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

NCT05773573 | Completed

• 1 other identifier: RECHMPL22_0144
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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)

Conditions

Maxillary Hypoplasia

Keywords

Orthodontic appliances; Orthodontic interceptive; Palatal expansion technique; Child; Dentition mixed; Tooth deciduous; Rapid maxillary expansion

Outcome Measures

Primary Outcomes (1)

• Difference in skeletal maxillary width before/ after rapid maxillary expansion

  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 Outcomes (4)

• 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

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Device: Experimental group

Control group

ACTIVE COMPARATOR

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

Device: Control group

Interventions

Experimental group DEVICE

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

Experimental group

Control group DEVICE

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

Control group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Centre de Soins Dentaires

Montpellier, 34090, France

Location

MeSH Terms

Conditions

Retrognathia

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic Diseases; Mandibular Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: March 17, 2023
• Study Start: May 22, 2023
• Primary Completion: December 20, 2024
• Study Completion: January 15, 2025
• Last Updated: January 17, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)