Back to resultsA Comparison of Two Protocol for Maxillary Molar Intrusion Buccal Miniscrew and TPA Versus Vertical Holding Appliance
Primary Purpose
Dental Intrusion, Mandibular Rotation, ANB , SNA, SNB
Status
Active
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
buccal miniscrew and TPA
vertical holding appliance
Sponsored by
About this trial
This is an interventional basic science trial for Dental Intrusion focused on measuring TPA, Miniscrew, intrusion, vertical holding appliance, cephalometry
Eligibility Criteria
Inclusion Criteria:
- Patients suffering class I or II with AOB.
- AOB ranged between 3-7 mm assessed from cephalometry.
- Patients with excess in posterior dentoalveolar height according to Burrstone .
- Patients with good oral hygiene and general health.
- Patients with no previous orthodontic treatment.
- Good quality of lateral cephalometry.
Exclusion Criteria:
- Skeletal open bite
- previous orthodontic treatment
Sites / Locations
- Mohamed Shendy
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Buccal miniscrews with TPA
vertical holding appliance
Arm Description
active comparator double center
active comparator double center
Outcomes
Primary Outcome Measures
amount of dental
rate of maxillary molar intrusion by cephalometry
amount of skeletal changes
amount of vertical overlap by cephalometry
amount of skeletal changes
amount of mandibular rotation by cephalometry
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05433051
Brief Title
A Comparison of Two Protocol for Maxillary Molar Intrusion Buccal Miniscrew and TPA Versus Vertical Holding Appliance
Official Title
A Comparison of Two Protocol for Maxillary Molar Intrusion Buccal Miniscrew and TPA Versus Vertical Holding Appliance Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 10, 2022 (Actual)
Primary Completion Date
October 10, 2023 (Anticipated)
Study Completion Date
October 30, 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
Data Monitoring Committee
No
5. Study Description
Brief Summary
this study is to compare the dental and skeletal changes caused by the intrusion of maxillary first molars buccal miniscrew and TPA versus vertical holding appliance using lateral cephalometry.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Intrusion, Mandibular Rotation, ANB , SNA, SNB, Openbite Teeth | Teeth and Gum | Dental
Keywords
TPA, Miniscrew, intrusion, vertical holding appliance, cephalometry
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Buccal miniscrews with TPA
Arm Type
Active Comparator
Arm Description
active comparator double center
Arm Title
vertical holding appliance
Arm Type
Active Comparator
Arm Description
active comparator double center
Intervention Type
Biological
Intervention Name(s)
buccal miniscrew and TPA
Intervention Description
intrusion of molars
Intervention Type
Biological
Intervention Name(s)
vertical holding appliance
Intervention Description
intrusion of molars
Primary Outcome Measure Information:
Title
amount of dental
Description
rate of maxillary molar intrusion by cephalometry
Time Frame
Post-intervention at 6 months
Title
amount of skeletal changes
Description
amount of vertical overlap by cephalometry
Time Frame
Post-intervention at 6 months
Title
amount of skeletal changes
Description
amount of mandibular rotation by cephalometry
Time Frame
Post-intervention at 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients suffering class I or II with AOB.
AOB ranged between 3-7 mm assessed from cephalometry.
Patients with excess in posterior dentoalveolar height according to Burrstone .
Patients with good oral hygiene and general health.
Patients with no previous orthodontic treatment.
Good quality of lateral cephalometry.
Exclusion Criteria:
Skeletal open bite
previous orthodontic treatment
Facility Information:
Facility Name
Mohamed Shendy
City
Cairo
State/Province
Nasr City
ZIP/Postal Code
002
Country
Egypt
12. IPD Sharing Statement
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A Comparison of Two Protocol for Maxillary Molar Intrusion Buccal Miniscrew and TPA Versus Vertical Holding Appliance
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