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

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

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)

Study Overview

• Status: Unknown
• Conditions: Class II Division 1 Malocclusion
• Intervention / Treatment: Device: Infra-zygomatic Mini Implant Supported Appliance; Device: high pull head gear

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 Type: Interventional
• Enrollment (Anticipated): 26
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed Afifi; Phone Number: +201007025732; Email: Ahmed.Khaled@dentistry.cu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Cairo University
    • Contact: Cairo university; Phone Number: 522 0223642705

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 15 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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
Active Comparator: Headgear; 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	Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anteroposterior position changes of upper first molars.	Measurements on the lateral cephalogram	8 months
Anteroposterior position changes of the maxilla	Measurements on the lateral cephalogram	8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vertical position changes in maxilla	Measurements on the lateral cephalogram	8 months
Vertical position changes of upper first molars	Measurements on the lateral cephalogram	8 months
Position changes of upper incisors	Measurements on the lateral cephalogram	8 months
Anteroposterior skeletal changes in mandible	Measurements on the lateral cephalogram	8 months

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Ahmed Afifi, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Anticipated): November 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: February 11, 2019
• First Submitted That Met QC Criteria: February 12, 2019
• First Posted (Actual): February 15, 2019

Study Record Updates

• Last Update Posted (Actual): May 21, 2019
• Last Update Submitted That Met QC Criteria: May 18, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion
• Other Study ID Numbers: 18-11-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No