MalocclusionNCT06882395
Impact of Aligner Replacement Protocols on Predictability of Planned Dental Movements: Evaluation of Double Aligner
A study testing Group 1: FLX aligners for 10 days, Group 3: FLX aligners for 7 days, followed by new FLX aligners for 3 days. and Group 2: FLX aligners worn for 7 days, followed by FLX35 aligners for 3 days. in people with Malocclusion and Clear Aligner Appliance, run by Neodent at 1 site in Brazil.
Trial summary
The study will evaluate the impact of replacing aligners after 7 days with new aligners made of different materials on the predictability of planned dental movements. Three groups of participants will follow different aligner protocols, and the planned movements will be compared with the achieved ones. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Malocclusion, Clear Aligner Appliance, Orthodontics
- What is being tested?
- Group 1: FLX aligners for 10 days, Group 3: FLX aligners for 7 days, followed by new FLX aligners for 3 days. and Group 2: FLX aligners worn for 7 days, followed by FLX35 aligners for 3 days.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteBrazil
- Study dates
- 6 Nov 2024to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older, with full permanent dentition.
- Interested in orthodontic treatment with aligners.
- Planned movements include extrusion, intrusion, rotation, tipping, or mesiodistal translation.
- Signed informed consent.
Who cannot join
- Contraindications to aligner use, including allergies to polyurethane or PETG.
- Poor oral hygiene or active periodontal disease.
- Malocclusions involving multiple missing teeth or short clinical crowns.
Trial locations and contacts
1 site in 1 country.
About this study
The study will evaluate the impact of replacing aligners after 7 days with new aligners made of different materials on the predictability of planned dental movements. Three groups of participants will follow different aligner protocols, and the planned movements will be compared with the achieved ones. The study aims to provide relevant data for clinical practices with orthodontic aligners and assess participants' satisfaction with the treatment.
Read the detailed description
This prospective clinical trial aims to determine whether replacing an aligner after 7 days with a new aligner of a different material affects the predictability of planned dental movements. A total of 114 adult patients undergoing orthodontic treatment with aligners-requiring bilateral tooth movements (extrusion, intrusion, rotation, tipping, or mesiodistal translation)-will be recruited and randomized into three groups with distinct aligner exchange protocols.
Group 1: 10 days of exclusive FLX aligner use. Group 2: 7 days of FLX aligner use followed by 3 days of FLX35 use. Group 3: 7 days of FLX aligner use followed by 3 days of a new FLX aligner. Within each group, patients will be further categorized into subgroups based on horizontal, vertical, and rotational movements. Digital study models, radiographs, and standardized clinical photographs will be used to compare planned versus achieved tooth movements. The primary outcome is the predictability of movement, defined as the difference and percentage of planned versus actual movement. Secondary outcomes include participant satisfaction measured via the OHIP-14 questionnaire. Data will be analyzed using descriptive statistics and paired tests appropriate for the split-mouth design. The study is conducted in accordance with the Declaration of Helsinki, and all treatment costs will be covered by the sponsor, NeoDent (JJGC Industria e Comercio de Materiais Dentarios S.A.).
- Conditions
- Malocclusion, Clear Aligner Appliance, Orthodontics, Tooth Movement
- Being tested
- Group 1: FLX aligners for 10 days, Group 3: FLX aligners for 7 days, followed by new FLX aligners for 3 days., Group 2: FLX aligners worn for 7 days, followed by FLX35 aligners for 3 days.
- Keywords
- Orthodontics, Tooth, Movement, Removable, Appliances
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1: FLX aligners for 10 daysDevice
FLX aligners worn for 10 days
Group 3: FLX aligners for 7 days, followed by new FLX aligners for 3 days.Device
Group 3: FLX aligners worn for 7 days, followed by new FLX aligners for 3 days.
Group 2: FLX aligners worn for 7 days, followed by FLX35 aligners for 3 days.Device
Group 2: FLX aligners for 7 days, followed by FLX35 aligners for 3 days.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: FLX aligner 10 days | Active comparator | Participants use the FLX aligner exclusively for 10 days. Receives: Device: Group 1: FLX aligners for 10 days |
| Arm 2: FLX for 10 days + FLX35 for 3 days | Experimental | Participants use the FLX aligner for 7 days, followed by the FLX35 aligner for 3 days. Receives: Device: Group 2: FLX aligners worn for 7 days, followed by FLX35 aligners for 3 days. |
| FLX aligner for 7 days + FLX for 3 days | Experimental | FLX aligner for 7 days, followed by the FLX aligner for 3 days Receives: Device: Group 3: FLX aligners for 7 days, followed by new FLX aligners for 3 days. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tooth movement and predictability achieved by different aligner materials, evaluated through radiographs and intraoral scanning
Digital study models (obtained using an intraoral scanner), along with standardized digital panoramic and periapical radiographs, will be collected at three key stages: before treatment initiation (for diagnosis and planning), during treatment, and immediately after treatment completion (for assessing the results). This follows the standard clinical practice in orthodontic treatment.
The intraoral scans will be analyzed in conjunction with the planned movement models generated by the orthodontic treatment planning software.
