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CompletedNCT06452368Updated Jun 14, 2024

Palatal Versus Buccal Protraction Using Plates Assisted With Facemask in Growing Class III Patients

An interventional study of facemask in Class III Malocclusion, sponsored by Mansoura University. Completed at 1 site in Egypt. Open to participants aged 8 Years to 13 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-14.

Sponsored by Mansoura University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 8 months after the study started (first participant enrolled Oct 2022, registered Jun 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
8 Years to 13 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Class III Malocclusion
03

In context

Malocclusion, Angle Class III

57 studies on the registry are indexed under Malocclusion, Angle Class III; 11 are open to participants now.

This study's enrollment of 20 is below the median of 32 across 53 interventional studies indexed under Malocclusion, Angle Class III.

Browse Malocclusion, Angle Class III studies →

Lead sponsor

Mansoura University is the lead sponsor of 1,119 studies on the registry; 183 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years to 13 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Active comparator
    Palatal protraction

    Palatal plate assisted with facemask

    Device: facemask

  • Active comparator
    Buccal protraction

    Buccal plate assisted with facemask

    Device: facemask

Interventions

  • Devicefacemask

    Fixation of miniplates by four screws in the maxilla and protraction by using facemask

06

What researchers measure

Primary outcomes

  1. cephalometric radiographs

    cephalometric radiographs were analyzed and the amount of maxillary protraction, the dentoskeletal as well the soft tissue changes were evaluated

    Time frame: 12 month

07

Study locations

1 site
  • Mohamed Adel Raghib
    Mansoura, Dakahlia 35516, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2022 to primary completion in Nov 2023, 13 months.

Of 37 non-industry interventional studies with no phase under Malocclusion, Angle Class III, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 26. This study's 13 months is close to that.

Counting every sponsor, half of 38 studies reached it within 13 months; a quarter within 10 and three quarters within 26.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 5, 2024
First posted
Jun 11, 2024
StartActual
Oct 1, 2022
Primary completionActual
Nov 1, 2023
CompletionActual
Nov 20, 2023
Last update
Jun 14, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 14, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06452368
Responsible party
Mohamed Adel Raghib (Phd researcher, Mansoura University) — Principal investigator
First posted
Jun 11, 2024
Start date
Oct 1, 2022
Primary completion
Nov 1, 2023
Completion
Nov 20, 2023
Last update
Jun 14, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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