Malocclusion
Conditions
Brief summary
The purpose of this study is to compare bonding time, bond survival, amount of adhesive remaining on the tooth surface after bracket debonding, and time required for adhesive remnant cleanup between a new flash-free and a conventional adhesive resin for orthodontic bracket bonding.
Detailed description
Patients presenting for comprehensive orthodontic treatment with fixed appliances at the University of Minnesota, who are willing to participate, will be included in the initial study. Selection criteria will include full permanent dentition through the first molars, teeth with sound, non-carious buccal enamel and no pretreatment with chemical agents such as hydrogen peroxide, and no previous orthodontic treatment with fixed appliances. The patients will have their maxillary incisors, canines, and premolars bonded with ceramic orthodontic brackets pre-coated with a flash-free adhesive resin (Clarity Advanced Brackets APC flash-free, 3M Unitek, Monrovia, CA, USA) on one side and a conventional adhesive resin (Clarity Advanced Brackets APC II, 3M Unitek) on the other side. The side allocation and order of bonding will be randomized for each patient.
Interventions
DEVICEAPC Flash-Free Adhesive Coated Appliance System
APC Flash-Free Adhesive Coated Appliance System
DEVICEAPC II Adhesive Coated Appliance System
APC II Adhesive Coated Appliance System
Sponsors
3M
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Split-mouth
Eligibility
Sex/Gender
ALL
Age
10 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Full permanent dentition including incisors, canines, premolars, and first molars * Teeth with sound, non-carious buccal enamel and no pretreatment with chemical agents such as hydrogen peroxide * No previous orthodontic treatment with fixed appliances
Exclusion criteria
* Mental/emotional/developmental disability * Cleft lip and/or palate, craniofacial anomaly, or syndrome * Obvious oral hygiene issues such as excessive plaque accumulation, gingivitis, and/or pre-existing white spot lesions * Prosthodontic or restored substrate extending on the labial surface of maxillary teeth * Known allergies to any acrylates contained in the study materials
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bonding Time | At appliance placement, 30 minutes | 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. |
| Bond Survival | 1 year post treatment | 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. |
| Amount of Adhesive Remaining on the Tooth Surface After Bracket Debonding | At completion of treatment, 10 minutes. | 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. |
| Time Required for Adhesive Remnant Cleanup | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants This is a single-arm study. Participants receive both treatments at the same time. All participants are counted as one group at baseline. | 45 |
| Total | 45 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| 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
| Characteristic | All Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 45 Participants |
| Age, Continuous | 19.7 years STANDARD_DEVIATION 9.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 45 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 45 participants |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 45 | 0 / 45 |
| other Total, other adverse events | 0 / 45 | 0 / 45 |
| serious Total, serious adverse events | 0 / 45 | 0 / 45 |
Outcome results
Primary
Amount of Adhesive Remaining on the Tooth Surface After Bracket Debonding
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| APC Flash-Free Adhesive Coated Appliance System | Amount of Adhesive Remaining on the Tooth Surface After Bracket Debonding | 2.53 score on a scale | Standard Deviation 0.36 |
| APC II Adhesive Coated Appliance System | Amount of Adhesive Remaining on the Tooth Surface After Bracket Debonding | 2.29 score on a scale | Standard Deviation 0.4 |
Primary
Bonding Time
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.
Time frame: At appliance placement, 30 minutes
Population: All participants who received the treatment are included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| APC Flash-Free Adhesive Coated Appliance System | Bonding Time | 42.5 seconds | Standard Deviation 5.9 |
| APC II Adhesive Coated Appliance System | Bonding Time | 67.7 seconds | Standard Deviation 5.9 |
Primary
Bond Survival
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.
Time frame: 1 year post treatment
Population: Of the 45 participants who completed treatment, 43 completed the follow-up period and are included in this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| APC Flash-Free Adhesive Coated Appliance System | Bond Survival | 8 failed bracket bonds |
| APC II Adhesive Coated Appliance System | Bond Survival | 2 failed bracket bonds |
Primary
Time Required for Adhesive Remnant Cleanup
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.
Time frame: At completion of treatment, 30 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| APC Flash-Free Adhesive Coated Appliance System | Time Required for Adhesive Remnant Cleanup | 167.3 seconds | Standard Deviation 63.5 |
| APC II Adhesive Coated Appliance System | Time Required for Adhesive Remnant Cleanup | 215.1 seconds | Standard Deviation 79.8 |