Impact of Aligner Replacement Protocols on Predictability of Planned Dental Movements: Evaluation of Double Aligner
Study Overview
Status
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Paraná
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Curitba, Paraná, Brazil, 81270-200
- Private orthodontic clinic
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Arm 1: FLX aligner 10 days
Participants use the FLX aligner exclusively for 10 days.
|
FLX aligners worn for 10 days
|
|
Experimental: 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 for 7 days, followed by FLX35 aligners for 3 days.
|
|
Experimental: 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 worn for 7 days, followed by new FLX aligners for 3 days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
7 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CC.2024.Double_Aligner
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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