Jaw ProtrusionsNCT06250127
The Effectiveness of Modified 3D Printed Customized Facemask Appliance for Treatment of Class III Malocclusion
A study testing Modified 3D printed facemask and Conventional facemask appliance in people with Jaw Protrusions, run by University of Baghdad at 2 sites in Iraq.
Trial summary
A randomized clinical trial to introduce a modified 3D printed customized maxillary protraction facemask and evaluate its efficacy in comparison with the conventional maxillary protraction facemask therapy in correction of Class III malocclusion of young patients Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Jaw Protrusions
- What is being tested?
- Modified 3D printed facemask and Conventional facemask appliance
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 2 sitesIraq
- Study dates
- 1 Dec 2022to 1 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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Skeletal and dental relationships: skeletal class III with retrognathic maxilla and normal mandible with overjet < 0 mm.
- Concave profile with normal lower facial height (clinically and radiographically).
- Good oral health free from caries and periodontal problems at the start of treatment.
Who cannot join
- Previous history of orthopedic and/or orthodontic treatment.
- Patients with vertical growth pattern or backward mandibular rotation tendency.
- Patients with gross facial asymmetry.
- Patients with cleft lip and palate and/or craniofacial syndrome
- Patients with bad oral habit.
- Active periodontal disease.
- Previous history of TMJ signs or symptoms
Trial locations and contacts
2 sites in 1 country.
Iraq2 sites, 2 recruiting
- Recruiting
College of Dentistry-University of Baghdad
Baghdad, Al-Rusafa, 01110
Mushriq Abid, 414169375 ext. 00964, mushriq.abid@codental.uobaghdad.edu.iq
- Recruiting
Mushriq Abid
Baghdad, 01110
Mushriq Abid, 414169375 ext. 00964, mushriq.abid@codental.uobaghdad.edu.iq
About this study
Official title: The Effectiveness of Modified 3D Printed Customized Facemask Appliance for Treatment of Class III Malocclusion: A Randomized Clinical Trial
A randomized clinical trial to introduce a modified 3D printed customized maxillary protraction facemask and evaluate its efficacy in comparison with the conventional maxillary protraction facemask therapy in correction of Class III malocclusion of young patients
Read the detailed description
It is a multicenter randomized clinical trial with two parallel arms. The patients will be randomly divided into two groups, group one: conventional facemask appliance will be used while group two, the modified facemask appliances. Lateral cephalometric x-ray, Study models, photographs, and patient questionnaire will be taken before starting the treatment (T0) and at the end of treatment (T1). The effectiveness of the two appliances will be assessed and measured comparing patient's records before and after treatment.
- Conditions
- Jaw Protrusions
- Being tested
- Modified 3D printed facemask, Conventional facemask appliance
- Keywords
- Orthopedic appliance, Maxillary protraction, Petit facemask, Cl III malocclusion
- Medical subject headings
- Malocclusion, Angle Class III
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified 3D printed facemaskDevice
modified 3D printed customized maxillary protraction facemask will be used for growing patients who have Cl. III malocclusion, hyrax expansion appliance and applying an elastic force of 300-500 gram per side for 12-14 hours per day. Treatment time 9 months.
Conventional facemask applianceDevice
Conventional facemask appliance will be used for growing patients who have Cl. III malocclusion, hyrax expansion appliance and applying an elastic force of 300-500 gram per side for 12-14 hours per day. Treatment time 9 months.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Conventional facemask) | Active comparator | Conventional facemask appliance will be used for growing patients who have Cl. III malocclusion. Receives: Device: Conventional facemask appliance |
| Group 2 (Modified 3D printed facemask) | Experimental | Modified facemask appliances will be used for growing patients who have Cl. III malocclusion. Receives: Device: Modified 3D printed facemask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dentoskeletal and soft tissue changes
Cephalometric analysis will be perfomed by measured different skeletal and soft tissue points in degrees at two time (T) intervals, (T0) before starting the treatment and (T1) at 9 months after treatment.
Measured: (T0) before starting the treatment and (T1) after 9 months of treatments.
Secondary outcomes (2)
Skeletal and soft tissue changes
Skeletal changes by comparing the changes of SNA, SNB and ANB angles in degrees using cephalometric x-rays at two time intervals, (T0) before starting the treatment and (T1) after 9 months of treatments.
Measured: (T0) before starting the treatment and (T1) after 9 months of treatments.
Dental changes
Dental changes will be evalauted by comparing over jet changes in millimeters assessed using study models.at two time intervals, (T0) before starting the treatment and (T1) after 9 months of treatments.
