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Skeletal and Dental Changes with Hyrax-type Rapid Maxillary Expander Anchored to Permanent Versus Deciduous Molars (DENTHYRAX)

University Hospital Center (CHU) logo

University Hospital Center (CHU)

Status

Completed

Conditions

Maxillary Hypoplasia

Treatments

Device: Control group
Device: Experimental group

Study type

Interventional

Funder types

Other

Identifiers

NCT05773573
RECHMPL22_0144

Details and patient eligibility

About

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)

Full 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

Enrollment

34 patients

Sex

All

Ages

6 to 12 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

34 participants in 2 patient groups

Experimental group
Experimental group
Description:
Hyrax-type rapid maxillary expander anchored on the 2nd deciduous molars (V)
Treatment:
Device: Experimental group
Control group
Active Comparator group
Description:
Hyrax-type rapid maxillary expander anchored on the 1st permanent molars (6)
Treatment:
Device: Control group

Trial contacts and locations

1

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Central trial contact

Leila ELOTMANI; Stéphane BARTHELEMI, MD, PhD

Data sourced from clinicaltrials.gov

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