Clinical trial NCT06253286: Predictability of Part-time Wearing of Removable Clear Aligner Therapy Versus Full Time
Official title: Predictability of Part-time Wearing of Removable Clear Aligner Therapy Versus Full Time
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malocclusion, Angle Class I
Lead sponsor: Future University in Egypt
Sponsor class: OTHER
First posted: 2024-02-12
Enrollment: 14
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized controlled clinical trial of 2 parallel groups with an allocation ratio of 1:1
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Linear Movement Discrepancies Between Digital Software Models and Clinical Models
timeFrame: an average of 1 year
measure: Angular Movement Discrepancies Between Digital Software Models and Clinical Models
timeFrame: an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Future University in Egypt
state: New Caro
Study officials:
affiliation: Future University in Egypt
name: Hala Mounir, Prof
role: STUDY_CHAIR
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