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

January 15, 2025 updated by: University Hospital, Montpellier

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

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34090
        • Centre de Soins Dentaires

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 12 years (Child)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
Hyrax-type rapid maxillary expander anchored on the 2nd deciduous molars (V)
Device: Experimental group
The experimental group will have a hyrax rapid maxillary expander anchored on the 2nd deciduous molars (V)
Active Comparator: Control group
Hyrax-type rapid maxillary expander anchored on the 1st permanent molars (6)
Device: Control group
The control group will have a hyrax rapid maxillary expander anchored on the 1st permanent molars (6)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months
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
6 months
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
6 months
Inter-operator reproducibility
Time Frame: 1 month
Inter-operator reproducibility assessed by the intra-class correlation coefficient
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 22, 2023

Primary Completion (Actual)

December 20, 2024

Study Completion (Actual)

January 15, 2025

Study Registration Dates

First Submitted

March 6, 2023

First Submitted That Met QC Criteria

March 6, 2023

First Posted (Actual)

March 17, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 15, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RECHMPL22_0144

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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