Aligner Therapy, Orthodontic Aligner, Teeth Straightening
Conditions
Brief summary
The purpose of this research study is to see if Nighttime Aligners (worn 10-12 hours per day or night) are effective and safe for tooth movement and if so, how they compare with the standard Daytime aligners (worn 20-22 hours per day), in adults and children from 12 years of age and older. It will investigate the efficacy and performance of the treatments, as well as the safety of the investigational device and comparator. The main objectives are: * Comparison between the two groups concerning actual vs planned tooth movements (measured by changes in tooth position) * Comparison between the two groups concerning the incidence of device or dental related AEs. * Overall dentist and participant satisfaction with the treatment. Participants will: * Be given orthodontic aligner therapy with the Daytime (20-22h/day) or Nighttime (10-12h/day) Aligners (randomly assigned) * Attend approximately 5 study during approximately 8-10 months
Interventions
DEVICENighttime Aligners
Nighttime aligners worn 10-12 hours per day or night during 2-8 months
DEVICEDaytime Aligners
Daytime aligners worn 20-22 hours per day or night during 2-8 months
Sponsors
Dentsply Sirona Implants and Consumables
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject willing to participate in the clinical study and able to understand the content of the clinical study. 2. Subject must have permanent dentition (i.e. all second molars). 3. Subject must be 12 years of age or older. 4. Subject must be able to provide and sign consent for themselves, without requiring consent to be given by a legally authorized representative. Parental consent is also required for all participants who are not of the legal age to provide consent themselves (based on participant state of residence). 5. The subject requires correction of teeth without planned extrusive movements on either or both arches. 6. The subject has no greater than 5 mm of crowding and/or spacing (based on estimation by Investigator). 7. The subject does not require planned correction of molar tooth positions, posterior bite or molar classic relationship corrections. Subjects with Class II or Class III malocclusions requiring posterior bite / class correction are not eligible. 8. Subjects without prior orthodontic treatment within the past 18 months. 9. Subjects who are periodontally stable. 10. Subjects without a known history of plastic allergies. 11. Subjects who have not had or do not require tooth extractions in preparation for orthodontic treatment with aligners. 12. Subjects with a treatment plan that does not include the use of elastics.
Exclusion criteria
1. Unlikely to be able to comply with clinical study procedures according to Investigator's judgement. 2. Unable or unwilling to return for follow-up visits. 3. Previous enrolment in the present clinical study. 4. Involvement in the planning and conduct of the clinical study (applies to both Sponsor personnel and the clinical study site) 5. Participation in another clinical study that may interfere with the present clinical study. 6. Subjects who have active carries, where there is no plan to correct them prior to the start of aligner therapy. 7. Other dental or clinical pathologies, which in the judgment of the Investigator, deem the candidates inappropriate for participation in the study (e.g. clinically significant periodontal disease or gingivitis, interproximal decay, etc.). 8. The subject require interproximal reduction or attachments to obtain a corrected malocclusion. 9. In addition to the criteria listed above, this product is contraindicated for use in adult and adolescent subjects presenting with the following dental conditions: * Active periodontal disease * Severe open bite or severe overjet * Tooth malocclusion requiring surgical correction * Subject with mixed dentition * Subject with a skeletally narrow jaw * Dental prosthetics/implants or significant number of missing teeth 10. Known pregnancy, pregnancy tests will be performed as per local requirements.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peer Assessment Rating (PAR) Index | From day 0 (Treatment start) up to 8 months post treatment start (Final visit) | Comparison between actual vs planned tooth movements, compared between the investigational treatment and the control device |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject Satisfaction With the Treatment | At the final visit (2-8 months post day 0) | Overall subject satisfaction with the treatment assessed by a questionnaire using a rating scale from 1 to 10 (1 very satisfied - 10 very unsatisfied). |
| Dentist (Investigator) Satisfaction With the Treatment | At the final visit (2-8 months post day 0) | Overall dentist (investigator) satisfaction with the treatment assessed by a questionnaire using a rating scale from 1 to 10 (1 very satisfied - 10 very unsatisfied). |
| Subject Self-reported Pain/Discomfort | At each follow-up visit (Follow-up visits every 4-6 weeks post Day 0 during a 2-8 months period) and at the final visit (Day 0 + 2-8 months). | The subject self-reported values pertaining to pain/discomfort during treatment and comfort in wearing the aligners captured in a questionnaire with Visual Analogue Scale (VAS) with a Wong Baker face scale (score 0-10), where a higher score corresponds to a higher level of pain/discomfort. |
Countries
United States
Participant flow
Pre-assignment details
This study was terminated early. At time of study termination seven (7) subjects had been consented (started), out of which only one subject had been randomised and allocated a treatment arm (Treatment Start Visit). To report the six (6) subjects not yet assigned a treatment arm at time of early study termination, an additional Arm Treatment Not assigned was included.
