- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05002283
Accuracy of Computer Guided Free Gingival Graft
August 4, 2021 updated by: Mohamed Shawky, Cairo University
A patient specific surgical guide for harvesting of free gingival graft from the palate
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
10
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
- Faculty of Dentistry
-
-
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 46 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- patients with intraoral alveolar defect requiring soft tissue augmentation
Exclusion Criteria:
- - patients with systemic diseases interfering with surgical interventions
- - Poor oral hygiene
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 |
|---|---|
|
Experimental: Study group
the patients undergo free gingival graft harvest from the palate using a patient specific guide
|
harvesting palatal free gingival graft using the patient specific guide
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Accuracy of the guide
Time Frame: One month
|
accuracy of the predefined graft dimensions relative to the required dimensions of the recipient site in millimetres
|
One month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mohamed Shawky, MSc, Investigator
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)
August 1, 2020
Primary Completion (Actual)
July 31, 2021
Study Completion (Actual)
August 1, 2021
Study Registration Dates
First Submitted
August 1, 2021
First Submitted That Met QC Criteria
August 4, 2021
First Posted (Actual)
August 12, 2021
Study Record Updates
Last Update Posted (Actual)
August 12, 2021
Last Update Submitted That Met QC Criteria
August 4, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- OMFS 3-3-5
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
the IPD will be made available upon request from the author
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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