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

NCT06882395 | Active Not Recruiting

• 1 other identifier: CC.2024.Double_Aligner
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Malocclusion; Clear Aligner Appliance; Orthodontics; Tooth Movement

Keywords

Orthodontics; Tooth; Movement; Removable; Appliances

Outcome Measures

Primary Outcomes (1)

• 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.

  7 days

Study Arms (3)

Arm 1: FLX aligner 10 days

ACTIVE COMPARATOR

Participants use the FLX aligner exclusively for 10 days.

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.

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

Device: Group 3: FLX aligners for 7 days, followed by new FLX aligners for 3 days.

Interventions

Group 1: FLX aligners for 10 days DEVICE

FLX aligners worn for 10 days

Arm 1: FLX aligner 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.

FLX aligner for 7 days + FLX 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.

Arm 2: FLX for 10 days + FLX35 for 3 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Neodent: lead

Study Sites (1)

Private orthodontic clinic

Curitba, Paraná, 81270-200, Brazil

Location

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2025
• First Posted: March 18, 2025
• Study Start: November 6, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: March 21, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)