Skip to main content
OpenTrials
Completed

NCT Number: NCT05773573

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

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)

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Maxillary Hypoplasia Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Jaw Abnormalities Jaw Diseases Mandibular Diseases Maxillofacial Abnormalities Musculoskeletal Abnormalities Musculoskeletal Diseases Retrognathia Stomatognathic Diseases Stomatognathic System Abnormalities

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre de Soins Dentaires

Montpellier, 34090, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Experimental Group

Device

The experimental group will have a hyrax rapid maxillary expander anchored on the 2nd deciduous molars (V)

Control group

Device

The control group will have a hyrax rapid maxillary expander anchored on the 1st permanent molars (6)

Primary outcomes

  1. 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

  1. Difference of the inter-molar distance before/after

    Time frame: 6 months

    Difference before (V0) / after (V8) rapid maxillary expansion with tooth-borne expander type Hyrax of the inter-molar distance (mesiopalatal cusp) assessed on dental casts

  2. Difference of the inter-canine distance before/after

    Time frame: 6 months

    Difference before (V0) / after (V8) rapid maxillary expansion with tooth-borne expander type Hyrax of the inter-canine distance (cuspids cusp) assessed on dental casts

  3. Difference in the amount of molar derotation (inter-molar angle) before/after

    Time frame: 6 months

    Difference before (V0) / after (V8) rapid maxillary expansion with tooth-borne expander type Hyrax in the amount of molar derotation (inter-molar angle) assessed on dental casts

  4. Inter-operator reproducibility

    Time frame: 1 month

    Inter-operator reproducibility assessed by the intra-class correlation coefficient

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Acronym: DENTHYRAX

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Mar 17, 2023
Registry last updated
Jan 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.