Orthodontic Tooth MovementNCT05905224
Clinical Trial to Assess the Efficacy of Reducing the Aligners' Wear Protocol
A study testing Invisalign 7-day wear protocol and Invisalign 3-day wear protocol in people with Orthodontic Tooth Movement, run by University of Florida at 1 site in United States.
Trial summary
The hypothesis of this project is that replacing the current 7-day wear protocol with a 3-day wear protocol, while integrating less tooth movement per aligner (reduce the amount of activation per aligner) may produce more consistent and continues orthodontic forces, therefore, increase the predictability, accuracy and… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Tooth Movement
- What is being tested?
- Invisalign 7-day wear protocol and Invisalign 3-day wear protocol
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2023to 28 Feb 2026
- 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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Physically healthy with no relevant allergies or medical problems
- Male or female between the age of 18 and 30.
- Full permanent dentition except for the third molars
- Class I crowded dentition primarily for the lower anterior teeth (moderate crowding - 4-6 mm - according to Little's Irregularity Index)
- Good oral hygiene and absence of periodontal disease
- Malocclusion to be treated with Invisalign aligners (SmartTrack)
- Any ethnic group
Who cannot join
- Orthognathic surgical cases
- An extraction treatment plan
- Poor oral hygiene
- Patients with syndromes or craniofacial anomalies.
- The use of any other orthodontic appliance than clear aligners' (Invisalign)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Florida _ Department of Orthodontics
Gainesville, Florida, 32610-0444
About this study
Official title: A Randomized Clinical Trial to Assess the Efficacy of Reducing the Aligners' Wear Protocol on the Predictability of Orthodontic Tooth Movement
The hypothesis of this project is that replacing the current 7-day wear protocol with a 3-day wear protocol, while integrating less tooth movement per aligner (reduce the amount of activation per aligner) may produce more consistent and continues orthodontic forces, therefore, increase the predictability, accuracy and outcomes achieved for various types of tooth movements and enhance the rate of tooth movement with the Invisalign system
Read the detailed description
This randomized clinical trial aims to assess the effectiveness of increasing the frequency of change per aligner, within the standard of care, on the efficacy of achieving better treatment outcomes. We will study the influence of reducing the wear scheduled for Invisalign clear aligners, from 7-day change per aligner to 3-day change per aligner, on the predictability and accuracy of different orthodontic tooth movements by comparing the simulated predicted final outcomes to those achieved at the end of treatment between the two change protocols.
- Conditions
- Orthodontic Tooth Movement
- Being tested
- Invisalign 7-day wear protocol, Invisalign 3-day wear protocol
- Keywords
- clear aligners, wear protocol, 3-day wear, 7-day wear, rate and amount of tooth movement, accuracy, outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Invisalign 7-day wear protocolDevice
Clear Aligners' (Invisalign, Align technology, San Jose, Calif) 7-day wear protocol
Invisalign 3-day wear protocolDevice
Clear Aligners' (Invisalign, Align technology, San Jose, Calif) 3-day wear protocol
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Control) | Active comparator | Not described Receives: Device: Invisalign 7-day wear protocol |
| Group 2 (Experimental) | Experimental | Not described Receives: Device: Invisalign 3-day wear protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Deviation Between Predicted and Achieved Mandibular Incisor Tooth Movement-Linear Deviation Movements Achieved at the End of Treatment in Each of the Studied Groups (3-day Wear vs 7-day Wear).
Absolute linear deviation between predicted and achieved positions of the four mandibular incisors (teeth 31, 32, 41, and 42) after the initial aligner series, assessed by three-dimensional digital model superimposition in Geomagic Control X. For each tooth, mesiodistal (Δx), buccolingual (Δy), and occlusogingival (Δz) coordinate differences were combined into one Euclidean distance (mm): √(Δx² + Δy² + Δz²). Thus, the three directional differences were not separately averaged or summed. The four tooth-specific distances were averaged to obtain one value per participant. The median of participant-level values was reported for each treatment group. Lower values indicate greater accuracy of programmed tooth movement.
Measured: 14 months
Rate of Tooth Movement of the Mandibular Anterior Teeth Using DentalMonitoring® Detected by the Consecutive Scans Captured by the Scan Box (Dental Monitoring®) in the First 8 Weeks of Treatment
The rate of movement of the mandibular anterior teeth was assessed from consecutive intraoral scans captured by participants using the DentalMonitoring® ScanBox and smartphone application. Changes in tooth position between sequential scans were analyzed using the DentalMonitoring® platform. A higher value indicates a faster rate of tooth movement.
