Predictability of Part-time Wearing of Removable Clear Aligner Therapy Versus Full Time

Not Applicable

Completed

• Conditions: Malocclusion, Angle Class I
• Interventions: Device: clear aligner treatment for orthodontics patients

• Registration Number: NCT06253286
• Lead Sponsor: Future University in Egypt

Brief Summary

14 Patients with mild to moderate crowding and spacing will be selected according to inclusion criteria.

Treatment planning will be done on Maestro® software. An impression will be taken and scanned by an extra-oral scanner. The models will be 3D printed and aligner trays will be fabricated to be delivered on biweekly basis to be worn 16 hours per day for one group and 22 hours for the other group. Superimposition of the achieved clinical model over the predicted model will be done. Linear and angular measurements will be calculated for each tooth.

Detailed Description

Clear removable retainers could be related to clear aligners. Wearing time of retainers has been suggested that it could be changed from full time to part-time during the night only. A similar approach could be done to determine the effect of wearing time of clear aligners on treatment outcome. The standard duration per day for wearing the appliance is 22 hours. However, is part-time wearing (16 hours) would have the same effect? Therefore, a randomized clinical trial is needed to compare the effect of partial wearing of the aligner versus full time. Moreover, studying the predictability and accuracy of treatment using Maestro software.

Study Timeline

• Study Start: 2020-11-01
• Study First Submitted: 2021-06-27
• Primary Completion: 2022-05-01
• Study Completion: 2023-12-01
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-02
• Last Update Submitted: 2024-02-02
• Study First Posted: 2024-02-12
• Last Update Posted: 2024-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

1. Permeant dentition
2. Mild to moderate crowding and spacing in maxilla and mandible according to Little's Irregularity Index
3. Non-extraction cases

Exclusion Criteria

1. Severe crowding and spacing
2. Systematic diseases
3. Compromised periodontal health
4. Craniofacial syndromes

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
part-time wear	clear aligner treatment for orthodontics patients	Patients will be instructed to wear the aligner for 16 hours per day, then the aligner going to be changed to the next step according to its numerical order in the software
Full-time wear	clear aligner treatment for orthodontics patients	Patients will be instructed to wear the aligner for 22 hours per day, then the aligner going to be changed to the next step according to its numerical order in the software

Primary Outcome Measures

Name	Time	Method
Linear Movement Discrepancies Between Digital Software Models and Clinical Models	an average of 1 year	Translation movements (mm) were compared for each tooth between predicted models on Software predicted models and actual clinical models for the study groups
Angular Movement Discrepancies Between Digital Software Models and Clinical Models	an average of 1 year	Translation movements (Degrees) were compared for each tooth between predicted models on Software predicted models and actual clinical models for the study groups

Trial Locations

Locations (1)

Future University in Egypt; 🇪🇬 Cairo, New Caro, Egypt