Class III MalocclusionNCT06452368
Palatal Versus Buccal Protraction Using Plates Assisted With Facemask in Growing Class III Patients
A study testing facemask in people with Class III Malocclusion, run by Mansoura University at 1 site in Egypt.
Trial summary
to compare Palatal and buccal protraction using plates assisted with facemask in growing class III patients Read more about this study
- Who is it for?
- Ages 8 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Class III Malocclusion
- What is being tested?
- facemask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2022to 20 Nov 2023
- 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 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Growing patients with age ranged between 8-13 years old.
- Patients should have examination: Class III malocclusion due to maxillary retrusion as verified by clinical and radiographic examination; SNA <79 and ANB angle < -1.
- Good likelihood of recall availability.
Who cannot join
- Vertical skeletal mal relationship.
- History of previous orthodontic/orthopedic treatment.
- Bad habits that may jeopardize the appliance.
- Patients with systemic diseases
- Congenital deformities such as cleft lip and/or palate.
Trial locations and contacts
1 site in 1 country.
About this study
to compare Palatal and buccal protraction using plates assisted with facemask in growing class III patients
Read the detailed description
A randomized controlled clinical trial was adopted in this study. A total of 20 growing Class III patients were selected from patients seeking orthodontic treatment. The participants were recruited from the department of Orthodontics at Faculty of Dentistry, Mansoura University. No active advertisement was used for participant recruitment, and instead, a convenience sample was formed. Prior to participating in the study, the purpose of the study was explained to the parents of the children and informed consents and assents were obtained according to the guidelines on human research adopted by the Research Ethics Committee Faculty of Dentistry, Mansoura University
- Conditions
- Class III Malocclusion
- Being tested
- facemask
- 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.
facemaskDevice
Fixation of miniplates by four screws in the maxilla and protraction by using facemask
| Study group | Role | What they receive |
|---|---|---|
| Palatal protraction | Active comparator | Palatal plate assisted with facemask Receives: Device: facemask |
| Buccal protraction | Active comparator | Buccal plate assisted with facemask Receives: Device: facemask |
What is being measured
The primary outcome is the main question the study is designed to answer.
cephalometric radiographs
cephalometric radiographs were analyzed and the amount of maxillary protraction, the dentoskeletal as well the soft tissue changes were evaluated
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start1 Oct 2022
- Primary completion1 Nov 2023
- Study completion20 Nov 2023
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 Class III MalocclusionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Adel Raghib, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06452368
- Sponsor's protocol ID
- M04020822
- Status last verified
- Jun 2024
- First submitted
- 5 Jun 2024
- Last updated
- 14 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Raghib MA, Elsaharty MA, Mohammad MH, Shamaa M, El-Bialy AA. Palatal versus buccal protraction using plates assisted with facemask in growing Class III patients: A randomized clinical trial. J World Fed Orthod. 2025 Dec;14(6):318-326. doi: 10.1016/j.ejwf.2025.06.004. Epub 2025 Aug 11.
PubMed 40796394
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Palatal Versus Buccal Protraction Using Plates Assisted With Facemask in Growing Class III Patients
- ClinicalTrials.gov ID
- NCT06452368
- Acronym / sponsor ID
- M04020822
- Conditions
- Class III Malocclusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 20 Nov 2023 (actual)
- First posted
- 11 Jun 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.
to compare Palatal and buccal protraction using plates assisted with facemask in growing class III patients
Detailed description
A randomized controlled clinical trial was adopted in this study. A total of 20 growing Class III patients were selected from patients seeking orthodontic treatment. The participants were recruited from the department of Orthodontics at Faculty of Dentistry, Mansoura University. No active advertisement was used for participant recruitment, and instead, a convenience sample was formed. Prior to participating in the study, the purpose of the study was explained to the parents of the children and informed consents and assents were obtained according to the guidelines on human research adopted by the Research Ethics Committee Faculty of Dentistry, Mansoura University
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Palatal protraction | Active comparator | Device: facemaskPalatal plate assisted with facemask |
| Buccal protraction | Active comparator | Device: facemaskBuccal plate assisted with facemask |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Growing patients with age ranged between 8-13 years old.
- Patients should have examination: Class III malocclusion due to maxillary retrusion as verified by clinical and radiographic examination; SNA <79 and ANB angle < -1.
- Good likelihood of recall availability.
Key exclusion criteria (5 listed)
- Vertical skeletal mal relationship.
- History of previous orthodontic/orthopedic treatment.
- Bad habits that may jeopardize the appliance.
- Patients with systemic diseases
- Congenital deformities such as cleft lip and/or palate.
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 |
|---|---|---|
| facemaskFixation of miniplates by four screws in the maxilla and protraction by using facemask | Device | Buccal protraction, Palatal protraction |
Primary outcome
cephalometric radiographs
Time frame: 12 month
cephalometric radiographs were analyzed and the amount of maxillary protraction, the dentoskeletal as well the soft tissue changes were evaluated
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 14 Jun 2024.
- Derived from this study: PubMed 40796394Raghib MA, Elsaharty MA, Mohammad MH, Shamaa M, El-Bialy AA. Palatal versus buccal protraction using plates assisted with facemask in growing Class III patients: A randomized clinical trial. J World Fed Orthod. 2025 Dec;14(6):318-326. doi: 10.1016/j.ejwf.2025.06.004. Epub 2025 Aug 11.
- 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 facemask in people with Class III Malocclusion, run by Mansoura University at 1 site in Egypt.
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 5 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 14 Jun 2024. 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 Egypt. 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?
cephalometric radiographs (time frame: 12 month). 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 NCT06452368, 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 14 Jun 2024.