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

NCT ID: NCT03839303

Last Updated: 2019-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2019-12-01

Brief Summary

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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

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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

Conditions

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Class II Division 1 Malocclusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Infra-zygomatic Mini Implant Supported Appliance

Intervention Type DEVICE

1. leveling and alignment of the four maxillary incisors
2. infra zygomatic mini-implant will be placed bilaterally
3. wire frame work that is designed resembling the inner bow of headgear will be adapted to the upper arch
4. a heavy arch wire engaging the 4 incisors will be attached to the wire frame work
5. orthopedic force will be delivered from the mini-implants to the wire frame work

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

Group Type ACTIVE_COMPARATOR

high pull head gear

Intervention Type DEVICE

1. acrylic maxillary splint is made with flying tubes
2. high pull head gear is adapted to be inserted in the flying tubes

Interventions

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Infra-zygomatic Mini Implant Supported Appliance

1. leveling and alignment of the four maxillary incisors
2. infra zygomatic mini-implant will be placed bilaterally
3. wire frame work that is designed resembling the inner bow of headgear will be adapted to the upper arch
4. a heavy arch wire engaging the 4 incisors will be attached to the wire frame work
5. orthopedic force will be delivered from the mini-implants to the wire frame work

Intervention Type DEVICE

high pull head gear

1. acrylic maxillary splint is made with flying tubes
2. high pull head gear is adapted to be inserted in the flying tubes

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

7 Years

Maximum Eligible Age

15 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Khaled Mohamed Mohamed

Resident in orthodontic department of Cairo University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed Afifi

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

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Cairo University

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Ahmed Afifi

Role: CONTACT

+201007025732

Facility Contacts

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Cairo university

Role: primary

0223642705 ext. 522

Other Identifiers

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18-11-1

Identifier Type: -

Identifier Source: org_study_id

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