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

NCT ID: NCT05773573

Last Updated: 2025-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-22

Study Completion Date

2025-01-15

Brief Summary

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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

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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

Conditions

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Maxillary Hypoplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Experimental group

Hyrax-type rapid maxillary expander anchored on the 2nd deciduous molars (V)

Group Type EXPERIMENTAL

Experimental group

Intervention Type DEVICE

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

Control group

Hyrax-type rapid maxillary expander anchored on the 1st permanent molars (6)

Group Type ACTIVE_COMPARATOR

Control group

Intervention Type DEVICE

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

Interventions

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Experimental group

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

Intervention Type DEVICE

Control group

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre de Soins Dentaires

Montpellier, , France

Site Status

Countries

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France

Other Identifiers

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RECHMPL22_0144

Identifier Type: -

Identifier Source: org_study_id

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