Time Frame: From initiation of aligner treatment through 2 months Unit of Measure: mm/week
Measured: 2 months
Absolute Deviation Between Predicted and Achieved Mandibular Incisor Linear Tooth Movement Between the Predicted Clinical Model and Actual Achieved Clinical Outcome
Predicted tooth positions from the final stage of the initial ClinCheck treatment plan were compared with achieved positions from intraoral scans after the initial aligner series. Mandibular incisors (31, 32, 41, and 42) were assessed using three-dimensional digital model superimposition in Geomagic Control X. For each tooth, mesiodistal (Δx), buccolingual (Δy), and occlusogingival (Δz) differences were combined into one Euclidean distance (mm): √(Δx² + Δy² + Δz²). The three directional differences were not separately averaged or summed. The four tooth-specific distances were averaged to obtain one value per participant. The median of participant-level values was reported for each treatment group. Lower values indicate greater agreement between predicted and achieved positions. A deviation ≥0.5 mm was considered clinically significant based on the American Board of Orthodontics threshold.
Measured: At completion of the initial aligner series, up to 14 months after aligner delivery
Secondary outcomes (4)
Duration of Treatment in Months Between Those Patients Who Changed Their Aligners Every 3 Days vs Those Who Changed Their Aligners Every 7 Days
the total time needed to complete the treatment and alignment of the lower anterior teeth was calculated and compared between the 2 groups in days
Measured: 14 months
Number of Additional Aligner Refinement Series Required to Complete Treatment
The total number of additional aligner refinement series prescribed after completion of the initial aligner series to achieve the planned treatment objectives. A refinement series was defined as an additional set of aligners prescribed to correct residual tooth-position discrepancies or incomplete planned tooth movements. Each refinement series was counted separately, including multiple series prescribed to the same participant. Results represent the total number of refinement series required in each treatment group.
Measured: 14 months
Final Occlusal Outcome Assessed Using the Weighted Peer Assessment Rating Index
The weighted Peer Assessment Rating (PAR) Index was used to evaluate malocclusion severity and final occlusal outcomes. The index assesses anterior alignment, buccal occlusion, overjet, overbite, and centerline discrepancies. Each component is scored and multiplied by its corresponding weighting factor, and the weighted component scores are summed to obtain the total weighted PAR score. Total scores range from 0 to 60, with 0 indicating no detectable deviation from ideal occlusion. Lower scores indicate better occlusal outcomes and less residual malocclusion, whereas higher scores indicate worse outcomes and greater malocclusion severity. The median total weighted PAR score and interquartile range at completion of orthodontic treatment were reported for each treatment group.
Measured: At completion of orthodontic treatment, up to 14 months
Total Number of Clinical Visits Required to Complete Treatment
Total number of scheduled clinical visits required for each participant from aligner delivery through completion of orthodontic treatment. Lower values indicate fewer clinical visits and reduced treatment burden.
Measured: From aligner delivery through treatment completion, up to 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start30 Oct 2023
- Primary completion30 Jan 2026
- Study completion28 Feb 2026
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 Orthodontic Tooth MovementStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah Abu Arqub, DDS, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05905224
- Sponsor's protocol ID
- IRB202300981
- Status last verified
- Mar 2025
- First submitted
- 4 May 2023
- Last updated
- 30 Oct 2026
- 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 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial to Assess the Efficacy of Reducing the Aligners' Wear Protocol on the Predictability of Orthodontic Tooth Movement
- ClinicalTrials.gov ID
- NCT05905224
- Acronym / sponsor ID
- IRB202300981
- Conditions
- Orthodontic Tooth Movement
- Keywords
- clear aligners, wear protocol, 3-day wear, 7-day wear, rate and amount of tooth movement, accuracy, outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 30 Oct 2023 (actual)
- Primary completion
- 30 Jan 2026 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 15 Jun 2023 (actual)
- Results
- Posted 30 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The hypothesis of this project is that replacing the current 7-day wear protocol with a 3-day wear protocol, while integrating less tooth movement per aligner (reduce the amount of activation per aligner) may produce more consistent and continues orthodontic forces, therefore, increase the predictability, accuracy and outcomes achieved for various types of tooth movements and enhance the rate of tooth movement with the Invisalign system
Detailed description
This randomized clinical trial aims to assess the effectiveness of increasing the frequency of change per aligner, within the standard of care, on the efficacy of achieving better treatment outcomes. We will study the influence of reducing the wear scheduled for Invisalign clear aligners, from 7-day change per aligner to 3-day change per aligner, on the predictability and accuracy of different orthodontic tooth movements by comparing the simulated predicted final outcomes to those achieved at the end of treatment between the two change protocols.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Control) | Active comparator | Device: Invisalign 7-day wear protocol |
| Group 2 (Experimental) | Experimental | Device: Invisalign 3-day wear protocol |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Physically healthy with no relevant allergies or medical problems
- Male or female between the age of 18 and 30.
