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

Not Applicable

• Conditions: Class II Division 1 Malocclusion
• Interventions: Device: Infra-zygomatic Mini Implant Supported Appliance; Device: high pull head gear

• Registration Number: NCT03839303
• Lead Sponsor: Cairo University

Brief 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)

Detailed 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

Study Timeline

• Study First Submitted: 2019-02-11
• Study First Submitted QC: 2019-02-12
• Study First Posted: 2019-02-15
• Study Start: 2019-03-01
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-18
• Last Update Posted: 2019-05-21
• Primary Completion: 2019-11-01
• Study Completion: 2019-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 26

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mini Implant Supported Appliance	Infra-zygomatic Mini Implant Supported Appliance	this group will receive an Infra-zygomatic Mini Implant Supported Appliance after leveling and alignment of the four upper incisors for 8 months or till class I canine or incisors realation is reached with follow up every month
Headgear	high pull head gear	this group will receive a high pull headgear appliance attached to a removable acrylic maxillary splint for 8 months or till class I canine or incisors realation is reached with follow up every month

Primary Outcome Measures

Name	Time	Method
Anteroposterior position changes of the maxilla	8 months	Measurements on the lateral cephalogram
Anteroposterior position changes of upper first molars.	8 months	Measurements on the lateral cephalogram

Secondary Outcome Measures

Name	Time	Method
Vertical position changes of upper first molars	8 months	Measurements on the lateral cephalogram
Vertical position changes in maxilla	8 months	Measurements on the lateral cephalogram
Position changes of upper incisors	8 months	Measurements on the lateral cephalogram
Anteroposterior skeletal changes in mandible	8 months	Measurements on the lateral cephalogram

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt