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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06253286
Enrollment
14
Registered
2024-02-12
Start date
2020-11-01
Completion date
2023-12-01
Last updated
2024-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malocclusion, Angle Class I

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.

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.

Interventions

DEVICEclear aligner treatment for orthodontics patients

patient are instructed to wear aligners

Sponsors

Future University in Egypt
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Intervention model description

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

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Linear Movement Discrepancies Between Digital Software Models and Clinical Modelsan average of 1 yearTranslation movements (mm) were compared for each tooth between predicted models on Software predicted models and actual clinical models for the study groups
Angular Movement Discrepancies Between Digital Software Models and Clinical Modelsan average of 1 yearTranslation movements (Degrees) were compared for each tooth between predicted models on Software predicted models and actual clinical models for the study groups

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026