number of Participants Analyzed 23 24
Overall Number of Units Analyzed
Type of Units Analyzed: Restorations
41 42
Measure Type: Number
Unit of Measure: percentage of restorations
6 months 100 100
18 months 100 97
2.Secondary Outcome
Title Color Match
Hide Description Percentage of restorations that scored alfa. Restoration matches adjacent tooth structure in color, shade and translucency.
Time Frame 18 months post-baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Adhesive OptiBond XTR Adhesive OptiBond FL
Hide Arm/Group Description:

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

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

will include composite restorations placed using the dental adhesive OptibOnd FL.

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

Overall Number of Participants Analyzed 23 24
Overall Number of Units Analyzed
Type of Units Analyzed: Restorations
41 42
Measure Type: Number
Unit of Measure: % of restorations with alfa scores
89 76
3.Secondary Outcome
Title Cavosurface Margin Discoloration
Hide Description Percentage of restorations scoring alfa. No discoloration is present anywhere on the margin between the restoration and the tooth structure.
Time Frame 18 months post-baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Adhesive OptiBond XTR Adhesive OptiBond FL
Hide Arm/Group Description:

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

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

will include composite restorations placed using the dental adhesive OptibOnd FL.

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

Overall Number of Participants Analyzed 23 24
Overall Number of Units Analyzed
Type of Units Analyzed: Restorations
41 42
Measure Type: Number
Unit of Measure: % of restorations with alfa scores
89 92
4.Secondary Outcome
Title Secondary Caries
Hide Description Percentage of restorations with alfa scores. Absence of caries is evidenced by softness, opacity, or etching at the margin of the restoration.
Time Frame 18 months post-baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Adhesive OptiBond XTR Adhesive OptiBond FL
Hide Arm/Group Description:

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

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

will include composite restorations placed using the dental adhesive OptibOnd FL.

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

Overall Number of Participants Analyzed 23 24
Overall Number of Units Analyzed
Type of Units Analyzed: Restorations
41 42
Measure Type: Number
Unit of Measure: % of restorations with alfa scores
100 100
5.Secondary Outcome
Title Anatomic Form
Hide Description Percentage of restorations with alfa scores. Restoration is continuous with existing anatomic form.
Time Frame 18 months post-baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Adhesive OptiBond XTR Adhesive OptiBond FL
Hide Arm/Group Description:

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

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

will include composite restorations placed using the dental adhesive OptibOnd FL.

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

Overall Number of Participants Analyzed 23 24
Overall Number of Units Analyzed
Type of Units Analyzed: Restorations
41 42
Measure Type: Number
Unit of Measure: % of restorations with alfa scores
97 92
6.Secondary Outcome
Title Marginal Adaptation and/or Integrity
Hide Description Percentage of restorations with alfa scores. No discoloration is present anywhere on the margin between the restoration and the tooth structure.
Time Frame 18 months post-baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Adhesive OptiBond XTR Adhesive OptiBond FL
Hide Arm/Group Description:

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

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

will include composite restorations placed using the dental adhesive OptibOnd FL.

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

Overall Number of Participants Analyzed 23 24
Overall Number of Units Analyzed
Type of Units Analyzed: Restorations
41 42
Measure Type: Number
Unit of Measure: % of restorations with alfa scores
97 89
7.Secondary Outcome
Title Post Operative Sensitivity
Hide Description Percentage of restorations with alfa scores. No sensitivity.
Time Frame 18 months post-baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Adhesive OptiBond XTR Adhesive OptiBond FL
Hide Arm/Group Description:

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

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

will include composite restorations placed using the dental adhesive OptibOnd FL.

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

Overall Number of Participants Analyzed 23 24
Overall Number of Units Analyzed
Type of Units Analyzed: Re
41 42
Measure Type: Number
Unit of Measure: % of restorations with alfa scores
100 100
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Adhesive OptiBond XTR Adhesive OptiBond FL
Hide Arm/Group Description

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

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

will include composite restorations placed using the dental adhesive OptibOnd FL.

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

All-Cause Mortality
Adhesive OptiBond XTR Adhesive OptiBond FL
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Adhesive OptiBond XTR Adhesive OptiBond FL
Affected / at Risk (%) Affected / at Risk (%)
Total   0/23 (0.00%)   0/24 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Adhesive OptiBond XTR Adhesive OptiBond FL
Affected / at Risk (%) Affected / at Risk (%)
Total   0/23 (0.00%)   0/24 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Andre Ritter, Professor and Chair
Organization: University of North Carolina at Chapel Hill School of Dentistry
Phone: 919-537-3987
EMail: andre_ritter@unc.edu
Layout table for additonal information
Responsible Party: André V. Ritter, DDS, MS, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01464996    
Other Study ID Numbers: Kerr-XTR-11
First Submitted: October 25, 2011
First Posted: November 4, 2011
Results First Submitted: June 19, 2015
Results First Posted: July 27, 2015
Last Update Posted: July 27, 2015