NCT06209125

Brief Summary

use new hybrid aesthetic functional appliance for treatment of class II div 1 malocclusion.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 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

February 1, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 8, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 7, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 17, 2024

Completed
Last Updated

January 22, 2024

Status Verified

January 1, 2024

Enrollment Period

1.1 years

First QC Date

January 7, 2024

Last Update Submit

January 19, 2024

Conditions

Class II Malocclusion

Outcome Measures

Primary Outcomes (1)

  • Early correction of skeletal classII division I by the hybrid aesthetic functional appliances (HAF)

    early treatment of class II division 1 malocclusion using HAF appliance and evaluate the skeletal and dental effect of new appliance by take cephalogram before and after treatments

    one year

Study Arms (1)

study group

OTHER

use new device for treatment of class II malocclusion

Device: hybrid aesthetic functional appliance

Interventions

hybrid aesthetic functional applianceDEVICE

treatment of class II division one malocclusion

study group

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Age included is the mixed dentition stage ( 6 -12 y )
  • skeletal Class II division 1.
  • Overjet more than 4 mm.

You may not qualify if:

  • Previous orthodontic treatment.
  • Bad oral hygiene.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University

Al Mansurah, 35516, Egypt

Location

MeSH Terms

Conditions

Overbite

Condition Hierarchy (Ancestors)

Malocclusion, Angle Class IIMalocclusionTooth DiseasesStomatognathic Diseases

Study Officials

  • sohaila ad ahmed, master

    Mansoura University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 7, 2024

First Posted

January 17, 2024

Study Start

February 1, 2022

Primary Completion

March 2, 2023

Study Completion

May 8, 2023

Last Updated

January 22, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)