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Clinical Trials/NCT05773573
NCT05773573CompletedNot 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, Montpellier2 sites in 1 country34 target enrollmentStarted: May 22, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
34
Locations
2
Primary Endpoint
Difference in skeletal maxillary width before/ after rapid maxillary expansion

Study 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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
6 Years to 12 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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