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

NCT ID: NCT06253286

Last Updated: 2024-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-01

Study Completion Date

2023-12-01

Brief Summary

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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

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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.

Conditions

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Malocclusion, Angle Class I

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A randomized controlled clinical trial of 2 parallel groups with an allocation ratio of 1:1
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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

Group Type ACTIVE_COMPARATOR

clear aligner treatment for orthodontics patients

Intervention Type DEVICE

patient are instructed to wear aligners

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

Group Type ACTIVE_COMPARATOR

clear aligner treatment for orthodontics patients

Intervention Type DEVICE

patient are instructed to wear aligners

Interventions

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clear aligner treatment for orthodontics patients

patient are instructed to wear aligners

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Future University in Egypt

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Adel Zein

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hala Mounir, Prof

Role: STUDY_CHAIR

Future University in Egypt

Locations

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Future University in Egypt

Cairo, New Caro, Egypt

Site Status

Countries

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Egypt

References

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Study Documents

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Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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FUE.REC (24)/11-2020

Identifier Type: -

Identifier Source: org_study_id

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