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

Sponsor
University Hospital, Montpellier (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05773573
Collaborator
(none)
30
1
2
18.1
1.7

Study Details

Study Description

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)

Condition or Disease Intervention/Treatment Phase
  • Device: Experimental group
  • Device: Control group
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
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
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Sep 1, 2024
Anticipated Study Completion Date :
Sep 1, 2024

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

  1. Difference in skeletal maxillary width before/ after rapid maxillary expansion [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

Secondary Outcome Measures

  1. Difference of the inter-molar distance before/after [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

  2. Difference of the inter-canine distance before/after [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

  3. Difference in the amount of molar derotation (inter-molar angle) before/after [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

  4. Inter-operator reproducibility [1 month]

    Inter-operator reproducibility assessed by the intra-class correlation coefficient

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 12 Years
Sexes Eligible for Study:
All
Accepts 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 consent from a parent with parental authority

  • No affiliation to a French national medical health system

  • Patient with a legal protection measure

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre de Soins Dentaires Montpellier France 34090

Sponsors and Collaborators

  • University Hospital, Montpellier

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT05773573
Other Study ID Numbers:
  • RECHMPL22_0144
First Posted:
Mar 17, 2023
Last Update Posted:
Mar 17, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Montpellier

Study Results

No Results Posted as of Mar 17, 2023