Trial Outcomes & Findings for Evaluation of a "Flash-free" Adhesive Resin for Orthodontic Bracket Bonding (NCT NCT02030002)

NCT ID: NCT02030002

Last Updated: 2021-01-12

Results Overview

The time taken to bond each tooth was timed to the nearest second using a digital stopwatch. Timing was started after enamel surface preparation and stopped before light curing. Outcome reported in seconds.

Recruitment status

COMPLETED

Study phase

Target enrollment

49 participants

Primary outcome timeframe

At appliance placement, 30 minutes

Results posted on

2021-01-12

Participant Flow

Participant milestones

Participant milestones
Measure	All Participants This is a single-arm, split-mouth study. Participants receive both treatments at the same time. Participants had APC Flash-Free Adhesive Appliance System on one side of their mouth and APCII Adhesive Appliance System on the other side. The side allocation was randomized as follows. A randomization scheme with equal distribution of the two side allocations was generated using the online randomization tool at http://www.graphpad.com/quickcalcs. Allocation concealment was achieved with sequentially numbered, opaque sealed envelopes (SNOSE) containing the side allocation of the adhesives, which were prepared before the trial. An independent third party was responsible for opening the next envelope in sequence and implementing the randomization process.
Enrollment STARTED	49
Enrollment COMPLETED	44
Enrollment NOT COMPLETED	5
APC Flash-Free Adhesive Coated Appliance STARTED	44
APC Flash-Free Adhesive Coated Appliance COMPLETED	44
APC Flash-Free Adhesive Coated Appliance NOT COMPLETED	0
APC II Adhesive Coated Appliance System STARTED	44
APC II Adhesive Coated Appliance System COMPLETED	44
APC II Adhesive Coated Appliance System NOT COMPLETED	0
Follow-up STARTED	44
Follow-up COMPLETED	42
Follow-up NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	All Participants This is a single-arm, split-mouth study. Participants receive both treatments at the same time. Participants had APC Flash-Free Adhesive Appliance System on one side of their mouth and APCII Adhesive Appliance System on the other side. The side allocation was randomized as follows. A randomization scheme with equal distribution of the two side allocations was generated using the online randomization tool at http://www.graphpad.com/quickcalcs. Allocation concealment was achieved with sequentially numbered, opaque sealed envelopes (SNOSE) containing the side allocation of the adhesives, which were prepared before the trial. An independent third party was responsible for opening the next envelope in sequence and implementing the randomization process.
Enrollment Participant had change in treatment plan and no longer met the inclusion criteria	1
Enrollment Participants signed consent, but enrollment was completed before their treatment began.	4
Follow-up Lost to Follow-up	2

Baseline Characteristics

Evaluation of a "Flash-free" Adhesive Resin for Orthodontic Bracket Bonding

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=45 Participants This is a single-arm study. Participants receive both treatments at the same time. All participants are counted as one group at baseline.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	45 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	19.7 years STANDARD_DEVIATION 9.3 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	45 Participants n=5 Participants
Region of Enrollment United States	45 participants n=5 Participants

PRIMARY outcome

Timeframe: At appliance placement, 30 minutes

Population: All participants who received the treatment are included in this analysis.

Outcome measures

Outcome measures
Measure	APC Flash-Free Adhesive Coated Appliance System n=45 Participants APC Flash-Free Adhesive Coated Appliance System APC Flash-Free Adhesive Coated Appliance System: APC Flash-Free Adhesive Coated Appliance System	APC II Adhesive Coated Appliance System n=45 Participants APC II Adhesive Coated Appliance System APC II Adhesive Coated Appliance System: APC II Adhesive Coated Appliance System
Bonding Time	42.5 seconds Standard Deviation 5.9	67.7 seconds Standard Deviation 5.9

PRIMARY outcome

Timeframe: 1 year post treatment

Population: Of the 45 participants who completed treatment, 43 completed the follow-up period and are included in this analysis.

Bond failure (yes or no) was recorded at standardized appointments at intervals of 4 weeks. Outcome is reported as the cumulative number of failed bracket bonds across all participants at 1 year post-treatment.

Outcome measures

Outcome measures
Measure	APC Flash-Free Adhesive Coated Appliance System n=43 Participants APC Flash-Free Adhesive Coated Appliance System APC Flash-Free Adhesive Coated Appliance System: APC Flash-Free Adhesive Coated Appliance System	APC II Adhesive Coated Appliance System n=43 Participants APC II Adhesive Coated Appliance System APC II Adhesive Coated Appliance System: APC II Adhesive Coated Appliance System
Bond Survival	8 failed bracket bonds	2 failed bracket bonds

PRIMARY outcome

Timeframe: At completion of treatment, 10 minutes.

Population: Of the 45 participants who completed treatment, 43 completed the follow-up period. One additional participant is excluded from this analysis due to a change in treatment plan that made them eligible according to the inclusion/exclusion criteria.

In case of a bond failure, the adhesive remnant index (ARI) was scored. The ARI is a point-based system ranking: 0, no adhesive left on the tooth; 1, less than half of the adhesive left on the tooth; 2, more than half of the adhesive left on the tooth; and 3, all adhesive left on the tooth.

Outcome measures

Outcome measures
Measure	APC Flash-Free Adhesive Coated Appliance System n=42 Participants APC Flash-Free Adhesive Coated Appliance System APC Flash-Free Adhesive Coated Appliance System: APC Flash-Free Adhesive Coated Appliance System	APC II Adhesive Coated Appliance System n=42 Participants APC II Adhesive Coated Appliance System APC II Adhesive Coated Appliance System: APC II Adhesive Coated Appliance System
Amount of Adhesive Remaining on the Tooth Surface After Bracket Debonding	2.53 score on a scale Standard Deviation .36	2.29 score on a scale Standard Deviation .4

PRIMARY outcome

Timeframe: At completion of treatment, 30 minutes.

If adhesive remained after bracket de-bonding, then the time required to remove the remnant adhesive was measured using a digital stop-watch. Outcome is reported in seconds.

Outcome measures

Outcome measures
Measure	APC Flash-Free Adhesive Coated Appliance System n=42 Participants APC Flash-Free Adhesive Coated Appliance System APC Flash-Free Adhesive Coated Appliance System: APC Flash-Free Adhesive Coated Appliance System	APC II Adhesive Coated Appliance System n=42 Participants APC II Adhesive Coated Appliance System APC II Adhesive Coated Appliance System: APC II Adhesive Coated Appliance System
Time Required for Adhesive Remnant Cleanup	167.3 seconds Standard Deviation 63.5	215.1 seconds Standard Deviation 79.8

Adverse Events

APC Flash-Free Adhesive Coated Appliance System

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

APC II Adhesive Coated Appliance System

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

Thorsten Gruenheid

University of Minnesota

Phone: 612-625-3903

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place