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

NCT03839303 | Unknown DMC

• 1 other identifier: 18-11-1
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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)

Conditions

Class II Division 1 Malocclusion

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Vertical position changes in maxilla

  8 months

• Vertical position changes of upper first molars

  8 months

• Position changes of upper incisors

  8 months

• Anteroposterior skeletal changes in mandible

  8 months

Study Arms (2)

Mini Implant Supported Appliance

EXPERIMENTAL

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

Headgear

ACTIVE COMPARATOR

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

Interventions

Infra-zygomatic Mini Implant Supported Appliance 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

Mini Implant Supported Appliance

high pull head gear DEVICE

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

Headgear

Eligibility Criteria

• Age: 7 Years - 15 Years
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Growing patients ( cervical vertebrae maturation stage cs2-cs3 )
• Maxillary excess
• Minimum overjet 4 mm
• class II canines or incisors
• Increased incisal show at rest and on smiling
• Normal and increased vertical growth pattern
• No previous orthodontic treatment
• No congenitally messing teeth except third molars

You may not qualify if:

• Inadequate incisal show
• Class II with deficient mandible and normal maxilla
• Patients with any syndrome
• Patients with horizontal growth pattern

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Malocclusion, Angle Class II

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Ahmed Afifi

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Afifi

CONTACT

+201007025732; Ahmed.Khaled@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident in orthodontic department of Cairo University

Study Record Dates

• First Submitted: February 11, 2019
• First Posted: February 15, 2019
• Study Start: March 1, 2019
• Primary Completion: November 1, 2019
• Study Completion: December 1, 2019
• Last Updated: May 21, 2019

Record last verified: 2019-05

Locations

EG (1)