NCT06452368

Brief Summary

to compare Palatal and buccal protraction using plates assisted with facemask in growing class III patients

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 5, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 11, 2024

Completed
Last Updated

June 14, 2024

Status Verified

June 1, 2024

Enrollment Period

1.1 years

First QC Date

June 5, 2024

Last Update Submit

June 12, 2024

Conditions

Class III Malocclusion

Outcome Measures

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

    12 month

Study Arms (2)

Palatal protraction

ACTIVE COMPARATOR

Palatal plate assisted with facemask

Device: facemask

Buccal protraction

ACTIVE COMPARATOR

Buccal plate assisted with facemask

Device: facemask

Interventions

facemaskDEVICE

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

Buccal protractionPalatal protraction

Eligibility Criteria

Age8 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mohamed Adel Raghib

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location

MeSH Terms

Conditions

Malocclusion, Angle Class III

Condition Hierarchy (Ancestors)

MalocclusionTooth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Phd researcher

Study Record Dates

First Submitted

June 5, 2024

First Posted

June 11, 2024

Study Start

October 1, 2022

Primary Completion

November 1, 2023

Study Completion

November 20, 2023

Last Updated

June 14, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)