Maxillary DeficiencyPhase 3NCT00916084
Comparative Results of Maxillary Deficiency Treatment by Fixed Tongue Appliance and Fixed Facemask in Growing Patients
A Phase 3 study testing Fixed Tongue Appliance and Fixed Face Mask in people with Maxillary Deficiency, run by Shahid Beheshti University at 1 site in Iran.
Trial summary
A new fixed appliance will be used to transfer the tongue force during its physiological activity to advance the nasomaxillary complex; this method will be compared with the traditional method which uses a facemask with a fixed appliance in the mouth. Read more about this study
- Who is it for?
- Ages 7 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Maxillary Deficiency
- What is being tested?
- Fixed Tongue Appliance and Fixed Face Mask
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIran
- Study dates
- Jun 2009to Aug 2010
- Phase
- Phase 3
- 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 7 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Growing patients
- Class III with maxillary deficiency
Who cannot join
- Previous orthodontic treatment
- Uncooperative patients
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Shahid Beheshti Medical University
Tehran
Mohammad Behnaz, 09123278021, Behnaz1357@yahoo.com
Mohammad Behnaz, Orthodontist
About this study
Official title: This Study is to Apply the Tongue Force to Correct the Dentofacial Deformities
A new fixed appliance will be used to transfer the tongue force during its physiological activity to advance the nasomaxillary complex; this method will be compared with the traditional method which uses a facemask with a fixed appliance in the mouth.
Read the detailed description
The above method will be compared with traditional one which uses the facemask in combination with an intra-oral fixed appliance.
- Conditions
- Maxillary Deficiency
- Being tested
- Fixed Tongue Appliance, Fixed Face Mask
- Medical subject headings
- Retrognathia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fixed Tongue ApplianceDevice
Also called tongue plate
A functional appliance used for maxillary protraction. It has two bands on first molars, expansion screw and long palatal plate in the canine area which cages the tongue and transfers the force of the tongue during physiological activity to the upper arch.
Fixed Face MaskDevice
Also called face mask
An extra-oral appliance used for treatment of maxillary deficiency in growing patients. It takes anchorage from the chin and forehead, has a fixed intra-oral appliance with an expansion screw and hooks for elastics that exert a force of 300 gr. It should be used 14 hours a day.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Not described Receives: Device: Fixed Tongue Appliance |
| Group B | Experimental | Not described Receives: Device: Fixed Face Mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cephalometric angles and clinical features
Measured: At least 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionApr 2010 (estimated)
- Study completionAug 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maxillary DeficiencyStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University
- Sponsor type
- University, hospital or other
- Investigators
- Rahman Showkatbakhsh, Professor, Study chair, Shaheed Beheshti dental schoolMohammad Behnaz, Principal investigator, Shahid Beheshti Dental school
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00916084
- Sponsor's protocol ID
- behnaz1357
- Status last verified
- Dec 2009
- First submitted
- 8 Jun 2009
- Last updated
- 27 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- This Study is to Apply the Tongue Force to Correct the Dentofacial Deformities
- ClinicalTrials.gov ID
- NCT00916084
- Acronym / sponsor ID
- behnaz1357
- Conditions
- Maxillary Deficiency
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shahid Beheshti UniversityUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Apr 2010 (estimated)
- Study completion
- Aug 2010 (estimated)
- First posted
- 9 Jun 2009 (estimated)
- 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.
A new fixed appliance will be used to transfer the tongue force during its physiological activity to advance the nasomaxillary complex; this method will be compared with the traditional method which uses a facemask with a fixed appliance in the mouth.
Detailed description
The above method will be compared with traditional one which uses the facemask in combination with an intra-oral fixed appliance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: Fixed Tongue Appliance |
| Group B | Experimental | Device: Fixed Face Mask |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Growing patients
- Class III with maxillary deficiency
Key exclusion criteria (2 listed)
- Previous orthodontic treatment
- Uncooperative patients
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 |
|---|---|---|
| Fixed Tongue ApplianceAlso: tongue plateA functional appliance used for maxillary protraction. It has two bands on first molars, expansion screw and long palatal plate in the canine area which cages the tongue and transfers the force of the tongue during physiological activity to the upper arch. | Device | Group A |
| Fixed Face MaskAlso: face maskAn extra-oral appliance used for treatment of maxillary deficiency in growing patients. It takes anchorage from the chin and forehead, has a fixed intra-oral appliance with an expansion screw and hooks for elastics that exert a force of 300 gr. It should be used 14 hours a day. | Device | Group B |
Primary outcome
Cephalometric angles and clinical features
Time frame: At least 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2010.
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Long-Term Stability of Soft and Hard Tissues After Guided Bone Regeneration in the Maxillary Anterior Region
Alveolar Bone Deficiency
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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.
Rahman Showkatbakhsh, Professor study chair
Shaheed Beheshti dental school
Mohammad Behnaz principal investigator
Shahid Beheshti Dental school
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fixed Tongue Appliance and Fixed Face Mask in people with Maxillary Deficiency, run by Shahid Beheshti University at 1 site in Iran.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 27 Jul 2010. 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 Iran. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohammad Behnaz, Orthodontist (09123278021, behnaz1357@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cephalometric angles and clinical features (time frame: At least 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 27 Jul 2010.