Tooth Position AnomaliesNCT05371691
A Comparison of the Effectiveness of Two Types of Myofunctional Appliances
A study testing Myofunctional appliance in people with Tooth Position Anomalies, run by University of Baghdad at 2 sites in Iraq.
Trial summary
A randomized clinical trial is set out to compare the effectiveness of two types of functional appliances in the correction of a Class II malocclusion. (Class II malocclusions are where upper front teeth bite significantly further forward in relation to lower front teeth). Read more about this study
- Who is it for?
- Ages 8 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Position Anomalies
- What is being tested?
- Myofunctional appliance
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesIraq
- Study dates
- 10 Sep 2021to 10 Aug 2024
- 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 8 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Growing children who need myofunctional appliance.
- Cl II div. 1 malocclusion.
- No previous orthodontic or orthopaedic treatments.
Who cannot join
- Patients with systemic involvement.
- Congenital malformations such as cleft lip and palate.
- Facial deformities.
- Finger sucking habit will be excluded
Trial locations and contacts
2 sites in 1 country.
Mushriq Abid contact
Iraq2 sites, 2 recruiting
- Recruiting
College of Dentistry-University of Baghdad
Baghdad, Al-Rusafa, 01110
Mushriq Abid
- Recruiting
College of Dentisry-University of Baghdad
Baghdad
Mushriq Abid, PhD
About this study
Official title: A Comparison of the Effectiveness of Two Types of Myofunctional Appliances: A Randomized Clinical Trial
A randomized clinical trial is set out to compare the effectiveness of two types of functional appliances in the correction of a Class II malocclusion. (Class II malocclusions are where upper front teeth bite significantly further forward in relation to lower front teeth).
Read the detailed description
It is a multicenter randomized clinical trial with two arms parallel group. The patients will be randomly divided into two groups, group one: Myobrace appliance will be used while, and group two Twin-block appliances will be used. Cephalometric x-ray will be taken before starting the treatment (T1) and at the end of treatment (T2) at 9 months. The effectiveness of the two appliances will be assessed and measured comparing the difference in the cephalometric X-ray before and after treatment.
- Conditions
- Tooth Position Anomalies
- Being tested
- Myofunctional appliance
- Keywords
- Myofunctional appliance, Myobrace., Twin-block, Cl II div I malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myofunctional applianceDevice
Myifunctional appliance will be used for growing patients who have Cl.II div.1 malocclusion, two types of appliances are involved myobrace and twin=block appliance
| Study group | Role | What they receive |
|---|---|---|
| Myobrace group | Experimental | Myobrace appliance will be used for children who have Cl.II div.a malocclusion Receives: Device: Myofunctional appliance |
| Twin-block group | Experimental | Twin-block appliance will be used for children who have Cl.II div.a malocclusion Receives: Device: Myofunctional appliance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dentoskeletal changes
Evaluation of dentoskeletal and soft tissue changes following the treatment of growing children with myobrace and twin block appliances. Using cephalometric analysis to measure the angles including dental angles such as inter-incisal angle, in addition to skeletal angles such as SNA,SNB and ANB angles.
Measured: T1 at the start of treatment and T2 at the end of treatment around 9 months
Secondary outcomes (2)
Soft tissue changes
- Soft tissue changes using cephalometric radiographs including different angular measurement such as E-line and nasolabial angle (comparing the changes in the photographs at the beginning of the treatment and at the end of the treatment.
Measured: T1 at the start of treatment and T2 at the end of treatment around 9 months
Patient satisfaction
3.Patient satisfaction with both appliances will be investigated using a questionnaire at the end of the study (around 9 months)
Measured: At the end of treatment (around 9 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2022
- Study start10 Sep 2021
- Primary completion10 Jul 2024 (estimated)
- Study completion10 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth Position AnomaliesStudies of the same condition, open and under way.
- More trials run by University of BaghdadThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mushriq F. Abid, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05371691
- Sponsor's protocol ID
- 387421
- Status last verified
- Nov 2023
- First submitted
- 26 Apr 2022
- Last updated
- 28 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Effectiveness of Two Types of Myofunctional Appliances: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05371691
- Acronym / sponsor ID
- 387421
- Conditions
- Tooth Position Anomalies
- Keywords
- Myofunctional appliance, Myobrace., Twin-block, Cl II div I malocclusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 10 Sep 2021 (actual)
- Primary completion
- 10 Jul 2024 (estimated)
- Study completion
- 10 Aug 2024 (estimated)
- First posted
- 12 May 2022 (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.
A randomized clinical trial is set out to compare the effectiveness of two types of functional appliances in the correction of a Class II malocclusion. (Class II malocclusions are where upper front teeth bite significantly further forward in relation to lower front teeth).
Detailed description
It is a multicenter randomized clinical trial with two arms parallel group. The patients will be randomly divided into two groups, group one: Myobrace appliance will be used while, and group two Twin-block appliances will be used. Cephalometric x-ray will be taken before starting the treatment (T1) and at the end of treatment (T2) at 9 months. The effectiveness of the two appliances will be assessed and measured comparing the difference in the cephalometric X-ray before and after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Myobrace group | Experimental | Device: Myofunctional applianceMyobrace appliance will be used for children who have Cl.II div.a malocclusion |
| Twin-block group | Experimental | Device: Myofunctional applianceTwin-block appliance will be used for children who have Cl.II div.a malocclusion |
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Growing children who need myofunctional appliance.
- Cl II div. 1 malocclusion.
- No previous orthodontic or orthopaedic treatments.
Key exclusion criteria (4 listed)
- Patients with systemic involvement.
- Congenital malformations such as cleft lip and palate.
- Facial deformities.
- Finger sucking habit will be excluded
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 |
|---|---|---|
| Myofunctional applianceMyifunctional appliance will be used for growing patients who have Cl.II div.1 malocclusion, two types of appliances are involved myobrace and twin=block appliance | Device | Myobrace group, Twin-block group |
Primary outcome
Dentoskeletal changes
Time frame: T1 at the start of treatment and T2 at the end of treatment around 9 months
Evaluation of dentoskeletal and soft tissue changes following the treatment of growing children with myobrace and twin block appliances. Using cephalometric analysis to measure the angles including dental angles such as inter-incisal angle, in addition to skeletal angles such as SNA,SNB and ANB angles.
2 secondary outcomes
Soft tissue changes
Time frame: T1 at the start of treatment and T2 at the end of treatment around 9 months
Patient satisfaction
Time frame: At the end of treatment (around 9 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
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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.
Mushriq Abid contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myofunctional appliance in people with Tooth Position Anomalies, run by University of Baghdad at 2 sites in Iraq.
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 3 inclusion and 4 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 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Iraq. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mushriq Abid (7718800706 ext. 00964, mushriq.abid@codental.uobaghdad.edu.iq), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dentoskeletal changes (time frame: T1 at the start of treatment and T2 at the end of treatment around 9 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 28 Nov 2023.