To evaluate treatment efficacy, tooth tracking will be performed using Geomagic Control X. This analysis will compare the planned tooth movement (reported in mm) with the actual movement achieved (reported in mm). The planned movement aligns with the expected total. Therefore, the percentage (%) of orthodontic movement successfully completed will be calculated based on the measurements.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start6 Nov 2024
- Primary completionFeb 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalocclusionStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neodent
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06882395
- Sponsor's protocol ID
- CC.2024.Double_Aligner
- Status last verified
- Dec 2024
- First submitted
- 7 Mar 2025
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Aligner Replacement Protocols on Predictability of Planned Dental Movements: Evaluation of Double Aligner
- ClinicalTrials.gov ID
- NCT06882395
- Acronym / sponsor ID
- CC.2024.Double_Aligner
- Conditions
- Malocclusion, Clear Aligner Appliance, Orthodontics, Tooth Movement
- Keywords
- Orthodontics, Tooth, Movement, Removable, Appliances
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 114 participants (actual)
- Lead sponsor
- NeodentIndustry (pharma, biotech, devices)
- Study start
- 6 Nov 2024 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 18 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will evaluate the impact of replacing aligners after 7 days with new aligners made of different materials on the predictability of planned dental movements. Three groups of participants will follow different aligner protocols, and the planned movements will be compared with the achieved ones. The study aims to provide relevant data for clinical practices with orthodontic aligners and assess participants' satisfaction with the treatment.
Detailed description
This prospective clinical trial aims to determine whether replacing an aligner after 7 days with a new aligner of a different material affects the predictability of planned dental movements. A total of 114 adult patients undergoing orthodontic treatment with aligners-requiring bilateral tooth movements (extrusion, intrusion, rotation, tipping, or mesiodistal translation)-will be recruited and randomized into three groups with distinct aligner exchange protocols.
Group 1: 10 days of exclusive FLX aligner use. Group 2: 7 days of FLX aligner use followed by 3 days of FLX35 use. Group 3: 7 days of FLX aligner use followed by 3 days of a new FLX aligner. Within each group, patients will be further categorized into subgroups based on horizontal, vertical, and rotational movements. Digital study models, radiographs, and standardized clinical photographs will be used to compare planned versus achieved tooth movements. The primary outcome is the predictability of movement, defined as the difference and percentage of planned versus actual movement. Secondary outcomes include participant satisfaction measured via the OHIP-14 questionnaire. Data will be analyzed using descriptive statistics and paired tests appropriate for the split-mouth design. The study is conducted in accordance with the Declaration of Helsinki, and all treatment costs will be covered by the sponsor, NeoDent (JJGC Industria e Comercio de Materiais Dentarios S.A.).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1: FLX aligner 10 days | Active comparator | Device: Group 1: FLX aligners for 10 daysParticipants use the FLX aligner exclusively for 10 days. |
| Arm 2: FLX for 10 days + FLX35 for 3 days | Experimental | Device: Group 2: FLX aligners worn for 7 days, followed by FLX35 aligners for 3 days.Participants use the FLX aligner for 7 days, followed by the FLX35 aligner for 3 days. |
| FLX aligner for 7 days + FLX for 3 days | Experimental | Device: Group 3: FLX aligners for 7 days, followed by new FLX aligners for 3 days.FLX aligner for 7 days, followed by the FLX aligner for 3 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18 years or older, with full permanent dentition.
- Interested in orthodontic treatment with aligners.
- Planned movements include extrusion, intrusion, rotation, tipping, or mesiodistal translation.
- Signed informed consent.
Key exclusion criteria (3 listed)
- Contraindications to aligner use, including allergies to polyurethane or PETG.
- Poor oral hygiene or active periodontal disease.
- Malocclusions involving multiple missing teeth or short clinical crowns.
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 |
|---|---|---|
| Group 1: FLX aligners for 10 daysFLX aligners worn for 10 days | Device | Arm 1: FLX aligner 10 days |
| Group 3: FLX aligners for 7 days, followed by new FLX aligners for 3 days.Group 3: FLX aligners worn for 7 days, followed by new FLX aligners for 3 days. | Device | FLX aligner for 7 days + FLX for 3 days |
| Group 2: FLX aligners worn for 7 days, followed by FLX35 aligners for 3 days.Group 2: FLX aligners for 7 days, followed by FLX35 aligners for 3 days. | Device | Arm 2: FLX for 10 days + FLX35 for 3 days |
Primary outcome
Tooth movement and predictability achieved by different aligner materials, evaluated through radiographs and intraoral scanning
Time frame: 7 days
Digital study models (obtained using an intraoral scanner), along with standardized digital panoramic and periapical radiographs, will be collected at three key stages: before treatment initiation (for diagnosis and planning), during treatment, and immediately after treatment completion (for assessing the results). This follows the standard clinical practice in orthodontic treatment. The intraoral scans will be analyzed in conjunction with the planned movement models generated by the orthodontic treatment planning software. To evaluate treatment efficacy, tooth tracking will be performed using Geomagic Control X. This analysis will compare the planned tooth movement (reported in mm) with the actual movement achieved (reported in mm). The planned movement aligns with the expected total. Therefore, the percentage (%) of orthodontic movement successfully completed will be calculated based on the measurements.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group 1: FLX aligners for 10 days, Group 3: FLX aligners for 7 days, followed by new FLX aligners for 3 days. and Group 2: FLX aligners worn for 7 days, followed by FLX35 aligners for 3 days. in people with Malocclusion and Clear Aligner Appliance, run by Neodent at 1 site in Brazil.
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 4 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 21 Mar 2025. 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 Brazil. 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?
This study is still under way. Results are not available in the source record yet.
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?
Tooth movement and predictability achieved by different aligner materials, evaluated through radiographs and intraoral scanning (time frame: 7 days). 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 21 Mar 2025.