Trial Outcomes & Findings for Clinical Evaluation Of A New Two-Component Self-Etch Universal Adhesive (NCT NCT01464996)

NCT ID: NCT01464996

Last Updated: 2015-07-27

Results Overview

Overall retention of restorations

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 24 participants
• Primary outcome timeframe: 6 and 18 months post-baseline
• Results posted on: 2015-07-27

Participant Flow

Twenty six participants were screened and satisfied inclusion criteria, but only 24 were enrolled.

Participant milestones

Measure	All Study Participants Will include composite restorations placed using both the dental adhesive OptiBond XTR and OptiBond FL. Participants were randomized to receive either type of intervention
Overall Study STARTED	24
Overall Study OptiBond XTR	23
Overall Study OptiBond FL	24
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	All Study Participants n=24 Participants Will include composite restorations placed using both dental adhesives OptiBond XTR and OptiBond FL.
Age, Continuous	56 Years STANDARD_DEVIATION 20 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Number of Restorations, Categorical OptiBond XTR	41 number of restorations, unit n=5 Participants
Number of Restorations, Categorical OptiBond FL	42 number of restorations, unit n=5 Participants
Stressful Occlusion, Categorical OptiBond XTR	20 Number of teeth with stressful occlusion n=5 Participants
Stressful Occlusion, Categorical OptiBond FL	20 Number of teeth with stressful occlusion n=5 Participants

PRIMARY outcome

Timeframe: 6 and 18 months post-baseline

Population: what is reported here is the retention rate using the restoration as the unit of analysis

Overall retention of restorations

Outcome measures

Measure	Adhesive OptiBond XTR n=41 restorations 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.	Adhesive OptiBond FL n=42 restorations 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.
Retention 6 months	100 percentage of restorations	100 percentage of restorations
Retention 18 months	100 percentage of restorations	97 percentage of restorations

SECONDARY outcome

Timeframe: 18 months post-baseline

Percentage of restorations that scored alfa. Restoration matches adjacent tooth structure in color, shade and translucency.

Outcome measures

Measure	Adhesive OptiBond XTR n=41 restorations 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.	Adhesive OptiBond FL n=42 restorations 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.
Color Match	89 % of restorations with alfa scores	76 % of restorations with alfa scores

SECONDARY outcome

Timeframe: 18 months post-baseline

Percentage of restorations scoring alfa. No discoloration is present anywhere on the margin between the restoration and the tooth structure.

Outcome measures

Measure	Adhesive OptiBond XTR n=41 restorations 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.	Adhesive OptiBond FL n=42 restorations 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.
Cavosurface Margin Discoloration	89 % of restorations with alfa scores	92 % of restorations with alfa scores

SECONDARY outcome

Timeframe: 18 months post-baseline

Percentage of restorations with alfa scores. Absence of caries is evidenced by softness, opacity, or etching at the margin of the restoration.

Outcome measures

Measure	Adhesive OptiBond XTR n=41 restorations 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.	Adhesive OptiBond FL n=42 restorations 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.
Secondary Caries	100 % of restorations with alfa scores	100 % of restorations with alfa scores

SECONDARY outcome

Timeframe: 18 months post-baseline

Percentage of restorations with alfa scores. Restoration is continuous with existing anatomic form.

Outcome measures

Measure	Adhesive OptiBond XTR n=41 restorations 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.	Adhesive OptiBond FL n=42 restorations 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.
Anatomic Form	97 % of restorations with alfa scores	92 % of restorations with alfa scores

SECONDARY outcome

Timeframe: 18 months post-baseline

Percentage of restorations with alfa scores. No discoloration is present anywhere on the margin between the restoration and the tooth structure.

Outcome measures

Measure	Adhesive OptiBond XTR n=41 restorations 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.	Adhesive OptiBond FL n=42 restorations 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.
Marginal Adaptation and/or Integrity	97 % of restorations with alfa scores	89 % of restorations with alfa scores

SECONDARY outcome

Timeframe: 18 months post-baseline

Percentage of restorations with alfa scores. No sensitivity.

Outcome measures

Measure	Adhesive OptiBond XTR n=41 re 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.	Adhesive OptiBond FL n=42 re 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.
Post Operative Sensitivity	100 % of restorations with alfa scores	100 % of restorations with alfa scores

Adverse Events

Adhesive OptiBond XTR

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adhesive OptiBond FL

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Andre Ritter, Professor and Chair

University of North Carolina at Chapel Hill School of Dentistry

Phone: 919-537-3987

Email: andre_ritter@unc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place