Back to resultsGraphene Oxide in the Surgical Management of Intrabony Periodontal Defects
Primary Purpose
Periodontal Diseases
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Graphene oxide and open flap debridement
Open flap debridement
Sponsored by
About this trial
This is an interventional treatment trial for Periodontal Diseases
Eligibility Criteria
Inclusion Criteria:
- male dogs
- 12-24 months old with approximate weight of 20-30 kg and general good health will be used
Exclusion Criteria:
-
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Graphene oxide group
Open flap group
Arm Description
The surgical defect will be managed by open flap debridement and application of Graphene oxide
The surgical defect will be managed by open flap debridement
Outcomes
Primary Outcome Measures
periodontal probing depth
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 ).
Clinical attachment level
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 )
Secondary Outcome Measures
Histomorphometric evaluation
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05341245
Brief Title
Graphene Oxide in the Surgical Management of Intrabony Periodontal Defects
Official Title
Graphene Oxide in the Surgical Management of Intrabony Periodontal Defects: A Randomized Experimental Study With Histomorphometric Analysis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 1, 2022 (Anticipated)
Primary Completion Date
May 1, 2023 (Anticipated)
Study Completion Date
June 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Using Graphene oxide in the surgical management of periodontal intrabony defects.
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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Graphene oxide group
Arm Type
Experimental
Arm Description
The surgical defect will be managed by open flap debridement and application of Graphene oxide
Arm Title
Open flap group
Arm Type
Other
Arm Description
The surgical defect will be managed by open flap debridement
Intervention Type
Procedure
Intervention Name(s)
Graphene oxide and open flap debridement
Intervention Description
Using Graphene oxide with open flap debridement in management of periodontal intrabony defects in dogs
Intervention Type
Procedure
Intervention Name(s)
Open flap debridement
Intervention Description
Using Open flap debridement in management of periodontal intrabony defects in dogs
Primary Outcome Measure Information:
Title
periodontal probing depth
Description
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 ).
Time Frame
2 months
Title
Clinical attachment level
Description
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 )
Time Frame
2 month
Secondary Outcome Measure Information:
Title
Histomorphometric evaluation
Description
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.
Time Frame
2 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
male dogs
12-24 months old with approximate weight of 20-30 kg and general good health will be used
Exclusion Criteria:
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zeiad Rashad
Phone
2001111309030
Email
Zeiadkhaled2010@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Graphene Oxide in the Surgical Management of Intrabony Periodontal Defects
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