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OpenTrials
Completed

NCT Number: NCT06253286

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Future University in Egypt

Cairo, New Caro, 11865, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Severe crowding and spacing
  • Systematic diseases
  • Compromised periodontal health
  • Craniofacial syndromes

Treatment and study plan

clear aligner treatment for orthodontics patients

Device

patient are instructed to wear aligners

Primary outcomes

  1. Linear Movement Discrepancies Between Digital Software Models and Clinical Models

    Time frame: 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

  2. Angular Movement Discrepancies Between Digital Software Models and Clinical Models

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Future University in Egypt

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Feb 12, 2024
Registry last updated
Feb 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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