Clinical Performance of a New Esthetic, Self-ligating Orthodontic Bracket

• Sponsor: University of Minnesota (Other)
• Overall Status: Completed
• CT.gov ID: NCT02959671
• Collaborator: 3M Oral Care (Other)
• Enrollment: 34
• Location: 1
• Arm: 1
• Duration (Months): 36
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

A cohort of 15 patients starting orthodontic treatment with fixed appliances will receive EXD-952 Ceramic Self-ligating brackets on all mandibular incisors and a different type of brackets on the remaining mandibular teeth. Tooth movement will be initiated using 0.014" or 0.016" Nickel-Titanium archwires.

A second cohort of 15 patients will receive EXD-952 Ceramic Self-ligating bracket on all mandibular incisors in a later phase of their ongoing orthodontic treatment. The mandibular incisor brackets will be removed and EXD-952 Ceramic Self-ligating brackets placed instead. Other mandibular brackets will remain in place. Tooth movement will be performed using 0.019x0.025" Stainless Steel archwires.

In both cohorts bracket door stability, the ability of the door to hold the archwire in the bracket slot, the bracket's ability to rotate teeth, clinicians' satisfaction with the bracket, and patient comfort in comparison with other brackets will be assessed.

The evaluation for each patient will last for at least until one archwire change (cohort 1) or one appointment interval (6-8 weeks, cohort 2).

After the evaluation period, EXD-952 Ceramic Self-ligating brackets will remain in place until the orthodontic treatment is completed.

Condition or Disease	Intervention/Treatment	Phase
Malocclusion	Device: Lower Anterior EXD-952 Self-ligating Brackets	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 34 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clinical Performance of a New Esthetic, Self-ligating Orthodontic Bracket
• Study Start Date: Jan 1, 2017
• Actual Primary Completion Date: Jan 1, 2020
• Actual Study Completion Date: Jan 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lower Anterior EXD-952 Self-ligating Brackets	Device: Lower Anterior EXD-952 Self-ligating Brackets; Placement of EXD-952 Self-ligating Brackets on mandibular incisors

Outcome Measures

Primary Outcome Measures

1. Bracket Door Stability [baseline]

   The stability of the bracket door is assessed at the time of bracket placement. Each bracket has 4 doors. Outcome is reported as the percent of bracket doors across all participants that break at bracket placement. Number of total broken bracket doors/number of total bracket doors across all participants * 100. Unit of measure is "percentage of bracket doors."

2. Ability of Door to Successfully Hold the Archwire in the Bracket Slot [baseline]

   The ability of door to hold the archwire in the bracket slot is assessed at the time of bracket placement. If the door is unable to hold the archwire, then spontaneous door opening occurs. Each bracket has 4 doors. Outcome is reported as the percent of bracket doors that successfully held the archwire within the bracket slot at bracket placement. Number of successful bracket doors/number of total bracket doors across all participants * 100. Unit of measure is "percentage of bracket doors."

3. Bracket's Ability to Rotate Teeth [6-8 weeks]

   The bracket's ability to rotate teeth will be assessed after the first archwire change (expected 6-8 weeks after initial bonding). Clinician will rate rotational correction as adequate or not adequate. Outcome is reported as the percent of participants for whom the clinician rated rotational correction as adequate.

4. Clinicians' Satisfaction With the Bracket [6-8 weeks]

   The clinician's satisfaction with the bracket will be assessed after the first archwire change (expected 6-8 weeks after initial bonding). Clinician will rate their satisfaction on a 5-point Likert scale (Very unsatisfied, somewhat unsatisfied, neutral, somewhat satisfied, very satisfied). A rating of 4 (somewhat satisfied) or 5 (very satisfied) is considered successful. Outcome is reported as the percent of participants for whom the clinician rated bracket satisfaction as somewhat satisfied or very satisfied.

