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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02959671

Enrollment

Registered

2016-11-09

Start date

2017-01-31

Completion date

2020-01-31

Last updated

2021-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malocclusion

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.

Interventions

DEVICELower Anterior EXD-952 Self-ligating Brackets

Placement of EXD-952 Self-ligating Brackets on mandibular incisors

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

10 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.
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.
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.
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.
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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Lower Anterior EXD-952 Self-ligating Brackets Lower Anterior EXD-952 Self-ligating Brackets: Placement of EXD-952 Self-ligating Brackets on mandibular incisors	31
Total	31

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Adverse Event	2
Overall Study	Participants signed a consent; however enrollment was complete before they started study activity.	3

Baseline characteristics

Characteristic	Lower Anterior EXD-952 Self-ligating Brackets
Age, Continuous	22.8 years STANDARD_DEVIATION 12.2
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	31 Participants
Race (NIH/OMB) White	0 Participants
Region of Enrollment United States	31 participants
Sex: Female, Male Female	20 Participants
Sex: Female, Male Male	11 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 31
other Total, other adverse events	2 / 31
serious Total, serious adverse events	0 / 31

Outcome results

Primary

Ability of Door to Successfully Hold the Archwire in the Bracket Slot

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