Teeth StraighteningNCT06539676
A Study to Compare Nighttime Aligners to Daytime Aligners
A study testing Nighttime Aligners and Daytime Aligners in people with Teeth Straightening and Aligner Therapy, run by Dentsply Sirona Implants and Consumables at 12 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Teeth Straightening, Aligner Therapy, Orthodontic Aligner
- What is being tested?
- Nighttime Aligners and Daytime Aligners
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 12 sitesUnited States
- Study dates
- 4 Sep 2024to 17 Jan 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subject willing to participate in the clinical study and able to understand the content of the clinical study.
- Subject must have permanent dentition (i.e. all second molars).
- Subject must be 12 years of age or older.
- 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).
- The subject requires correction of teeth without planned extrusive movements on either or both arches.
- The subject has no greater than 5 mm of crowding and/or spacing (based on estimation by Investigator).
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- 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.
- Subjects without prior orthodontic treatment within the past 18 months.
- Subjects who are periodontally stable.
- Subjects without a known history of plastic allergies.
- Subjects who have not had or do not require tooth extractions in preparation for orthodontic treatment with aligners.
- Subjects with a treatment plan that does not include the use of elastics.
Who cannot join
- Unlikely to be able to comply with clinical study procedures according to Investigator's judgement.
- Unable or unwilling to return for follow-up visits.
- Previous enrolment in the present clinical study.
- Involvement in the planning and conduct of the clinical study (applies to both Sponsor personnel and the clinical study site)
- Participation in another clinical study that may interfere with the present clinical study.
- Subjects who have active carries, where there is no plan to correct them prior to the start of aligner therapy.
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- 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.).
- The subject require interproximal reduction or attachments to obtain a corrected malocclusion.
- 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
- Known pregnancy, pregnancy tests will be performed as per local requirements.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Brush365
Frisco, Texas, 75035
Gustafson Dental
Humble, Texas, 77396
SKM Dentistry d/b/a brush365 Dental
Hurst, Texas, 76003
R. Lobato & Associates
Las Vegas, Nevada, 89117
3D Dental
Miami Beach, Florida, 33140
Gregson Family Dentistry
Milwaukee, Wisconsin, 17655
Huerta Dentistry
New York, New York, 10001
Aesthetic Dental
North Bergen, New Jersey, 07047
Cedars Family Dental
Plainville, Massachusetts, 02762
Northwest Dental Medicine
Puyallup, Washington, 98372
Fulbright Dental
Redondo Beach, California, 90277
Elite Dental of Towson
Towson, Maryland, 21204
About this study
Official title: A Prospective, Two-armed, Multicenter Clinical Study to Evaluate Efficacy, Performance, and Safety of Nighttime Aligners (Worn 10-12 Hours Day or Night) Compared to Daytime Aligners (Worn 20-22 Hours Day/Night)
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.
Read more
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
- Conditions
- Teeth Straightening, Aligner Therapy, Orthodontic Aligner
- Being tested
- Nighttime Aligners, Daytime Aligners
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nighttime AlignersDevice
Nighttime aligners worn 10-12 hours per day or night during 2-8 months
Daytime AlignersDevice
Daytime aligners worn 20-22 hours per day or night during 2-8 months
| Study group | Role | What they receive |
|---|---|---|
| Nighttime Aligners | Experimental | Nighttime Aligners worn 10-12 hours per day or night Receives: Device: Nighttime Aligners |
| Daytime Aligners | Active comparator | Daytime aligners worn 20-22 hours day and night Receives: Device: Daytime Aligners |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peer Assessment Rating (PAR) Index
Comparison between actual vs planned tooth movements, compared between the investigational treatment and the control device
Measured: From day 0 (Treatment start) up to 8 months post treatment start (Final visit)
Secondary outcomes (3)
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).
Measured: At the final visit (2-8 months post day 0)
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).
Measured: At the final visit (2-8 months post day 0)
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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start4 Sep 2024
- Primary completion17 Jan 2025
- Study completion17 Jan 2025
Why it stopped: Sponsor's decision to terminate study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Teeth StraighteningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dentsply Sirona Implants and Consumables
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jay Khorsandi, Dr, Study director, BYTE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06539676
- Sponsor's protocol ID
- C-OR-24-017
- Status last verified
- Jun 2025
- First submitted
- 28 Jun 2024
- Last updated
- 16 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Two-armed, Multicenter Clinical Study to Evaluate Efficacy, Performance, and Safety of Nighttime Aligners (Worn 10-12 Hours Day or Night) Compared to Daytime Aligners (Worn 20-22 Hours Day/Night)
- ClinicalTrials.gov ID
- NCT06539676
- Acronym / sponsor ID
- C-OR-24-017
- Conditions
- Teeth Straightening, Aligner Therapy, Orthodontic Aligner
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor's decision to terminate study.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Dentsply Sirona Implants and ConsumablesIndustry (pharma, biotech, devices)
- Study start
- 4 Sep 2024 (actual)
- Primary completion
- 17 Jan 2025 (actual)
- Study completion
- 17 Jan 2025 (actual)
- First posted
- 6 Aug 2024 (actual)
- Results
- Posted 16 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nighttime Aligners | Experimental | Device: Nighttime AlignersNighttime Aligners worn 10-12 hours per day or night |
| Daytime Aligners | Active comparator | Device: Daytime AlignersDaytime aligners worn 20-22 hours day and night |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Subject willing to participate in the clinical study and able to understand the content of the clinical study.
- Subject must have permanent dentition (i.e. all second molars).
- Subject must be 12 years of age or older.
- 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).
- The subject requires correction of teeth without planned extrusive movements on either or both arches.
Key exclusion criteria (16 listed)
- Unlikely to be able to comply with clinical study procedures according to Investigator's judgement.
- Unable or unwilling to return for follow-up visits.
- Previous enrolment in the present clinical study.
- Involvement in the planning and conduct of the clinical study (applies to both Sponsor personnel and the clinical study site)
- Participation in another clinical study that may interfere with the present clinical study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nighttime AlignersNighttime aligners worn 10-12 hours per day or night during 2-8 months | Device | Nighttime Aligners |
| Daytime AlignersDaytime aligners worn 20-22 hours per day or night during 2-8 months | Device | Daytime Aligners |
Primary outcome
Peer Assessment Rating (PAR) Index
Time frame: 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
3 secondary outcomes
Subject Satisfaction With the Treatment
Time frame: At the final visit (2-8 months post day 0)
Dentist (Investigator) Satisfaction With the Treatment
Time frame: At the final visit (2-8 months post day 0)
Subject Self-reported 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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jay Khorsandi, Dr study director
BYTE
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nighttime Aligners and Daytime Aligners in people with Teeth Straightening and Aligner Therapy, run by Dentsply Sirona Implants and Consumables at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peer Assessment Rating (PAR) Index (time frame: From day 0 (Treatment start) up to 8 months post treatment start (Final visit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2025; AzTrials last refreshed its copy on 30 Oct 2026.