5. Patient Comfort in Comparison With Other Brackets (Questionnaire) [6-8 weeks]

   The patient's comfort in comparison with other brackets will be assessed after the first archwire change (expected 6-8 weeks after initial bonding). Patients will rate their satisfaction on a 5-point Likert scale (Very unsatisfied, somewhat unsatisfied, neutral, somewhat satisfied, very satisfied). A rating of 4 (somewhat satisfied) or 5 (very satisfied) is considered successful. Outcome is reported as the percent of participants who rated their comfort in comparison with other brackets as somewhat satisfied or very satisfied.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 10 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Permanent mandibular dentition including incisors, canines, premolars, and first molars (includes subjects treated with the extraction of premolars)

• Mandibular incisors with sound, non-carious buccal enamel and no pretreatment with chemical agents such as hydrogen peroxide

Exclusion Criteria:

• Mental/emotional/developmental disability

• Inability to give informed consent

• 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 mandibular incisors

• Deep bite

• Known allergies to any study materials

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Minnesota	Minneapolis	Minnesota	United States	55455

Sponsors and Collaborators

• University of Minnesota
• 3M Oral Care

Investigators

None specified.

Study Documents (Full-Text)

• Informed Consent Form - Dec 20, 2016
• Study Protocol and Statistical Analysis Plan - Nov 3, 2016

More Information

Publications

None provided.

• Responsible Party: University of Minnesota
• ClinicalTrials.gov Identifier: NCT02959671
• Other Study ID Numbers: 1611M00321
• First Posted: Nov 9, 2016
• Last Update Posted: Jan 14, 2021
• Last Verified: Dec 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Malocclusion

Study Results

Participant Flow

Arm/Group Title	Lower Anterior EXD-952 Self-ligating Brackets
Arm/Group Description	Lower Anterior EXD-952 Self-ligating Brackets: Placement of EXD-952 Self-ligating Brackets on mandibular incisors
Period Title: Overall Study
STARTED	34
COMPLETED	29
NOT COMPLETED	5

Baseline Characteristics

Arm/Group Title	Lower Anterior EXD-952 Self-ligating Brackets
Arm/Group Description	Lower Anterior EXD-952 Self-ligating Brackets: Placement of EXD-952 Self-ligating Brackets on mandibular incisors
Overall Participants	31
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	22.8 (12.2)
Sex: Female, Male (Count of Participants)
Female	20 64.5%
Male	11 35.5%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	0 0%
More than one race	0 0%
Unknown or Not Reported	31 100%
Region of Enrollment (participants) [Number]
United States	31 100%

Outcome Measures

1. Primary Outcome

Title	Bracket Door Stability
Description	The stability of the bracket door is assessed at the time of bracket placement. Each bracket has 4 doors. Outcome is reported as the percent of bracket doors across all participants that break at bracket placement. Number of total broken bracket doors/number of total bracket doors across all participants * 100. Unit of measure is "percentage of bracket doors."
Time Frame	baseline

Outcome Measure Data

Analysis Population Description

All participants who participated in data collection for this measure are included.

Arm/Group Title	Lower Anterior EXD-952 Self-ligating Brackets
Arm/Group Description	Lower Anterior EXD-952 Self-ligating Brackets: Placement of EXD-952 Self-ligating Brackets on mandibular incisors
Measure Participants	31
Number [percentage of bracket doors]	0.8

2. Primary Outcome

Title	Ability of Door to Successfully Hold the Archwire in the Bracket Slot
Description	The ability of door to hold the archwire in the bracket slot is assessed at the time of bracket placement. If the door is unable to hold the archwire, then spontaneous door opening occurs. Each bracket has 4 doors. Outcome is reported as the percent of bracket doors that successfully held the archwire within the bracket slot at bracket placement. Number of successful bracket doors/number of total bracket doors across all participants * 100. Unit of measure is "percentage of bracket doors."
Time Frame	baseline

Outcome Measure Data

Analysis Population Description

All participants who participated in data collection for this measure are included.

