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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05773573
Acronym
DENTHYRAX
Enrollment
34
Registered
2023-03-17
Start date
2023-05-22
Completion date
2025-01-15
Last updated
2025-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Maxillary Hypoplasia

Keywords

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

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)

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

Interventions

DEVICEExperimental group

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

DEVICEControl group

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

Sponsors

University Hospital, Montpellier
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Difference in skeletal maxillary width before/ after rapid maxillary expansion6 monthsDifference 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

MeasureTime frameDescription
Difference of the inter-molar distance before/after6 monthsDifference before (V0) / after (V8) rapid maxillary expansion with tooth-borne expander type Hyrax of the inter-molar distance (mesiopalatal cusp) assessed on dental casts
Difference of the inter-canine distance before/after6 monthsDifference before (V0) / after (V8) rapid maxillary expansion with tooth-borne expander type Hyrax of the inter-canine distance (cuspids cusp) assessed on dental casts
Difference in the amount of molar derotation (inter-molar angle) before/after6 monthsDifference 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
Inter-operator reproducibility1 monthInter-operator reproducibility assessed by the intra-class correlation coefficient

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026