Status:
COMPLETED
Effectiveness of Aligners Versus Rapid Maxillary Expansion
Lead Sponsor:
University of Turin, Italy
Conditions:
Maxillary Transverse Deficiency (MTD)
Eligibility:
All Genders
6-10 years
Phase:
NA
Brief Summary
Aim of the study is to assess the effectiveness of Invisalign® First clear aligners compared to tooth-borne Hyrax-type maxillary expander on palatal morphology in growing subjects using 3D technology.
Detailed Description
Aim of the study is to assess the effectiveness of Invisalign® First clear aligners compared to tooth-borne Hyrax-type maxillary expander on palatal morphology in growing subjects using 3D technology....
Eligibility Criteria
Inclusion
- patients who have been diagnosed with transverse maxillary deficiency;
- mixed dentition phase with cervical vertebral maturation stage (CVMS) less than 4;
- fully erupted upper and lower first molars;
- transversal discrepancy ≤5mm
- demonstration of a good standard of oral hygiene (determined through questioning and clinical examination);
- subjects willing to consent to the trial and comply with the trial regime.
Exclusion
- any general medical health problems which may influence gingival health, such as those necessitating antibiotic cover as bacteremia prophylaxis, diabetes mellitus, epilepsy, or physical or mental disability;
- permanent teeth extraction-based treatment (third molars excluded);
- morphologic crown anomalies;
- auxiliary treatment during arch expansion stage (such as crossbite elastics);
- posterior interproximal reduction;
- orthognathic surgery treatment planned;
- cleft palate or severe facial deformities.
Key Trial Info
Start Date :
January 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 3 2021
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04760535
Start Date
January 15 2019
End Date
May 3 2021
Last Update
May 25 2022
Active Locations (1)
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1
University of Turin
Turin, Italy, 10126