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

NCT06253286 | Completed

• 1 other identifier: FUE.REC (24)/11-2020
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Malocclusion, Angle Class I

Outcome Measures

Primary Outcomes (2)

• Linear Movement Discrepancies Between Digital Software Models and Clinical Models

  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

  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

Study Arms (2)

part-time wear

ACTIVE COMPARATOR

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

Full-time wear

ACTIVE COMPARATOR

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

Interventions

clear aligner treatment for orthodontics patients DEVICE

patient are instructed to wear aligners

Full-time wear; part-time wear

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Future University in Egypt: lead

Study Sites (1)

Future University in Egypt

Cairo, New Caro, 11865, Egypt

Location

Related Publications (22)

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MeSH Terms

Conditions

Malocclusion, Angle Class I

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Hala Mounir, Prof

  Future University in Egypt

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: A randomized controlled clinical trial of 2 parallel groups with an allocation ratio of 1:1

Study Record Dates

• First Submitted: June 27, 2021
• First Posted: February 12, 2024
• Study Start: November 1, 2020
• Primary Completion: May 1, 2022
• Study Completion: December 1, 2023
• Last Updated: February 12, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available after publication, indefinitely
• Access Criteria: Professors of other institutions will have access to the data if required via email

Locations

EG (1)