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

F

Future University in Egypt

Status

Completed

Conditions

Malocclusion, Angle Class I

Treatments

Device: clear aligner treatment for orthodontics patients

Study type

Interventional

Funder types

Other

Identifiers

NCT06253286
FUE.REC (24)/11-2020

Details and patient eligibility

About

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.

Full 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.

Enrollment

14 patients

Sex

All

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

14 participants in 2 patient groups

part-time wear
Active Comparator group
Description:
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
Treatment:
Device: clear aligner treatment for orthodontics patients
Full-time wear
Active Comparator group
Description:
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
Treatment:
Device: clear aligner treatment for orthodontics patients

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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