EXD-959 Esthetic Ceramic Self-ligating Orthodontic Brackets and EXD-961 Related Instruments Trial: A Multicenter Case Series Study of the Performance o the EXD-959 Ceramic Bracket System in New and Intercept Orthodontic Patients
Sponsor study identifier
observational
78
1 country
5
Study Start
June 21, 2018
Actual (reported)Primary Completion
December 30, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The purpose of this study is to assess the performance of the EXD-959 self-ligating ceramic bracket system using EXD 961 instruments in the treatment of orthodontic malocclusion. The information gained in this study and other studies will be used to evaluate the clinical performance of the bracket system during orthodontic treatment and to substantiate marketing claims for the bracket system, open/close instrument and de-bonding instrument.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 21, 2018
Actual (reported)July 2, 2018
Actual (reported)July 31, 2018
Actual (reported)December 30, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
April 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Performance and functionality of the EXD-959 Bracket System and Related EXD-961 instruments in correcting dental malocclusions.
Validate that the EXD-959 Bracket System and Related EXD-961 instruments meet the user needs based on sponsor solicited feedback from dental professionals using, and patients wearing, these new orthodontic brackets.
The primary time-frame will be based on the Visit 4 data (12-16-wk post-baseline).
Orthodontists' ability to correct rotated teeth in dental patients as assessed using a questionnaire with a 7-point Likert scale
The primary time-frame will be based on the Visit 4 data (12-16-wk post-baseline).
Torque control assessed using a questionnaire with a 7-point Likert scale
The primary time-frame will be based on the Visit 4 data (12-16-wk post-baseline).
Study subjects' assessment of bracket comfort assessed using a a questionnaire with a 7-point Likert scale scale
The primary time-frame will be based on the Visit 4 data (12-16-wk post-baseline).
Bond strength; assessed using the percent of total brackets that unintentionally debond, as captured on a bond failure tracking form.
The primary time-frame will be based on the Visit 4 data (12-16-wk post-baseline).
Study subjects' assessment of bracket esthetics by using a questionnaire and a 7-point Likert scale.
The primary time-frame will be based on the Visit 4 data (12-16-wk post-baseline).
New patient subjects who are just initiating full orthodontic treatment will have their premolars, canines, and incisors bonded with the EXD-959 Bracket System, using the related EXD-961 instruments, according to the manufacturer's IFU. Their remaining teeth will be bonded with the brackets of the orthodontist's choice. Three of the 5 new patients recruited may be patients that the orthodontist will choose to initiate treatment with the EXD-959 study brackets being applied to the upper teeth only. Having this option will allow the investigators to recruit subjects with deeper over-bites where their standard of care would be to apply esthetic brackets on the upper teeth and metal brackets on the lower teeth.
This group will include a minimum of three, and up to 5 patients at each study site who have moved into rectangular wires; and in whom, the orthodontist- investigator believes they will be able to evaluate rotation corrections using the EXD-959 Bracket System. For example, rotation correction of the upper central incisor which will test the width of the bracket's holding points in situations that have wide teeth and greater inter-bracket distance.
This group will include a minimum of three, and up to 5 patients per study site who are estimated to be within 4 months of completing their orthodontic treatment; and in whom, the orthodontist-investigator believes they will be able to evaluate both torque control and debonding experiences using the EXD-959 Bracket System.
EXD-959 Ceramic Self-ligating Brackets are a new type of esthetic ceramic bracket developed by 3M™ Oral Care Solutions. The brackets have a sliding door and are composed of alumina (aluminum oxide) and small amounts of related oxide compounds (glass powder) to give them a clear appearance. A nickel-titanium wire serves as part of the door mechanism and is attached to the bracket using 3M ESPE™ Scotchbond™ Universal Adhesive. The brackets are classified as a Class II medical device. A FDA 510(k) submission of EXD-959 was submitted the first quarter of 2018.
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A total of 78 male and female subjects whose permanent teeth are erupted and who will be/are undergoing orthodontic treatment at the study offices that are participating in this trial.
McComb Orthodontics
Culver City, California, 90291, United States
Shults Orthodontics
Wellington, Florida, 33414, United States
Minnesota Orthodontics
Northfield, Minnesota, 55057, United States
Alvetro Orthodontics
Sidney, Ohio, 45635, United States
Simply Smiles
McKinney, Texas, 75050, United States
Patricia A Lenton, MA, CCRP
3M
78 participants (actual enrollment reported by the registry).
First Submitted
July 2, 2018
First Posted
July 31, 2018
Study Start
June 21, 2018
Actual (reported)Accelerated Invisalign Therapy in Conjunction With Acceledent Aura
Contact the study team to confirm eligibility.
Primary Completion
December 30, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
February 21, 2021
Record last verified: 2021-02
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Source: ClinicalTrials.gov.
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