Trial Outcomes & Findings for Clinical Performance of a New Esthetic, Self-ligating Orthodontic Bracket (NCT NCT02959671)

NCT ID: NCT02959671

Last Updated: 2021-01-14

Results Overview

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."

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 34 participants
• Primary outcome timeframe: baseline
• Results posted on: 2021-01-14

Participant Flow

Participant milestones

Measure	Lower Anterior EXD-952 Self-ligating Brackets Lower Anterior EXD-952 Self-ligating Brackets: Placement of EXD-952 Self-ligating Brackets on mandibular incisors
Overall Study STARTED	34
Overall Study COMPLETED	29
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Measure	Lower Anterior EXD-952 Self-ligating Brackets Lower Anterior EXD-952 Self-ligating Brackets: Placement of EXD-952 Self-ligating Brackets on mandibular incisors
Overall Study Adverse Event	2
Overall Study Participants signed a consent; however enrollment was complete before they started study activity.	3

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Lower Anterior EXD-952 Self-ligating Brackets n=31 Participants Lower Anterior EXD-952 Self-ligating Brackets: Placement of EXD-952 Self-ligating Brackets on mandibular incisors
Age, Continuous	22.8 years STANDARD_DEVIATION 12.2 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	11 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	31 Participants n=5 Participants
Region of Enrollment United States	31 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline

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

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."

Outcome measures

Measure	Lower Anterior EXD-952 Self-ligating Brackets n=31 Participants Lower Anterior EXD-952 Self-ligating Brackets: Placement of EXD-952 Self-ligating Brackets on mandibular incisors
Bracket Door Stability	0.8 percentage of bracket doors

PRIMARY outcome

Timeframe: baseline

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

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."

Outcome measures

Measure	Lower Anterior EXD-952 Self-ligating Brackets n=31 Participants Lower Anterior EXD-952 Self-ligating Brackets: Placement of EXD-952 Self-ligating Brackets on mandibular incisors
Ability of Door to Successfully Hold the Archwire in the Bracket Slot	96 percentage of bracket doors

PRIMARY outcome

Timeframe: 6-8 weeks

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

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.

Outcome measures

Measure	Lower Anterior EXD-952 Self-ligating Brackets n=31 Participants Lower Anterior EXD-952 Self-ligating Brackets: Placement of EXD-952 Self-ligating Brackets on mandibular incisors
Bracket's Ability to Rotate Teeth	62.5 percent of participants

PRIMARY outcome

Timeframe: 6-8 weeks

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

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.

Outcome measures

Measure	Lower Anterior EXD-952 Self-ligating Brackets n=31 Participants Lower Anterior EXD-952 Self-ligating Brackets: Placement of EXD-952 Self-ligating Brackets on mandibular incisors
Clinicians' Satisfaction With the Bracket	70 percent of participants

PRIMARY outcome

Timeframe: 6-8 weeks

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

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.

Outcome measures

Measure	Lower Anterior EXD-952 Self-ligating Brackets n=31 Participants Lower Anterior EXD-952 Self-ligating Brackets: Placement of EXD-952 Self-ligating Brackets on mandibular incisors
Patient Comfort in Comparison With Other Brackets (Questionnaire)	84 percent of participants

Adverse Events

Lower Anterior EXD-952 Self-ligating Brackets

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Lower Anterior EXD-952 Self-ligating Brackets n=31 participants at risk 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.
Product Issues Enamel Wear of the Maxillary Incisors	6.5% 2/31 • Number of events 2 • at least 6 weeks

Additional Information

Thorsten Gruenheid, DDS, PhD

University of Minnesota

Phone: 612-625-3903

Email: tgruenhe@umn.edu

Results disclosure agreements

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