Gnathic (Skeletal) Mesial OcclusionNCT05173402
Treating Gnathic Form of Mesial Occlusion in Early Adolescence Patients
An observational study of Gnathic (Skeletal) Mesial Occlusion, run by The 108 Military Central Hospital.
Trial summary
The primary purpose of this study was to evaluate the immediate and previous results of the effectiveness of non-surgical orthopedic treatment in children aged 12-14 years with gnathic forms of mesial occlusion by the method of dentoalveolar compensation using a permanent apparatus with a palatal expanding screw. Read more about this study
- Who is it for?
- Ages 12 to 14 years
- Conditions the study is for
- Gnathic (Skeletal) Mesial Occlusion
- What is being tested?
- dentoalveolar compensation method and face mask
- Type of treatment
- Medical device
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- 5 Sep 2014to 5 Oct 2020
- Phase
- Observational
- 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 12 to 14 years
- All sexes
- No healthy volunteers
- Child
Study population: To evaluate the early and late results of the non-surgical orthopedic treatment efficiency in 12-14 years old children with the gnathic forms of mesial occlusion by the dentoalveolar compensation utilizing a permanent device with a palatal expanding screw.
Who may be able to join
- patients with a gnathic (skeletal) mesial occlusion patients age 12-14 years patients who underwent orthopedic treatment
Who cannot join
- change of residence severe form of gnathic mesial occlusion congenital anomalies of the dento-maxillo-facial area
About this study
Official title: Treating Gnathic Form of Mesial Occlusion in Early Adolescence Patients: A Clinical Trial
The primary purpose of this study was to evaluate the immediate and previous results of the effectiveness of non-surgical orthopedic treatment in children aged 12-14 years with gnathic forms of mesial occlusion by the method of dentoalveolar compensation using a permanent apparatus with a palatal expanding screw.
- Conditions
- Gnathic (Skeletal) Mesial Occlusion
- Being tested
- dentoalveolar compensation method, face mask
- Keywords
- early adolescence, orthodontic practice, orthodontic treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dentoalveolar compensation methodDevice
orthopedic treatment was performed using the dentoalveolar compensation method with permanent apparatus with a palatal expanding screw
face maskDevice
orthopedic treatment was performed using a face mask.
| Study group | Role | What they receive |
|---|---|---|
| The experimental group | The experimental group included 26 patients - orthopedic treatment was performed using the dentoalveolar compensation method with permanent apparatus with a palatal expanding screw. Receives: Device: dentoalveolar compensation method | |
| The comparison group | The comparison group included 20 patients - orthopedic treatment was performed using a face mask. Receives: Device: face mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
dentoalveolar compensation method
orthopedic treatment was performed using the dentoalveolar compensation method with permanent apparatus with a palatal expanding screw
Measured: 2014-2020
face mask
orthopedic treatment was performed using a face mask
Measured: 2014-2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study start5 Sep 2014
- Primary completion5 Oct 2020
- Study completion5 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gnathic (Skeletal) Mesial OcclusionStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- The 108 Military Central Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Le Thi Thu Hai, The 108 Military Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05173402
- Sponsor's protocol ID
- Le Thi Thu Hai
- Status last verified
- Dec 2021
- First submitted
- 14 Dec 2021
- Last updated
- 29 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study was anonymous. No personal data will be revealed
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Gnathic Form of Mesial Occlusion in Early Adolescence Patients: A Clinical Trial
- ClinicalTrials.gov ID
- NCT05173402
- Acronym / sponsor ID
- Le Thi Thu Hai
- Conditions
- Gnathic (Skeletal) Mesial Occlusion
- Keywords
- early adolescence, orthodontic practice, orthodontic treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- The 108 Military Central HospitalOther government
- Study start
- 5 Sep 2014 (actual)
- Primary completion
- 5 Oct 2020 (actual)
- Study completion
- 5 Oct 2020 (actual)
- First posted
- 29 Dec 2021 (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 primary purpose of this study was to evaluate the immediate and previous results of the effectiveness of non-surgical orthopedic treatment in children aged 12-14 years with gnathic forms of mesial occlusion by the method of dentoalveolar compensation using a permanent apparatus with a palatal expanding screw.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The experimental group | – | Device: dentoalveolar compensation methodThe experimental group included 26 patients - orthopedic treatment was performed using the dentoalveolar compensation method with permanent apparatus with a palatal expanding screw. |
| The comparison group | – | Device: face maskThe comparison group included 20 patients - orthopedic treatment was performed using a face mask. |
Who may qualify
- Ages
- 12 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- To evaluate the early and late results of the non-surgical orthopedic treatment efficiency in 12-14 years old children with the gnathic forms of mesial occlusion by the dentoalveolar compensation utilizing a permanent device with a palatal expanding screw.
Key inclusion criteria (1 listed)
- patients with a gnathic (skeletal) mesial occlusion patients age 12-14 years patients who underwent orthopedic treatment
Key exclusion criteria (1 listed)
- change of residence severe form of gnathic mesial occlusion congenital anomalies of the dento-maxillo-facial area
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 |
|---|---|---|
| dentoalveolar compensation methodorthopedic treatment was performed using the dentoalveolar compensation method with permanent apparatus with a palatal expanding screw | Device | The experimental group |
| face maskorthopedic treatment was performed using a face mask. | Device | The comparison group |
Primary outcome
dentoalveolar compensation method
Time frame: 2014-2020
orthopedic treatment was performed using the dentoalveolar compensation method with permanent apparatus with a palatal expanding screw
face mask
Time frame: 2014-2020
orthopedic treatment was performed using a face mask
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 29 Dec 2021.
- Individual participant dataSharing planned: No. The study was anonymous. No personal data will be revealed
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Gnathic (Skeletal) Mesial Occlusion, run by The 108 Military Central Hospital.
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 1 inclusion and 1 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 29 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
dentoalveolar compensation method (time frame: 2014-2020). The study lists 2 primary outcomes in all. 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 29 Dec 2021.