- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05341245
Graphene Oxide in the Surgical Management of Intrabony Periodontal Defects
April 17, 2022 updated by: Zeiad Khaled, Ain Shams University
Graphene Oxide in the Surgical Management of Intrabony Periodontal Defects: A Randomized Experimental Study With Histomorphometric Analysis
Using Graphene oxide in the surgical management of periodontal intrabony defects.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Evaluation of the effect of Graphene oxide in the surgical management of periodontal intrabony defects in animals in periodontal clinical parameters with histomorphometric evaluation .
Study Type
Interventional
Enrollment (Anticipated)
6
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 Contact
- Name: Zeiad Rashad
- Phone Number: 2001111309030
- Email: Zeiadkhaled2010@gmail.com
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
1 year to 2 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- male dogs
- 12-24 months old with approximate weight of 20-30 kg and general good health will be used
Exclusion Criteria:
-
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: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Graphene oxide group
The surgical defect will be managed by open flap debridement and application of Graphene oxide
|
Using Graphene oxide with open flap debridement in management of periodontal intrabony defects in dogs
|
Other: Open flap group
The surgical defect will be managed by open flap debridement
|
Using Open flap debridement in management of periodontal intrabony defects in dogs
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
periodontal probing depth
Time Frame: 2 months
|
To evaluate the use of Graphene Oxide in the surgical management of intrabony periodontal defects regarding the changes in periodontal probing depth "measured in mm " using University of North Carolina periodontal probe( UNC 15 probe ).
|
2 months
|
Clinical attachment level
Time Frame: 2 month
|
To evaluate the use of Graphene Oxide in the surgical management of intrabony periodontal defects regarding the changes in clinical attachment level "measured in mm " using University of North Carolina periodontal probe( UNC 15 probe )
|
2 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Histomorphometric evaluation
Time Frame: 2 months
|
To evaluate the use of Graphene Oxide in the surgical management of intrabony periodontal defects using histological sections obtained from the surgical site to do quantitative assessment of bone remodeling, modeling, and structure by "counting the number of osteoblasts and the number of bone trabeculae " using computer based microscope and software.
|
2 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 (Anticipated)
May 1, 2022
Primary Completion (Anticipated)
May 1, 2023
Study Completion (Anticipated)
June 1, 2023
Study Registration Dates
First Submitted
March 22, 2022
First Submitted That Met QC Criteria
April 17, 2022
First Posted (Actual)
April 22, 2022
Study Record Updates
Last Update Posted (Actual)
April 22, 2022
Last Update Submitted That Met QC Criteria
April 17, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1091
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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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