PeriodontitisNCT05178771
Efficacy of PRF Application on Clinical Parameters and GCF Platelet-derived Growth Factor-BB and Periostin Levels
A study testing Platelet rich fibrin in people with Periodontitis, run by University of Baghdad at 1 site in Iraq.
Trial summary
Determine the efficacy of the non-invasive application of PRF on periodontal clinical parameters(pocket reduction) and the levels of PDGF-BB and Periostin in the gingival crevicular fluid. Read more about this study
- Who is it for?
- Ages 15 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- Platelet rich fibrin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteIraq
- Study dates
- 1 Mar 2022to 25 Sep 2022
- 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 15 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Systemically healthy patients.
- Patients with periodontitis.
Who cannot join
- Medical history of systemic disease: diabetes, pregnancy, or lactation.
- Previous periodontal treatment for the last 6 months
- Grade II mobility
- Smoker or alcoholic patient.
- Teeth with untreated caries, endodontic lesions
- Symptoms of recent acute illness e.g., COVID-19 will be excluded as well
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Application of Platelet-rich Fibrin on Periodontal Clinical Parameters and Gingival Crevicular Fluid Platelet-derived Growth Factor-BB and Periostin Levels
Determine the efficacy of the non-invasive application of PRF on periodontal clinical parameters(pocket reduction) and the levels of PDGF-BB and Periostin in the gingival crevicular fluid.
Read the detailed description
The adjunctive use of PRF with conventional ScRp may improve clinical healing, decrease tissue morbidities such as pain and discomfort, increase patient acceptance, reduce treatment time. Since PRF can be utilized as a safe, natural method to repair tissues at a low cost. Our aim is to evaluate the effectiveness of the non-invasive application of PRF as an adjunct to ScRp in patients with stage III grade B periodontitis through measurements of gingival crevicular fluid levels of PDGF-BB and Periostin before and after treatment and compare it with ScRp alone. A split-mouth procedure will be performed to reduce confounders as possible.
- Conditions
- Periodontitis
- Being tested
- Platelet rich fibrin
- Keywords
- PRF, PDGF-BB, Periostin
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet rich fibrinOther
- Intravenous blood (obtained by venipuncture of the antecubital vein) will be collected in two 10-mL sterile tubes without any anticoagulants and will be immediately centrifuged at 3,000 revolutions (400 × g) per minute for 10 minutes.
- A structured fibrin clot in the middle of the tube, just between the red corpuscles (RBCs) at the bottom and the acellular plasma at the top, will be separated from the RBCs using sterile tweezers and scissors and transferred on a sterile PRF box.
- The PRF will be then brought to a thickness of 1 mm by gently compressing in PRF box. Standardized PRF pieces will be obtained by measuring by a periodontal probe and cutting into 3 × 5 mm dimensions.
- The PRF pieces will be inserted into the periodontal pockets by filling the pockets from the base up to the gingival margin. A modified gingivectomy knife, of which the tip is made blunt, will be used.
The PRF volume will be calculated by recording how many pieces will be inserted.
| Study group | Role | What they receive |
|---|---|---|
| test site | Experimental | The test site will receive ScRp in addition to PRF Receives: Other: Platelet rich fibrin |
| control sites | No intervention | The control site will be treated by ScRp only |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical parameters
measurements of pocket depth in millimeter at baseline and at the end of study
Measured: 4 weeks and 3 months
Secondary outcomes (1)
PDGF-BB and periostin level in GCF
Measurement of PDGF-BB and periostin level in GCF in baseline data and at the end of study
Measured: 4 weeks and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2022
- Study start1 Mar 2022
- Primary completion5 Aug 2022
- Study completion25 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by University of BaghdadThe 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
- Model description
- A split-mouth procedure will be formed. Two quadrants in each participant will be selected; the sites will be divided into two groups: control site( will treat by ScRp only) and test sites( will treat by ScRp and PRF)
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Alrihaymee, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05178771
- Sponsor's protocol ID
- PRF effect on perio-parameters
- Status last verified
- Sep 2022
- First submitted
- 16 Dec 2021
- Last updated
- 29 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Application of Platelet-rich Fibrin on Periodontal Clinical Parameters and Gingival Crevicular Fluid Platelet-derived Growth Factor-BB and Periostin Levels
- ClinicalTrials.gov ID
- NCT05178771
- Acronym / sponsor ID
- PRF effect on perio-parameters
- Conditions
- Periodontitis
- Keywords
- PRF, PDGF-BB, Periostin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 5 Aug 2022 (actual)
- Study completion
- 25 Sep 2022 (actual)
- First posted
- 5 Jan 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.
Determine the efficacy of the non-invasive application of PRF on periodontal clinical parameters(pocket reduction) and the levels of PDGF-BB and Periostin in the gingival crevicular fluid.
Detailed description
The adjunctive use of PRF with conventional ScRp may improve clinical healing, decrease tissue morbidities such as pain and discomfort, increase patient acceptance, reduce treatment time. Since PRF can be utilized as a safe, natural method to repair tissues at a low cost. Our aim is to evaluate the effectiveness of the non-invasive application of PRF as an adjunct to ScRp in patients with stage III grade B periodontitis through measurements of gingival crevicular fluid levels of PDGF-BB and Periostin before and after treatment and compare it with ScRp alone. A split-mouth procedure will be performed to reduce confounders as possible.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- A split-mouth procedure will be formed. Two quadrants in each participant will be selected; the sites will be divided into two groups: control site( will treat by ScRp only) and test sites( will treat by ScRp and PRF)
| Arm | Type | Receives |
|---|---|---|
| test site | Experimental | Other: Platelet rich fibrinThe test site will receive ScRp in addition to PRF |
| control sites | No intervention | –The control site will be treated by ScRp only |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Systemically healthy patients.
- Patients with periodontitis.
Key exclusion criteria (6 listed)
- Medical history of systemic disease: diabetes, pregnancy, or lactation.
- Previous periodontal treatment for the last 6 months
- Grade II mobility
- Smoker or alcoholic patient.
- Teeth with untreated caries, endodontic lesions
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 |
|---|---|---|
| Platelet rich fibrin1. Intravenous blood (obtained by venipuncture of the antecubital vein) will be collected in two 10-mL sterile tubes without any anticoagulants and will be immediately centrifuged at 3,000 revolutions (400 × g) per minute for 10 minutes. 2. A structured fibrin clot in the middle of the tube, just between the red corpuscles (RBCs) at the bottom and the acellular plasma at the top, will be separated from the RBCs using sterile tweezers and scissors and transferred on a sterile PRF box. 3. The PRF will be then brought to a thickness of 1 mm by gently compressing in PRF box. Standardized PRF pieces will be obtained by measuring by a periodontal probe and cutting into 3 × 5 mm dimensions. 4. The PRF pieces will be inserted into the periodontal pockets by filling the pockets from the base up to the gingival margin. A modified gingivectomy knife, of which the tip is made blunt, will be used. The PRF volume will be calculated by recording how many pieces will be inserted. | Other | test site |
Primary outcome
clinical parameters
Time frame: 4 weeks and 3 months
measurements of pocket depth in millimeter at baseline and at the end of study
1 secondary outcome
PDGF-BB and periostin level in GCF
Time frame: 4 weeks and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Platelet rich fibrin in people with Periodontitis, run by University of Baghdad at 1 site in Iraq.
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 6 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: finished, as of the sponsor's last update on 29 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical parameters (time frame: 4 weeks and 3 months). 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 29 Sep 2022.