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

February 2, 2024 updated by: Mohamed Adel Zein, Future University in Egypt

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • New Caro
      • Cairo, New Caro, Egypt, 11865
        • Future University in Egypt

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: part-time wear
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
Device: clear aligner treatment for orthodontics patients
patient are instructed to wear aligners
Active Comparator: Full-time wear
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
Device: clear aligner treatment for orthodontics patients
patient are instructed to wear aligners

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
an average of 1 year
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
an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Future University in Egypt

Investigators

  • Study Chair: Hala Mounir, Prof, Future University in Egypt

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2020

Primary Completion (Actual)

May 1, 2022

Study Completion (Actual)

December 1, 2023

Study Registration Dates

First Submitted

June 27, 2021

First Submitted That Met QC Criteria

February 2, 2024

First Posted (Actual)

February 12, 2024

Study Record Updates

Last Update Posted (Actual)

February 12, 2024

Last Update Submitted That Met QC Criteria

February 2, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FUE.REC (24)/11-2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The trial results will be available to the participants, health care professionals and the public by publication of the study in high quality national and international journals. The principal investigator will present a copy of the thesis at the Faculty of Oral and Dental Medicine, Future University in Egypt library and will distribute additional copies among the main universities in Egypt.

IPD Sharing Time Frame

Data will be available after publication, indefinitely

IPD Sharing Access Criteria

Professors of other institutions will have access to the data if required via email

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Study Data/Documents

  1. Study Protocol
  2. Informed Consent Form

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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