Back to resultsComparison Between Mini Implant Supported Appliance and Headgear in Treatment of Maxillary Excess in Growing Patients
Primary Purpose
Class II Division 1 Malocclusion
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Infra-zygomatic Mini Implant Supported Appliance
high pull head gear
Sponsored by
About this trial
This is an interventional treatment trial for Class II Division 1 Malocclusion
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Inadequate incisal show
- Class II with deficient mandible and normal maxilla
- Patients with any syndrome
- Patients with horizontal growth pattern
Sites / Locations
- Cairo UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Mini Implant Supported Appliance
Headgear
Arm Description
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
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
Outcomes
Primary Outcome Measures
Anteroposterior position changes of upper first molars.
Measurements on the lateral cephalogram
Anteroposterior position changes of the maxilla
Measurements on the lateral cephalogram
Secondary Outcome Measures
Vertical position changes in maxilla
Measurements on the lateral cephalogram
Vertical position changes of upper first molars
Measurements on the lateral cephalogram
Position changes of upper incisors
Measurements on the lateral cephalogram
Anteroposterior skeletal changes in mandible
Measurements on the lateral cephalogram
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03839303
Brief Title
Comparison Between Mini Implant Supported Appliance and Headgear in Treatment of Maxillary Excess in Growing Patients
Official Title
Infra-zygomatic Mini Implant Supported Appliance for Distalization and Intrusion of Maxillary Dentition Compared to Headgear in Growing Patients: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
November 1, 2019 (Anticipated)
Study Completion Date
December 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Class II Division 1 Malocclusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
26 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mini Implant Supported Appliance
Arm Type
Experimental
Arm Description
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
Arm Title
Headgear
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Infra-zygomatic Mini Implant Supported Appliance
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
high pull head gear
Intervention Description
acrylic maxillary splint is made with flying tubes
high pull head gear is adapted to be inserted in the flying tubes
Primary Outcome Measure Information:
Title
Anteroposterior position changes of upper first molars.
Description
Measurements on the lateral cephalogram
Time Frame
8 months
Title
Anteroposterior position changes of the maxilla
Description
Measurements on the lateral cephalogram
Time Frame
8 months
Secondary Outcome Measure Information:
Title
Vertical position changes in maxilla
Description
Measurements on the lateral cephalogram
Time Frame
8 months
Title
Vertical position changes of upper first molars
Description
Measurements on the lateral cephalogram
Time Frame
8 months
Title
Position changes of upper incisors
Description
Measurements on the lateral cephalogram
Time Frame
8 months
Title
Anteroposterior skeletal changes in mandible
Description
Measurements on the lateral cephalogram
Time Frame
8 months
10. Eligibility
Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Inadequate incisal show
Class II with deficient mandible and normal maxilla
Patients with any syndrome
Patients with horizontal growth pattern
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Afifi
Phone
+201007025732
Email
Ahmed.Khaled@dentistry.cu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Afifi
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cairo University
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cairo university
Phone
0223642705
Ext
522
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Comparison Between Mini Implant Supported Appliance and Headgear in Treatment of Maxillary Excess in Growing Patients
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