Participants by arm
| Arm | Count |
|---|---|
| Aligners Either Nighttime Aligners worn 10-12 hours per day or night, or daytime aligners worn 20-22 hours day and night | 7 |
| Total | 7 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Early study termination | 1 | 0 | 6 |
Baseline characteristics
| Characteristic | Aligners | — |
|---|---|---|
| Age, Continuous | 32.4 Years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 5 Participants | — |
| Sex: Female, Male Male | 2 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 0 | 0 / 6 |
| other Total, other adverse events | 1 / 1 | 0 / 0 | 0 / 6 |
| serious Total, serious adverse events | 0 / 1 | 0 / 0 | 0 / 6 |
Outcome results
Primary
Peer Assessment Rating (PAR) Index
Comparison between actual vs planned tooth movements, compared between the investigational treatment and the control device
Time frame: From day 0 (Treatment start) up to 8 months post treatment start (Final visit)
Population: No subject conducted the final visit prior to early study termination. Consequently, no outcome data has been obtained in the study for this outcome and can thus not be presented.
Secondary
Dentist (Investigator) Satisfaction With the Treatment
Overall dentist (investigator) satisfaction with the treatment assessed by a questionnaire using a rating scale from 1 to 10 (1 very satisfied - 10 very unsatisfied).
Time frame: At the final visit (2-8 months post day 0)
Population: No subject conducted the final visit prior to early study termination. Consequently, no outcome data has been obtained in the study for this outcome and can thus not be presented.
Secondary
Subject Satisfaction With the Treatment
Overall subject satisfaction with the treatment assessed by a questionnaire using a rating scale from 1 to 10 (1 very satisfied - 10 very unsatisfied).
Time frame: At the final visit (2-8 months post day 0)
Population: No subject conducted the final visit prior to early study termination. Consequently, no outcome data has been obtained in the study for this outcome and can thus not be presented.
Secondary
Subject Self-reported Pain/Discomfort
The subject self-reported values pertaining to pain/discomfort during treatment and comfort in wearing the aligners captured in a questionnaire with Visual Analogue Scale (VAS) with a Wong Baker face scale (score 0-10), where a higher score corresponds to a higher level of pain/discomfort.
Time frame: At each follow-up visit (Follow-up visits every 4-6 weeks post Day 0 during a 2-8 months period) and at the final visit (Day 0 + 2-8 months).
Population: All subjects allocated a treatment arm (one subject in total).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Nighttime Aligners | Subject Self-reported Pain/Discomfort | Visit 1. Between this visit and the previous visit, how comfortable are the aligners to wear | 9 score on a scale |
| Nighttime Aligners | Subject Self-reported Pain/Discomfort | Visit 2. Between this visit and the previous visit, how comfortable are the aligners to wear | 9 score on a scale |
| Nighttime Aligners | Subject Self-reported Pain/Discomfort | Visit 3. Between this visit and the previous visit, how comfortable are the aligners to wear | 0 score on a scale |
| Nighttime Aligners | Subject Self-reported Pain/Discomfort | Visit 1. Pain associated with new tooth movement between this visit and the previous visit | 0 score on a scale |
| Nighttime Aligners | Subject Self-reported Pain/Discomfort | Visit 2. Pain associated with new tooth movement between this visit and the previous visit | 0 score on a scale |
| Nighttime Aligners | Subject Self-reported Pain/Discomfort | Visit 3. Pain associated with new tooth movement between this visit and the previous visit | 0 score on a scale |