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

Malocclusion, Angle Class I Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06253286
• Other study ID #: FUE.REC (24)/11-2020
• Status: Completed
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: December 1, 2023

Study information

• Verified date: February 2024
• Source: Future University in Egypt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 1, 2023
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Malocclusion
• Malocclusion, Angle Class I

Intervention

Device:
• clear aligner treatment for orthodontics patients
patient are instructed to wear aligners

Locations

Country	Name	City	State
Egypt	Future University in Egypt	Cairo	New Caro

Sponsors (1)

Lead Sponsor	Collaborator
Future University in Egypt

Country where clinical trial is conducted

Egypt, 

References & Publications (22)

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* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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