Measured: (T0) before starting any treatment and (T1) after 9 months of treatments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start1 Dec 2022
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Jaw ProtrusionsStudies 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
- 34 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
- NCT06250127
- Sponsor's protocol ID
- 882423
- Status last verified
- Feb 2024
- First submitted
- 21 Jan 2024
- Last updated
- 12 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Abdulkareem GB, Cobourne MT, Abid M. The effectiveness of novel 3D printed customized facemask appliance for treatment of class III malocclusion: a randomized clinical trial. Eur J Orthod. 2025 Oct 16;47(6):cjaf075. doi: 10.1093/ejo/cjaf075.
PubMed 41121454
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Modified 3D Printed Customized Facemask Appliance for Treatment of Class III Malocclusion: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06250127
- Acronym / sponsor ID
- 882423
- Conditions
- Jaw Protrusions
- Keywords
- Orthopedic appliance, Maxillary protraction, Petit facemask, Cl III malocclusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 8 Feb 2024 (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 to introduce a modified 3D printed customized maxillary protraction facemask and evaluate its efficacy in comparison with the conventional maxillary protraction facemask therapy in correction of Class III malocclusion of young patients
Detailed description
It is a multicenter randomized clinical trial with two parallel arms. The patients will be randomly divided into two groups, group one: conventional facemask appliance will be used while group two, the modified facemask appliances. Lateral cephalometric x-ray, Study models, photographs, and patient questionnaire will be taken before starting the treatment (T0) and at the end of treatment (T1). The effectiveness of the two appliances will be assessed and measured comparing patient's records 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 |
|---|---|---|
| Group 1 (Conventional facemask) | Active comparator | Device: Conventional facemask applianceConventional facemask appliance will be used for growing patients who have Cl. III malocclusion. |
| Group 2 (Modified 3D printed facemask) | Experimental | Device: Modified 3D printed facemaskModified facemask appliances will be used for growing patients who have Cl. III malocclusion. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Skeletal and dental relationships: skeletal class III with retrognathic maxilla and normal mandible with overjet < 0 mm.
- Concave profile with normal lower facial height (clinically and radiographically).
- Good oral health free from caries and periodontal problems at the start of treatment.
Key exclusion criteria (7 listed)
- Previous history of orthopedic and/or orthodontic treatment.
- Patients with vertical growth pattern or backward mandibular rotation tendency.
- Patients with gross facial asymmetry.
- Patients with cleft lip and palate and/or craniofacial syndrome
- Patients with bad oral habit.
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 |
|---|---|---|
| Modified 3D printed facemaskmodified 3D printed customized maxillary protraction facemask will be used for growing patients who have Cl. III malocclusion, hyrax expansion appliance and applying an elastic force of 300-500 gram per side for 12-14 hours per day. Treatment time 9 months. | Device | Group 2 (Modified 3D printed facemask) |
| Conventional facemask applianceConventional facemask appliance will be used for growing patients who have Cl. III malocclusion, hyrax expansion appliance and applying an elastic force of 300-500 gram per side for 12-14 hours per day. Treatment time 9 months. | Device | Group 1 (Conventional facemask) |
Primary outcome
Dentoskeletal and soft tissue changes
Time frame: (T0) before starting the treatment and (T1) after 9 months of treatments.
Cephalometric analysis will be perfomed by measured different skeletal and soft tissue points in degrees at two time (T) intervals, (T0) before starting the treatment and (T1) at 9 months after treatment.
2 secondary outcomes
Skeletal and soft tissue changes
Time frame: (T0) before starting the treatment and (T1) after 9 months of treatments.
Dental changes
Time frame: (T0) before starting any treatment and (T1) after 9 months of treatments
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2024.
- Derived from this study: PubMed 41121454Abdulkareem GB, Cobourne MT, Abid M. The effectiveness of novel 3D printed customized facemask appliance for treatment of class III malocclusion: a randomized clinical trial. Eur J Orthod. 2025 Oct 16;47(6):cjaf075. doi: 10.1093/ejo/cjaf075.
- Individual participant dataSharing planned: Undecided
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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.
College of Dentistry-University of Baghdad
Baghdad, Iraq
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified 3D printed facemask and Conventional facemask appliance in people with Jaw Protrusions, 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 7 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 12 Feb 2024. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dentoskeletal and soft tissue changes (time frame: (T0) before starting the treatment and (T1) after 9 months of treatments.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06250127, which also lists 1 linked publication.
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 12 Feb 2024.