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| Name | Class |
|---|---|
| 3M | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| APC Flash-Free Adhesive Coated Appliance System | Experimental | APC Flash-Free Adhesive Coated Appliance System |
|
| APC II Adhesive Coated Appliance System | Active Comparator | APC II Adhesive Coated Appliance System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| APC Flash-Free Adhesive Coated Appliance System | Device | APC Flash-Free Adhesive Coated Appliance System |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At appliance placement, 30 minutes |
| 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. | 1 year post treatment |
| 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. | At completion of treatment, 10 minutes. |
| 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. | At completion of treatment, 30 minutes. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thorsten Gruenheid, DDS, PhD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30384932 | Derived | Grunheid T, Larson BE. Comparative assessment of bonding time and 1-year bracket survival using flash-free and conventional adhesives for orthodontic bracket bonding: A split-mouth randomized controlled clinical trial. Am J Orthod Dentofacial Orthop. 2018 Nov;154(5):621-628. doi: 10.1016/j.ajodo.2018.05.012. | |
| 30230375 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Enrollment |
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| APC Flash-Free Adhesive Coated Appliance |
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| APC II Adhesive Coated Appliance System |
| ||||||||||||||||||||||
| Follow-up |
|
All participants who received the treatment are included. The 4 participants who signed a consent, but did not begin treatment are excluded.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All participants who received the treatment are included in this analysis. | Posted | Mean | Standard Deviation | seconds | At appliance placement, 30 minutes |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | APC Flash-Free Adhesive Coated Appliance System | APC Flash-Free Adhesive Coated Appliance System APC Flash-Free Adhesive Coated Appliance System: APC Flash-Free Adhesive Coated Appliance System Only the 45 participants who received treatment are included in the adverse event reporting. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thorsten Gruenheid | University of Minnesota | 612-625-3903 | tgruenhe@umn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | May 14, 2013 | Nov 18, 2020 | ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 14, 2013 | Dec 18, 2020 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D008310 | Malocclusion |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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Split-mouth
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| APC II Adhesive Coated Appliance System | Device | APC II Adhesive Coated Appliance System |
|
| Grunheid T, Larson BE. A comparative assessment of bracket survival and adhesive removal time using flash-free or conventional adhesive for orthodontic bracket bonding: A split-mouth randomized controlled clinical trial. Angle Orthod. 2019 Mar;89(2):299-305. doi: 10.2319/030918-195.1. Epub 2018 Sep 19. |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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APC II Adhesive Coated Appliance System
APC II Adhesive Coated Appliance System: APC II Adhesive Coated Appliance System
|
|
| 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. | Of the 45 participants who completed treatment, 43 completed the follow-up period and are included in this analysis. | Posted | Number | failed bracket bonds | 1 year post treatment |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | At completion of treatment, 10 minutes. |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | seconds | At completion of treatment, 30 minutes. |
|
|
|
| 0 |
| 45 |
| 0 |
| 45 |
| 0 |
| 45 |
| EG001 | APC II Adhesive Coated Appliance System | APC II Adhesive Coated Appliance System APC II Adhesive Coated Appliance System: APC II Adhesive Coated Appliance System Only the 45 participants who received treatment are included in the adverse event reporting. | 0 | 45 | 0 | 45 | 0 | 45 |
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