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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03839303
Enrollment
26
Registered
2019-02-15
Start date
2019-03-01
Completion date
2019-12-01
Last updated
2019-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Class II Division 1 Malocclusion

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

Interventions

DEVICEInfra-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

DEVICEhigh 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

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
7 Years to 15 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Anteroposterior position changes of upper first molars.8 monthsMeasurements on the lateral cephalogram
Anteroposterior position changes of the maxilla8 monthsMeasurements on the lateral cephalogram

Secondary

MeasureTime frameDescription
Vertical position changes in maxilla8 monthsMeasurements on the lateral cephalogram
Vertical position changes of upper first molars8 monthsMeasurements on the lateral cephalogram
Position changes of upper incisors8 monthsMeasurements on the lateral cephalogram
Anteroposterior skeletal changes in mandible8 monthsMeasurements on the lateral cephalogram

Countries

Egypt

Contacts

Primary ContactAhmed Afifi
Ahmed.Khaled@dentistry.cu.edu.eg+201007025732

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026