- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06045871
Evaluation of Surgical Correction of Anterior Vertical Maxillary Excess (Gummy Smile) by Compression Osteogenesis.
September 13, 2023 updated by: Marwa Samir El-helaly, Cairo University
Evaluation of Surgical Correction of Anterior Vertical Maxillary Excess (Gummy Smile) by Compression.
The technique of compression osteogenesis will be studied to verify its value as applied to manage anterior vertical maxillary excess in patients wohm are suffering from gummy smile.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
5
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, 02
- Marwa Elhelaly
-
-
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
Yes
Description
Inclusion Criteria:
- patients suffering from anterior vertical maxillary excess that requires surgical intervention
Exclusion Criteria:
- total vertical maxillary excess Excessive horizontal maxillary excess Patients with systemic diseases that may affect normal bone healing
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Patients with anterior vertical maxillary excess (gummy smile)
|
Surgical corticotomy supra apical in anterior maxilla then application of the compression osteogenesis concept via traction on miniscrews implanted above the corticotomy line
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Measuring amount of vertical impaction of anterior maxilla after performing labial maxillary cotricotomy and activation of functional loading
Time Frame: 3 months
|
Measuring amount of linear impaction (in millimeters) to evaluate validity of compression osteogenesis in treating gummy smile of a skeletal etiology ( due to increased anterior maxilla height) after performing labia maxillary corticotomy and activating functional loading using power chain elastics anchored on transmucosal mini- screws.
|
3 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)
January 31, 2022
Primary Completion (Actual)
August 22, 2022
Study Completion (Actual)
February 2, 2023
Study Registration Dates
First Submitted
September 4, 2023
First Submitted That Met QC Criteria
September 13, 2023
First Posted (Actual)
September 21, 2023
Study Record Updates
Last Update Posted (Actual)
September 21, 2023
Last Update Submitted That Met QC Criteria
September 13, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- OMFS 3.3.2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
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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