Arm/Group Title	Lower Anterior EXD-952 Self-ligating Brackets
Arm/Group Description	Lower Anterior EXD-952 Self-ligating Brackets: Placement of EXD-952 Self-ligating Brackets on mandibular incisors
Measure Participants	31
Number [percentage of bracket doors]	96

3. Primary Outcome

Title	Bracket's Ability to Rotate Teeth
Description	The bracket's ability to rotate teeth will be assessed after the first archwire change (expected 6-8 weeks after initial bonding). Clinician will rate rotational correction as adequate or not adequate. Outcome is reported as the percent of participants for whom the clinician rated rotational correction as adequate.
Time Frame	6-8 weeks

Outcome Measure Data

Analysis Population Description

All participants who participated in data collection for this measure are included.

Arm/Group Title	Lower Anterior EXD-952 Self-ligating Brackets
Arm/Group Description	Lower Anterior EXD-952 Self-ligating Brackets: Placement of EXD-952 Self-ligating Brackets on mandibular incisors
Measure Participants	31
Number [percent of participants]	62.5 201.6%

4. Primary Outcome

Title	Clinicians' Satisfaction With the Bracket
Description	The clinician's satisfaction with the bracket will be assessed after the first archwire change (expected 6-8 weeks after initial bonding). Clinician will rate their satisfaction on a 5-point Likert scale (Very unsatisfied, somewhat unsatisfied, neutral, somewhat satisfied, very satisfied). A rating of 4 (somewhat satisfied) or 5 (very satisfied) is considered successful. Outcome is reported as the percent of participants for whom the clinician rated bracket satisfaction as somewhat satisfied or very satisfied.
Time Frame	6-8 weeks

Outcome Measure Data

Analysis Population Description

All participants who participated in data collection for this measure are included.

Arm/Group Title	Lower Anterior EXD-952 Self-ligating Brackets
Arm/Group Description	Lower Anterior EXD-952 Self-ligating Brackets: Placement of EXD-952 Self-ligating Brackets on mandibular incisors
Measure Participants	31
Number [percent of participants]	70 225.8%

5. Primary Outcome

Title	Patient Comfort in Comparison With Other Brackets (Questionnaire)
Description	The patient's comfort in comparison with other brackets will be assessed after the first archwire change (expected 6-8 weeks after initial bonding). Patients will rate their satisfaction on a 5-point Likert scale (Very unsatisfied, somewhat unsatisfied, neutral, somewhat satisfied, very satisfied). A rating of 4 (somewhat satisfied) or 5 (very satisfied) is considered successful. Outcome is reported as the percent of participants who rated their comfort in comparison with other brackets as somewhat satisfied or very satisfied.
Time Frame	6-8 weeks

Outcome Measure Data

Analysis Population Description

All participants who participated in data collection for this measure are included.

Arm/Group Title	Lower Anterior EXD-952 Self-ligating Brackets
Arm/Group Description	Lower Anterior EXD-952 Self-ligating Brackets: Placement of EXD-952 Self-ligating Brackets on mandibular incisors
Measure Participants	31
Number [percent of participants]	84 271%

Adverse Events

Time Frame	at least 6 weeks
Arm/Group Title	Lower Anterior EXD-952 Self-ligating Brackets
Arm/Group Description	Adverse event data was collected from 31 patients out of the 34 who signed the consent. Three participants signed the consent, but did not participate in data collection. They are excluded from data analysis.
All Cause Mortality
	Lower Anterior EXD-952 Self-ligating Brackets
	Affected / at Risk (%)	# Events
Total	0/31 (0%)
Serious Adverse Events
	Lower Anterior EXD-952 Self-ligating Brackets
	Affected / at Risk (%)	# Events
Total	0/31 (0%)
Other (Not Including Serious) Adverse Events
	Lower Anterior EXD-952 Self-ligating Brackets
	Affected / at Risk (%)	# Events
Total	2/31 (6.5%)
Product Issues
Enamel Wear of the Maxillary Incisors	2/31 (6.5%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE 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.