Impact of Aligner Replacement Protocols on Predictability of Planned Dental Movements: Evaluation of Double Aligner
NCT ID: NCT06882395
Last Updated: 2025-03-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
114 participants
INTERVENTIONAL
2024-11-06
2027-07-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1: FLX aligner 10 days
Participants use the FLX aligner exclusively for 10 days.
Group 1: FLX aligners for 10 days
FLX aligners worn for 10 days
Arm 2: FLX for 10 days + FLX35 for 3 days
Participants use the FLX aligner for 7 days, followed by the FLX35 aligner 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.
FLX aligner for 7 days + FLX for 3 days
FLX aligner for 7 days, followed by the FLX aligner for 3 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.
Interventions
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Group 1: FLX aligners for 10 days
FLX aligners worn for 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.
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.
Eligibility Criteria
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Inclusion Criteria
* Interested in orthodontic treatment with aligners.
* Planned movements include extrusion, intrusion, rotation, tipping, or mesiodistal translation.
* Signed informed consent.
Exclusion Criteria
* Poor oral hygiene or active periodontal disease.
* Malocclusions involving multiple missing teeth or short clinical crowns.
18 Years
ALL
Yes
Sponsors
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Neodent
INDUSTRY
Responsible Party
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Locations
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Private orthodontic clinic
Curitba, Paraná, Brazil
Countries
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Other Identifiers
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CC.2024.Double_Aligner
Identifier Type: -
Identifier Source: org_study_id
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