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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03839303
Other study ID # 18-11-1
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 1, 2019
Est. completion date December 1, 2019

Study information

Verified date May 2019
Source Cairo University
Contact Ahmed Afifi
Phone +201007025732
Email Ahmed.Khaled@dentistry.cu.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of the study is to compare an Infra-zygomatic Mini implant supported appliance with headgear in distalization and intrusion of maxillary dentition for treatment of growing patients with class II malocclusion (maxillary excess)


Description:

In this randomized trial, 2 groups will be included. The first group will receive an Infra-zygomatic Mini implant supported appliance. In the second group, the patient will receive a removable high pull headgear. the follow-up period will be 8 months or till class I canine or incisors relation is obtained. the assessment will be through a lateral cephalogram


Recruitment information / eligibility

Status Recruiting
Enrollment 26
Est. completion date December 1, 2019
Est. primary completion date November 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 7 Years to 15 Years
Eligibility Inclusion Criteria:

1. Growing patients ( cervical vertebrae maturation stage cs2-cs3 )

2. Maxillary excess

3. Minimum overjet 4 mm

4. class II canines or incisors

5. Increased incisal show at rest and on smiling

6. Normal and increased vertical growth pattern

7. No previous orthodontic treatment

8. No congenitally messing teeth except third molars

Exclusion Criteria:

1. Inadequate incisal show

2. Class II with deficient mandible and normal maxilla

3. Patients with any syndrome

4. Patients with horizontal growth pattern

Study Design


Intervention

Device:
Infra-zygomatic Mini Implant Supported Appliance
leveling and alignment of the four maxillary incisors infra zygomatic mini-implant will be placed bilaterally wire frame work that is designed resembling the inner bow of headgear will be adapted to the upper arch a heavy arch wire engaging the 4 incisors will be attached to the wire frame work orthopedic force will be delivered from the mini-implants to the wire frame work
high pull head gear
acrylic maxillary splint is made with flying tubes high pull head gear is adapted to be inserted in the flying tubes

Locations

Country Name City State
Egypt Cairo University Cairo

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Anteroposterior position changes of upper first molars. Measurements on the lateral cephalogram 8 months
Primary Anteroposterior position changes of the maxilla Measurements on the lateral cephalogram 8 months
Secondary Vertical position changes in maxilla Measurements on the lateral cephalogram 8 months
Secondary Vertical position changes of upper first molars Measurements on the lateral cephalogram 8 months
Secondary Position changes of upper incisors Measurements on the lateral cephalogram 8 months
Secondary Anteroposterior skeletal changes in mandible Measurements on the lateral cephalogram 8 months
See also
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