- Full permanent dentition except for the third molars
- Class I crowded dentition primarily for the lower anterior teeth (moderate crowding - 4-6 mm - according to Little's Irregularity Index)
- Good oral hygiene and absence of periodontal disease
Key exclusion criteria (5 listed)
- Orthognathic surgical cases
- An extraction treatment plan
- Poor oral hygiene
- Patients with syndromes or craniofacial anomalies.
- The use of any other orthodontic appliance than clear aligners' (Invisalign)
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 |
|---|---|---|
| Invisalign 7-day wear protocolClear Aligners' (Invisalign, Align technology, San Jose, Calif) 7-day wear protocol | Device | Group 1 (Control) |
| Invisalign 3-day wear protocolClear Aligners' (Invisalign, Align technology, San Jose, Calif) 3-day wear protocol | Device | Group 2 (Experimental) |
Primary outcome
Deviation Between Predicted and Achieved Mandibular Incisor Tooth Movement-Linear Deviation Movements Achieved at the End of Treatment in Each of the Studied Groups (3-day Wear vs 7-day Wear).
Time frame: 14 months
Absolute linear deviation between predicted and achieved positions of the four mandibular incisors (teeth 31, 32, 41, and 42) after the initial aligner series, assessed by three-dimensional digital model superimposition in Geomagic Control X. For each tooth, mesiodistal (Δx), buccolingual (Δy), and occlusogingival (Δz) coordinate differences were combined into one Euclidean distance (mm): √(Δx² + Δy² + Δz²). Thus, the three directional differences were not separately averaged or summed. The four tooth-specific distances were averaged to obtain one value per participant. The median of participant-level values was reported for each treatment group. Lower values indicate greater accuracy of programmed tooth movement.
Rate of Tooth Movement of the Mandibular Anterior Teeth Using DentalMonitoring® Detected by the Consecutive Scans Captured by the Scan Box (Dental Monitoring®) in the First 8 Weeks of Treatment
Time frame: 2 months
The rate of movement of the mandibular anterior teeth was assessed from consecutive intraoral scans captured by participants using the DentalMonitoring® ScanBox and smartphone application. Changes in tooth position between sequential scans were analyzed using the DentalMonitoring® platform. A higher value indicates a faster rate of tooth movement. Time Frame: From initiation of aligner treatment through 2 months Unit of Measure: mm/week
Absolute Deviation Between Predicted and Achieved Mandibular Incisor Linear Tooth Movement Between the Predicted Clinical Model and Actual Achieved Clinical Outcome
Time frame: At completion of the initial aligner series, up to 14 months after aligner delivery
Predicted tooth positions from the final stage of the initial ClinCheck treatment plan were compared with achieved positions from intraoral scans after the initial aligner series. Mandibular incisors (31, 32, 41, and 42) were assessed using three-dimensional digital model superimposition in Geomagic Control X. For each tooth, mesiodistal (Δx), buccolingual (Δy), and occlusogingival (Δz) differences were combined into one Euclidean distance (mm): √(Δx² + Δy² + Δz²). The three directional differences were not separately averaged or summed. The four tooth-specific distances were averaged to obtain one value per participant. The median of participant-level values was reported for each treatment group. Lower values indicate greater agreement between predicted and achieved positions. A deviation ≥0.5 mm was considered clinically significant based on the American Board of Orthodontics threshold.
4 secondary outcomes
Duration of Treatment in Months Between Those Patients Who Changed Their Aligners Every 3 Days vs Those Who Changed Their Aligners Every 7 Days
Time frame: 14 months
Number of Additional Aligner Refinement Series Required to Complete Treatment
Time frame: 14 months
Final Occlusal Outcome Assessed Using the Weighted Peer Assessment Rating Index
Time frame: At completion of orthodontic treatment, up to 14 months
Total Number of Clinical Visits Required to Complete Treatment
Time frame: From aligner delivery through treatment completion, up to 14 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Sarah Abu Arqub, DDS principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Invisalign 7-day wear protocol and Invisalign 3-day wear protocol in people with Orthodontic Tooth Movement, run by University of Florida at 1 site 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 7 inclusion and 5 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: finished, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 30 Oct 2026). 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?
Deviation Between Predicted and Achieved Mandibular Incisor Tooth Movement-Linear Deviation Movements Achieved at the End of Treatment in Each of the Studied Groups (3-day Wear vs 7-day Wear). (time frame: 14 months). The study lists 3 primary outcomes in all. 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 30 Oct 2026.