The Efficiency of Clear Aligners in Maxillary Molar Distalization: A Randomized Clinical Trial.
Aligner
The Accuracy of Clear Aligners in Maxillary Molar Distalization With and Without Attachments: A Randomized Clinical Trial.
1 other identifier
interventional
10
1 country
1
Brief Summary
The aim of this study is to evaluate the accuracy of clear aligners on the amount of the maxillary molar distalization.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 17, 2022
CompletedFirst Posted
Study publicly available on registry
March 26, 2024
CompletedStudy Start
First participant enrolled
April 27, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 15, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 15, 2025
CompletedMarch 26, 2024
July 1, 2023
9 months
March 17, 2022
March 19, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Efficiency of aligners in molar distalization
T2(3shape)-T1(actual) \<mm\>
6 months
Secondary Outcomes (2)
Amount of anchorage loss
6 months
Amount of molar tipping
6 months
Study Arms (2)
Molar distalization by aligners without attachment
ACTIVE COMPARATORMolar distalization by aligners with attachments
EXPERIMENTALInterventions
1. Plaster dental models will be poured from the rubber base impression. 2. Digital dental models will be created through scanning of plaster dental models. 3. Planning of the aligners will be done on 3 shape clear aligner. 4. Aligners will be fabricated on 3d printed models. 5. Patient will receive the first aligner and will be instructed to wear it full time (except during eating and brushing) for 2 weeks. 6. Patient will receive the following aligner after 2 weeks. 7. Follow up visits every 4weeks until 6 months.
Eligibility Criteria
You may qualify if:
- Age more than15 years.
- Gender; male or female.
- Skeletal Class I or Class II malocclusion and a bilateral half-cusp class II molar relationship that require molar distalization.
- Mild crowding in the upper arch (≤ 4 mm).
- Absence or previous extraction of the upper third molars.
- Good compliance during the treatment
You may not qualify if:
- Transversal dental or skeletal discrepancies.
- Extraction treatment (except for the third molar).
- Periodontal disease. .
- Prosthodontics rehabilitation of the maxillary molars.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ainshams university
Cairo, Egypt
Study Officials
- STUDY CHAIR
Noha E Sabet, Prof
Ain Shams University
- STUDY DIRECTOR
Marwa s Abdelatef, Phd
Ain Shams University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 17, 2022
First Posted
March 26, 2024
Study Start
April 27, 2024
Primary Completion
January 15, 2025
Study Completion
July 15, 2025
Last Updated
March 26, 2024
Record last verified: 2023-07