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

Maxillary Hypoplasia Clinical Trial

— DENTHYRAX  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05773573
• Other study ID #: RECHMPL22_0144
• Status: Recruiting
• Phase: N/A
• Start date: May 22, 2023
• Est. completion date: September 2024

Study information

• Verified date: June 2023
• Source: University Hospital, Montpellier
• Contact: Leila ELOTMANI
• Phone: 467336710
• Email: l-elotmani[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Maxillary Hypoplasia

Intervention

Device:
• Experimental group
The experimental group will have a hyrax rapid maxillary expander anchored on the 2nd deciduous molars (V)
• Control group
The control group will have a hyrax rapid maxillary expander anchored on the 1st permanent molars (6)

Locations

Country	Name	City	State
France	Centre de Soins Dentaires	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Difference of the inter-molar distance before/after	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
Secondary	Difference of the inter-canine distance before/after	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
Secondary	Difference in the amount of molar derotation (inter-molar angle) before/after	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
Secondary	Inter-operator reproducibility	Inter-operator reproducibility assessed by the intra-class correlation coefficient	1 month