An interventional study of Group 1: FLX aligners for 10 days and Group 3: FLX aligners for 7 days, followed by new FLX aligners for 3 days. in Malocclusion, Clear Aligner Appliance and Orthodontics, sponsored by Neodent. Active, not recruiting at 1 site in Brazil. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-21.
Sponsored by Neodent (part of Institut Straumann AG) · Not applicable, Interventional, and Treatment
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Among 16 studies in Malocclusion with a site in Brazil — 1 open to participants now, 3 under way, none of them phase 3. Malocclusion · Brazil.
Among the 16 studies in Malocclusion with a site in Brazil, this one has the largest enrollment of the 14 interventional ones that give a count, is one of 2 that started in 2024, is one of 12 with no phase, and was the 15th registered.
323 studies on the registry are indexed under Malocclusion; 84 are open to participants now.
Browse Malocclusion studies →1 of the 16 studies in Malocclusion with a site in Brazil is open now. Recruiting first, the newest first:
Neodent · Sites in Brazil
Ages 18+ · Healthy volunteers
A study can be open while its sites in Brazil have not opened yet or have stopped. Only those recruiting at a site in Brazil →
Of the 41 Malocclusion studies recruiting now, 8 (20%) set no upper age limit and 33 (80%) stop at 75 or younger; 32 take children under 18; 18 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
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16 studies; the count open now beside each. This study's row is marked.
First in 2008; this study’s year is marked. 2 started in 2024.
This study's enrollment of 114 is above the median of 37 across 242 interventional studies indexed under Malocclusion.
Median enrollment 36 across the 14 interventional studies, 32 across the 2 observational. Of the 13 that completed or were terminated, 2 (15%) have results posted.
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2 of 16 have an industry lead sponsor. The 10 most frequent:
This study is registered under Neodent, one of the names counted as Institut Straumann AG. Under that name alone:
Neodent is the lead sponsor of 10 studies on the registry; 4 are open to participants now.
Institut Straumann AG has 2 studies filed under Malocclusion — fewer than ten, so there is no comparison to draw.
2 of the studies in Malocclusion with a site in Brazil that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06882395NeodentImpact of Aligner Replacement Protocols on Predictability of Planned Dental Movements: Evaluation of Double Aligner | 2027-02 |
| NCT06873932NeodentEfficacy of Orthodontic Tooth Movement Using Beveled and Conventional Attachments in Aligners | 2027-02 |
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Among the 16 studies in Malocclusion with a site in Brazil, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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.).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants use the FLX aligner exclusively for 10 days.
Device: Group 1: FLX aligners for 10 days
Participants use the FLX aligner for 7 days, followed by the FLX35 aligner for 3 days.
Device: Group 2: FLX aligners worn for 7 days, followed by FLX35 aligners for 3 days.
FLX aligner for 7 days, followed by the FLX aligner for 3 days
Device: Group 3: FLX aligners for 7 days, followed by new FLX aligners for 3 days.
FLX aligners worn for 10 days
Group 3: FLX aligners worn for 7 days, followed by new FLX aligners for 3 days.
Group 2: FLX aligners for 7 days, followed by FLX35 aligners for 3 days.
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.
Time frame: 7 days
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2024 (actual). Primary completion is estimated for Feb 2027, 27 months after the start.
Of 163 interventional studies with no phase under Malocclusion, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 32. This study's planned 27 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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