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

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

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.

This prospective case-series study will evaluate the performance of the EXD-959 ceramic bracket system at baseline (BL), 4, and 6 months post-baseline, and at the time that each subject has their study brackets debonded (approx. 4 to 24 months). Bond failures and adverse events will be tracked throughout the entire study. A total of 78 study subjects will be enrolled in this study (30 new and 48 intercept cases). The patients will be recruited from a total of 6 participating study sites.

Self-Ligating (SL) Practitioners: The sponsor will recruit 4 orthodontist-investigators who have experience using and currently use self-ligating style orthodontic brackets.

Ligating (L) Practitioners: The sponsor will recruit 2 orthodontist-investigators who do NOT currently use self-ligating style orthodontic brackets in their practices. These will be practitioners who currently use brackets that require that either metal or elastomeric ties are used to secure the archwire into the bracket-slots.

Five new and 8 intercept subjects, who meet the inclusion/exclusion criteria and consent/assent to participate, will be enrolled at each study site (n = 13 per site).

• New patient subjects who are just initiating full orthodontic treatment will have their premolars, canines, and incisors bonded with the EXD-959 brackets, 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.

• Intercept patient subjects: Eight subjects will be recruited from patients who are currently undergoing orthodontic treatment. Their existing treatment will be intercepted. They will have the brackets currently on their upper and lower premolars, canines, and incisors debonded and replaced with the EXD-959 study brackets, preferably using the related EXD-961 instruments, according the manufacturer's IFU. Three of 8 new intercept patients recruited may have treatment initiated on upper teeth only.

• In order to evaluate rotation correction, torque control, bracket and bracket- door durability, and debonding experiences two types of intercept patients will be targeted:

  • Intercept - progress: this group will include a minimum of three 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. 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.
  • Intercept-finishing: this group will include a minimum of three 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.

As long as they recruit a minimum of 3 subjects in each intercept category, each orthodontist-investigator can then determine the total number of subjects recruited in each of the progress- and finishing-intercept groups in order to reach a total of 8 subjects. For example, at one site they might recruit 3 progress and 5 finishing subjects, while another site might recruit 4 progress and 4 finishing subjects.

In both SL and L practitioners the EXD-959 bracket system will be used in conjunction with the archwires prescribed by the treating orthodontists according to their respective treatment philosophies.

The study patients, treating orthodontists, and orthodontic staff who interact with the study subjects, the EXD brackets, and the EXD instruments will provide feedback related to specific attributes of the product at defined time-points, using the study documents provided by the study sponsor.

Inclusion Criteria:

1. Able to understand and willing to voluntarily sign the consent/assent form(s);

2. Willing and able to return to the study facility for scheduled visits and recalls;

3. Have permanent dentition including first molars, premolars, canines, and incisors erupted;

4. Teeth have sound, non-carious buccal enamel, free from white-spot lesions; and,

5. Have good oral hygiene as determined by the orthodontist/dental hygienist.

   For intercept patients only:

6. Currently have brackets on their teeth; and,

7. 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).

Exclusion Criteria:

1. Currently participating in another clinical study.
2. Difficulty being compliant with study visits, such as those planning or having extensive travel commitments or who lack transportation.
3. Have mental, emotional, or developmental disabilities.
4. Have a complex/surgical case.
5. 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.
6. Need essential dental care, i.e., for broken teeth, grossly carious or abscessed teeth.
7. Have dental prostheses/implants that will interfere with projected teeth movement.
8. Have known allergies to product ingredients (e.g. methacrylate resin materials, nickel, chromium).
9. 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.