Periodontal DiseasesNCT05341245
Graphene Oxide in the Surgical Management of Intrabony Periodontal Defects
A study testing Graphene oxide and open flap debridement and Open flap debridement in people with Periodontal Diseases, run by Ain Shams University.
Trial summary
Using Graphene oxide in the surgical management of periodontal intrabony defects. Read more about this study
- Who is it for?
- Ages 1 year to 2 years, men only
- Conditions the study is for
- Periodontal Diseases
- What is being tested?
- Graphene oxide and open flap debridement and Open flap debridement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2022to 1 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 2 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- male dogs
- 12-24 months old with approximate weight of 20-30 kg and general good health will be used
Who cannot join
- -
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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 .
- Conditions
- Periodontal Diseases
- Being tested
- Graphene oxide and open flap debridement, Open flap debridement
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Graphene oxide and open flap debridementProcedure or surgery
Using Graphene oxide with open flap debridement in management of periodontal intrabony defects in dogs
Open flap debridementProcedure or surgery
Using Open flap debridement in management of periodontal intrabony defects in dogs
| Study group | Role | What they receive |
|---|---|---|
| Graphene oxide group | Experimental | The surgical defect will be managed by open flap debridement and application of Graphene oxide Receives: Procedure: Graphene oxide and open flap debridement |
| Open flap group | Other | The surgical defect will be managed by open flap debridement Receives: Procedure: Open flap debridement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 ).
Measured: 2 months
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 )
Measured: 2 month
Secondary outcomes (1)
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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start1 May 2022 (estimated)
- Primary completion1 May 2023 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeiad Khaled, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05341245
- Sponsor's protocol ID
- 1091
- Status last verified
- Apr 2022
- First submitted
- 22 Mar 2022
- Last updated
- 22 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Graphene Oxide in the Surgical Management of Intrabony Periodontal Defects: A Randomized Experimental Study With Histomorphometric Analysis
- ClinicalTrials.gov ID
- NCT05341245
- Acronym / sponsor ID
- 1091
- Conditions
- Periodontal Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (estimated)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 22 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Graphene oxide group | Experimental | Procedure: Graphene oxide and open flap debridementThe surgical defect will be managed by open flap debridement and application of Graphene oxide |
| Open flap group | Other | Procedure: Open flap debridementThe surgical defect will be managed by open flap debridement |
Who may qualify
- Ages
- 1 year to 2 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- male dogs
- 12-24 months old with approximate weight of 20-30 kg and general good health will be used
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Graphene oxide and open flap debridementUsing Graphene oxide with open flap debridement in management of periodontal intrabony defects in dogs | Procedure or surgery | Graphene oxide group |
| Open flap debridementUsing Open flap debridement in management of periodontal intrabony defects in dogs | Procedure or surgery | Open flap group |
Primary outcome
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 ).
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 )
1 secondary outcome
Histomorphometric evaluation
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Graphene oxide and open flap debridement and Open flap debridement in people with Periodontal Diseases, run by Ain Shams University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zeiad Rashad (2001111309030, Zeiadkhaled2010@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
periodontal probing depth (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2022.