- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05433051
A Comparison of Two Protocol for Maxillary Molar Intrusion Buccal Miniscrew and TPA Versus Vertical Holding Appliance
May 21, 2024 updated by: Mohamed Abdelrhman Shendy Abdelrhman, Al-Azhar University
A Comparison of Two Protocol for Maxillary Molar Intrusion Buccal Miniscrew and TPA Versus Vertical Holding Appliance Randomized Controlled Trial
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Nasr City
-
Cairo, Nasr City, Egypt, 002
- Mohamed Shendy
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 20 years (Child, Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Buccal miniscrews with TPA
active comparator double center
|
intrusion of molars
|
|
Active Comparator: vertical holding appliance
active comparator double center
|
intrusion of molars
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
amount of dental
Time Frame: Post-intervention at 6 months
|
rate of maxillary molar intrusion by cephalometry
|
Post-intervention at 6 months
|
|
amount of skeletal changes
Time Frame: Post-intervention at 6 months
|
amount of vertical overlap by cephalometry
|
Post-intervention at 6 months
|
|
amount of skeletal changes
Time Frame: Post-intervention at 6 months
|
amount of mandibular rotation by cephalometry
|
Post-intervention at 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 10, 2022
Primary Completion (Estimated)
October 10, 2024
Study Completion (Estimated)
October 30, 2024
Study Registration Dates
First Submitted
June 22, 2022
First Submitted That Met QC Criteria
June 22, 2022
First Posted (Actual)
June 27, 2022
Study Record Updates
Last Update Posted (Actual)
May 22, 2024
Last Update Submitted That Met QC Criteria
May 21, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 807/220
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.