Comparison Between Mini Implant Supported Appliance and Headgear in Treatment of Maxillary Excess in Growing Patients

Class II Division 1 Malocclusion Clinical Trial

Official title:

Infra-zygomatic Mini Implant Supported Appliance for Distalization and Intrusion of Maxillary Dentition Compared to Headgear in Growing Patients: A Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03839303
• Other study ID #: 18-11-1
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Class II Division 1 Malocclusion
• Malocclusion
• Malocclusion, Angle Class II

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