Maxillary HypoplasiaDENTHYRAXNCT05773573
Skeletal and Dental Changes with Hyrax-type Rapid Maxillary Expander Anchored to Permanent Versus Deciduous Molars
A study testing Experimental group in people with Maxillary Hypoplasia, run by University Hospital, Montpellier at 1 site in France.
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) Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Maxillary Hypoplasia
- What is being tested?
- Experimental group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteFrance
- Study dates
- 22 May 2023to 15 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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)
Read the 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
- Conditions
- Maxillary Hypoplasia
- Being tested
- Experimental group, Control group
- Keywords
- Orthodontic appliances, Orthodontic interceptive, Palatal expansion technique, Child, Dentition mixed, Tooth deciduous, Rapid maxillary expansion
- Medical subject headings
- Retrognathia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental groupDevice
The experimental group will have a hyrax rapid maxillary expander anchored on the 2nd deciduous molars (V)
Control groupDevice
The control group will have a hyrax rapid maxillary expander anchored on the 1st permanent molars (6)
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Hyrax-type rapid maxillary expander anchored on the 2nd deciduous molars (V) Receives: Device: Experimental group |
| Control group | Active comparator | Hyrax-type rapid maxillary expander anchored on the 1st permanent molars (6) Receives: Device: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (4)
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
Measured: 6 months
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
Measured: 6 months
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
Measured: 6 months
Inter-operator reproducibility
Inter-operator reproducibility assessed by the intra-class correlation coefficient
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2023
- Study start22 May 2023
- Primary completion20 Dec 2024
- Study completion15 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maxillary HypoplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05773573
- Sponsor's protocol ID
- RECHMPL22_0144
- Acronym
- DENTHYRAX
- Status last verified
- Jan 2025
- First submitted
- 6 Mar 2023
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05773573
- Acronym / sponsor ID
- DENTHYRAX / RECHMPL22_0144
- Conditions
- Maxillary Hypoplasia
- Keywords
- Orthodontic appliances, Orthodontic interceptive, Palatal expansion technique, Child, Dentition mixed, Tooth deciduous, Rapid maxillary expansion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 22 May 2023 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 17 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: Experimental groupHyrax-type rapid maxillary expander anchored on the 2nd deciduous molars (V) |
| Control group | Active comparator | Device: Control groupHyrax-type rapid maxillary expander anchored on the 1st permanent molars (6) |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental groupThe experimental group will have a hyrax rapid maxillary expander anchored on the 2nd deciduous molars (V) | Device | Experimental group |
| Control groupThe control group will have a hyrax rapid maxillary expander anchored on the 1st permanent molars (6) | Device | Control group |
Primary outcome
Difference in skeletal maxillary width before/ after rapid maxillary expansion
Time frame: 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
4 secondary outcomes
Difference of the inter-molar distance before/after
Time frame: 6 months
Difference of the inter-canine distance before/after
Time frame: 6 months
Difference in the amount of molar derotation (inter-molar angle) before/after
Time frame: 6 months
Inter-operator reproducibility
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental group in people with Maxillary Hypoplasia, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in skeletal maxillary width before/ after rapid maxillary expansion (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2025.