Back to resultsTow Maxillary Hybrid Expanders Screw Supported Versus Lateral Angulated One; a Prospective Randomized Clinical Study
Primary Purpose
Cross Bite
Status
Active
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
hybrid expanders
Sponsored by
About this trial
This is an interventional treatment trial for Cross Bite
Eligibility Criteria
Inclusion Criteria:
- Medically free male or female patients
- Patients that necessitated maxillary expansion due to constricted maxillary arch shown by a unilateral or bilateral posterior crossbite.
- The patient should have no missing teeth except third molars.
- Age ranged from 12 to 18 years old.
- The patient should have a good gingival condition.
- The patient should have a good periodontal condition.
Exclusion Criteria:
1-hisory of previous orthodontic treatment. 2- Lack of cooperation. 3- Mental problems. 4- Skeletal open bite. 5- TMJ problem.
-
Sites / Locations
- Al azhar university
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
group (1)
group (2)
Arm Description
tow perpendicular miniscrews supported hybrid expanders
tow angulated miniscrews supported hybrid expanders
Outcomes
Primary Outcome Measures
change in maxillary width
millimeter
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05193513
Brief Title
Tow Maxillary Hybrid Expanders Screw Supported Versus Lateral Angulated One; a Prospective Randomized Clinical Study
Official Title
Comparison of Tow Maxillary Hybrid Expanders -Perpendicular Screw Supported Versus Lateral Angulated One; a Prospective Randomized Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 10, 2021 (Actual)
Primary Completion Date
June 10, 2023 (Anticipated)
Study Completion Date
October 14, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
in this study i will use to different designs of t maxillary hybrid expanders that consists of HYREX supported with tow miniscrews to treat the collapsed maxilla in Yonge adolescents
Detailed Description
the maxilla is expanded by tow diffrent designs of maxillary hybrid expanders
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cross Bite
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
group (1)
Arm Type
Experimental
Arm Description
tow perpendicular miniscrews supported hybrid expanders
Arm Title
group (2)
Arm Type
Experimental
Arm Description
tow angulated miniscrews supported hybrid expanders
Intervention Type
Device
Intervention Name(s)
hybrid expanders
Intervention Description
tow maxillary hybrid expanders supported anteriorly with tow miniscrews
Primary Outcome Measure Information:
Title
change in maxillary width
Description
millimeter
Time Frame
12 weeks following end of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Medically free male or female patients
Patients that necessitated maxillary expansion due to constricted maxillary arch shown by a unilateral or bilateral posterior crossbite.
The patient should have no missing teeth except third molars.
Age ranged from 12 to 18 years old.
The patient should have a good gingival condition.
The patient should have a good periodontal condition.
Exclusion Criteria:
1-hisory of previous orthodontic treatment. 2- Lack of cooperation. 3- Mental problems. 4- Skeletal open bite. 5- TMJ problem.
-
Facility Information:
Facility Name
Al azhar university
City
Cairo
ZIP/Postal Code
11311
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Tow Maxillary Hybrid Expanders Screw Supported Versus Lateral Angulated One; a Prospective Randomized Clinical Study
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