EXD-959 Orthodontic Brackets and EXD-961 Related Instruments Trial

NCT03606551 | Unknown FDA Device

• 1 other identifier: EM-11-050006
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Malocclusion

Keywords

Self-ligating; Orthodontic; Esthetic

Outcome Measures

Primary Outcomes (1)

• 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).

Secondary Outcomes (7)

• 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).

Study Arms (3)

New Orthodontic Patients

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.

Device: EXD-959 Bracket System

Intercept Orthodontic Patients-Progress

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.

Device: EXD-959 Bracket System

Intercept Orthodontic Patients-Finishing

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.

Device: EXD-959 Bracket System

Interventions

EXD-959 Bracket System DEVICE

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.

Intercept Orthodontic Patients-Finishing; Intercept Orthodontic Patients-Progress; New Orthodontic Patients

Eligibility Criteria

• Age: 11 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Able to understand and willing to voluntarily sign the consent/assent form(s);
• Willing and able to return to the study facility for scheduled visits and recalls;
• Have permanent dentition including first molars, premolars, canines, and incisors erupted;
• Teeth have sound, non-carious buccal enamel, free from white-spot lesions; and,
• Have good oral hygiene as determined by the orthodontist/dental hygienist.
• For intercept patients only:
• Currently have brackets on their teeth; and,
• Have begun treatment with rectangular archwires; or, who are in their finishing stage of orthodontic treatment (i.e. they have 3 to 4 months of treatment remaining).

You may not qualify if:

• Currently participating in another clinical study.
• Difficulty being compliant with study visits, such as those planning or having extensive travel commitments or who lack transportation.
• Have mental, emotional, or developmental disabilities.
• Have a complex/surgical case.
• Have a deep overbite that would result in their maxillary incisor teeth occluding with the ceramic brackets on the mandibular teeth that cannot be avoided.
• Need essential dental care, i.e., for broken teeth, grossly carious or abscessed teeth.
• Have dental prostheses/implants that will interfere with projected teeth movement.
• Have known allergies to product ingredients (e.g. methacrylate resin materials, nickel, chromium).
• Have a medical or oral condition that, in the investigator's judgement, may compromise the subject's safety or interfere with the conduct and outcome of the study.

Sponsors & Collaborators

• 3M: lead

Study Sites (5)

McComb Orthodontics

Culver City, California, 90291, United States

Location

Shults Orthodontics

Wellington, Florida, 33414, United States

Location

Minnesota Orthodontics

Northfield, Minnesota, 55057, United States

Location

Alvetro Orthodontics

Sidney, Ohio, 45635, United States

Location

Simply Smiles

McKinney, Texas, 75050, United States

Location

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Patricia A Lenton, MA, CCRP

  3M

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2018
• First Posted: July 31, 2018
• Study Start: June 21, 2018
• Primary Completion: December 30, 2021
• Study Completion: April 30, 2022
• Last Updated: February 21, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)