NCT06882395

Impact of Aligner Replacement Protocols on Predictability of Planned Dental Movements: Evaluation of Double Aligner

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 114 (actual)
• Sponsor: Neodent · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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. 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.).

Conditions

• Malocclusion
• Clear Aligner Appliance
• Orthodontics
• Tooth Movement

Interventions

Type	Name	Description
DEVICE	Group 1: FLX aligners for 10 days	FLX aligners worn for 10 days
DEVICE	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	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.

Timeline

• Start date: 2024-11-06
• Primary completion: 2027-02-01
• Completion: 2027-07-01
• First posted: 2025-03-18
• Last updated: 2025-03-21

Locations

1 site across 1 country: Brazil