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Effectiveness of Aligners Versus Rapid Maxillary Expansion

NCT04760535 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-05-25

No results posted yet for this study

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.

Conditions

  • Maxillary Transverse Deficiency (MTD)

Interventions

DEVICE

Invisalign® First Phase I treatment (Align Technology, Inc., Santa Clara, CA, USA)

Subjects in this arm will be instructed to wear aligners 24h/day for entire duration of the therapy. They will be asked to remove their retainers only while eating, drinking (except water), or cleaning. At the time of appliance delivery, both written and verbal oral hygiene instructions were given, including methods for cleaning appliances themselves. Also, written informed consent were obtained for each patient or the parents.

DEVICE

Tooth-borne Hyrax-type maxillary expander

The expansion protocol was one quarter-turn twice a day (0.45 mm activation per day) until overcorrection with the maxillary lingual cusps contacting the mandibular buccal cusps. The expander was left passively for retention for a minimum of 6 months. At the time of appliance delivery, both written and verbal oral hygiene instructions were given, including methods for cleaning appliances themselves. Also, written informed consent were obtained for each patient or the parents.

Sponsors & Collaborators

  • University of Turin, Italy

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-15
Primary Completion
2020-10-15
Completion
2021-05-03

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04760535 on ClinicalTrials.gov