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Clinical Trials/NCT05773573
NCT05773573
Completed
Not Applicable

Comparison of Skeletal and Dental Changes with Hyrax-type Rapid Maxillary Expander Anchored to Permanent (6) Versus Deciduous Molars (V) in Growing Subjects

University Hospital, Montpellier1 site in 1 country34 target enrollmentMay 22, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Maxillary Hypoplasia
Sponsor
University Hospital, Montpellier
Enrollment
34
Locations
1
Primary Endpoint
Difference in skeletal maxillary width before/ after rapid maxillary expansion
Status
Completed
Last Updated
last year

Overview

Brief Summary

The aim of the study is to compare the skeletal and dental maxillary expansion obtained with an Hyrax tooth-borne expander anchored either on the 2nd deciduous molars (V) or on the 1st permanent molars (6)

Detailed Description

The aim of the study is to compare the skeletal and dental maxillary expansion obtained with an Hyrax tooth-borne expander anchored either on the 2nd deciduous molars (V) or on the 1st permanent molars (6). The main objective is to compare at the skeletal level the distance between the cephalometric points, right jugal (RJ) and left jugal (JR) (maxillary base). The secondaries objectives are performed at the dental level by measuring the distance between the maxillary first molars mesio-palatal cusp and the cuspids cups. Molar derotation is also assessed

Registry
clinicaltrials.gov
Start Date
May 22, 2023
End Date
January 15, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patient coming to the dental clinic for a first orthodontic consultation in mixed dentition
  • Patient aged 6 to 12 years
  • Patient with a transverse maxillary deficiency requiring rapid maxillary expansion
  • Presence of 1st permanent molars "6" and 2nd deciduous "V" molars with sufficient root length

Exclusion Criteria

  • Syndromic patients (all syndromes combined: cleft lip, etc.)
  • Patient with V or 6 with decays (or with major root resorption)
  • Patient with oral hygiene non compatible with orthodontic treatment
  • Failure to obtain informed written consent
  • No affiliation to a French national medical health system
  • Patient with a legal protection measure

Outcomes

Primary Outcomes

Difference in skeletal maxillary width before/ after rapid maxillary expansion

Time Frame: 6 months

Difference in skeletal maxillary width measured on frontal cephs (distance between the cephalometric points "right jugal RJ" and "left jugal JR" of the Ricketts analysis) before (V0)/after (V8) rapid maxillary expansion with tooth-borne expander type Hyrax

Secondary Outcomes

  • Difference of the inter-molar distance before/after(6 months)
  • Difference of the inter-canine distance before/after(6 months)
  • Difference in the amount of molar derotation (inter-molar angle) before/after(6 months)
  • Inter-operator reproducibility(1 month)

Study Sites (1)

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