- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06677619
Assessment of Changes in Labioincisal Relationship in Deep Bite Correction by Twin Slot Orthodontic Bracket Clinical Trial Study.
November 5, 2024 updated by: Hend mohamed Abdelhalem Hegazy, Faculty of Dental Medicine for Girls
Assessment Changes in Labio incisal Relationship in Deep bite Correction by Twin Slot Orthodontic Bracket; clinical trial study.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Group(A): patients will be treated with double slot bracket with wire in incisal slot Group(B):patients will be treated with double slot bracket with wire in cervical slot
Study Type
Interventional
Enrollment (Actual)
16
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
-
-
-
Cairo, Egypt, 002
- Hend Hegazy
-
-
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
- Child
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
• Mild to moderate deep bite.
- Permanent dentition stage (excluding the third molar)
- Age ranges from 16-23 years.
- Free from any medical or systemic condition that could interfere with
- Orthodontic treatment plane or effect on procedures. Angle class1 or class11 malocclusion with minimal crowding.
- Female patient to avoide any sexual dimorphism which may affect the comparison.
- Good oral hygiene.
- No previous orthodontic treatment.
Exclusion Criteria:
Uncooperative patient.
- Frequent missing appointments.
- Frequent broken appliance.
- Previous orthodontic treatments.
- Any systemic or bone diseases.
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: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: intrusion by reverse curve in cervical position
double slot bracket with reverse curvein cervical slot
|
intrusion of anterior teeth by putting reverse curve wire in incisal slot of twin slot bracket
|
|
Experimental: intrusion with reverse curve in incisal position
double slot bracket reverse curvein incisal slot
|
intrusion of anterior teeth by putting reverse curve wire in incisal slot of twin slot bracket
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
assessment of smile Line ,smile arch, upper lip line , buccal corridor and amount of intrusion of maxillary incisor
Time Frame: 1year
|
standerized extra oral photograph and lateral cephalometric
|
1year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
percentage of deep bite correction
Time Frame: 1year
|
orthodontic study cast and lateral cephalometric
|
1year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Samir A Ibrahem, proffesor, Professor of orthodontics
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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)
December 10, 2022
Primary Completion (Actual)
August 10, 2024
Study Completion (Actual)
September 10, 2024
Study Registration Dates
First Submitted
November 1, 2024
First Submitted That Met QC Criteria
November 5, 2024
First Posted (Estimated)
November 7, 2024
Study Record Updates
Last Update Posted (Estimated)
November 7, 2024
Last Update Submitted That Met QC Criteria
November 5, 2024
Last Verified
November 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ORTHO-109-2-L
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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.
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