PeriodontitisNCT05890157
Treatment Of Shallow Periodontal Pockets Using PRF As an Adjunct To Scaling And Root Planing In Periodontitis Patients
A study testing PRF in people with Periodontitis, run by University of Baghdad.
Trial summary
Platelet rich fibrin (PRF) has been widely used in regenerative dentistry since it provides plenty amount of growth factors that enhance wound healing and tissue regeneration. Platelet derived growth factor-BB (PDGF-BB) is a growth factor with essential functions such as regulation of cell migration, proliferation… Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- PRF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 30 Jul 2023to 30 Dec 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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- •periodontitis
Who cannot join
- Periodontal therapy for the last 3 months
- Medical history of systemic diseases such as diabetes.
- Patients wearing dental prosthesis
- Alcoholic patients
- Teeth with grade II mobility, endodontic lesions, and teeth with untreated caries
About this study
Official title: Treatment Of Shallow Periodontal Pockets Using PRF As an Adjunct To Scaling And Root Planing In Periodontitis Patients, Randomized Clinical Trial
Platelet rich fibrin (PRF) has been widely used in regenerative dentistry since it provides plenty amount of growth factors that enhance wound healing and tissue regeneration. Platelet derived growth factor-BB (PDGF-BB) is a growth factor with essential functions such as regulation of cell migration, proliferation, and differentiation. This study aims to evaluate the efficacy of PRF in improving the clinical periodontal parameters and GCF level of PDGF-BB.
Read the detailed description
Split mouth randomized clinical trial is the design of the study. 12 periodontitis patients with 24 opposite shallow periodontal pockets (4-6 mm in depth) will be selected. Randomization in this study will be achieved using toss of coin method in which periodontal pockets will be designated either control site or test site. PRF will be used as an adjunct to scaling and root planing to treat the test sites. While control sites were treated by scaling and root planing only. Clinal periodontal parameters were recorded and GCF level of PDGF-BB will be measured at baseline and1- and 3- month follow-up visits to evaluate the healing response to the treatment.
- Conditions
- Periodontitis
- Being tested
- PRF
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRFOther
Split mouth randomized clinical trial will be the design of the study. 12 periodontitis patients with 24 opposite shallow periodontal pockets (4-6 mm in depth) will be selected. Randomization in this study will be achieved using toss of coin method in which periodontal pockets were designated either control site or test site. PRF will be used as an adjunct to scaling and root planing to treat the test sites. While control sites will be treated by scaling and root planing only. Clinal periodontal parameters will be recorded and GCF level of PDGF-BB will be measured at baseline and1- and 3- month follow-up visits to evaluate the healing response to the treatment.
| Study group | Role | What they receive |
|---|---|---|
| Test ScRp+PRF | Experimental | This site will treated by ScRp+PRF Receives: Other: PRF |
| Control ScRp | No intervention | This site will treated by ScRp only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Clinical attachment level
Using UNC-15 periodontal probe measured in mm
Measured: Change from baseline to 1-month and change from baseline to 3-month
Change in Periodontal pocket depth measured in mm
Using UNC-15 periodontal probe measured in mm
Measured: Change from baseline to 1-month and change from baseline to 3-month
Secondary outcomes (3)
Change in plaque index
Using Sinless and Loe 1964 plaque index scores
Measured: Change from baseline to 1-month and change from baseline to 3-month
Change in bleeding on probing percentage
Using UNC-15 periodontal probe
Measured: Change from baseline to 1-month and change from baseline to 3-month
Change in GCF level of platelet derived growth factor
Using periocol paper to collect GCF and analysed by ELISA test
Measured: Change from baseline to 1-month and change from baseline to 3-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2023
- Study start30 Jul 2023 (estimated)
- Primary completion30 Nov 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 12 participants (estimated)
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
- NCT05890157
- Sponsor's protocol ID
- PRF as adjunct to ScRp
- Status last verified
- May 2023
- First submitted
- 16 May 2023
- Last updated
- 6 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Al-Rihaymee S, Mahmood MS, Abdulbaqi HR, Majeed ZN. Platelet-rich fibrin as an adjunct to scaling and root planing in treatment of shallow periodontal pockets: A randomized clinical trial. J Oral Biosci. 2024 Sep;66(3):612-618. doi: 10.1016/j.job.2024.07.002. Epub 2024 Jul 10.
PubMed 38997108
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Of Shallow Periodontal Pockets Using PRF As an Adjunct To Scaling And Root Planing In Periodontitis Patients, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05890157
- Acronym / sponsor ID
- PRF as adjunct to ScRp
- Conditions
- Periodontitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 30 Jul 2023 (estimated)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 6 Jun 2023 (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.
Platelet rich fibrin (PRF) has been widely used in regenerative dentistry since it provides plenty amount of growth factors that enhance wound healing and tissue regeneration. Platelet derived growth factor-BB (PDGF-BB) is a growth factor with essential functions such as regulation of cell migration, proliferation, and differentiation. This study aims to evaluate the efficacy of PRF in improving the clinical periodontal parameters and GCF level of PDGF-BB.
Detailed description
Split mouth randomized clinical trial is the design of the study. 12 periodontitis patients with 24 opposite shallow periodontal pockets (4-6 mm in depth) will be selected. Randomization in this study will be achieved using toss of coin method in which periodontal pockets will be designated either control site or test site. PRF will be used as an adjunct to scaling and root planing to treat the test sites. While control sites were treated by scaling and root planing only. Clinal periodontal parameters were recorded and GCF level of PDGF-BB will be measured at baseline and1- and 3- month follow-up visits to evaluate the healing response to the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test ScRp+PRF | Experimental | Other: PRFThis site will treated by ScRp+PRF |
| Control ScRp | No intervention | –This site will treated by ScRp only |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- •periodontitis
Key exclusion criteria (5 listed)
- Periodontal therapy for the last 3 months
- Medical history of systemic diseases such as diabetes.
- Patients wearing dental prosthesis
- Alcoholic patients
- Teeth with grade II mobility, endodontic lesions, and teeth with untreated caries
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 |
|---|---|---|
| PRFSplit mouth randomized clinical trial will be the design of the study. 12 periodontitis patients with 24 opposite shallow periodontal pockets (4-6 mm in depth) will be selected. Randomization in this study will be achieved using toss of coin method in which periodontal pockets were designated either control site or test site. PRF will be used as an adjunct to scaling and root planing to treat the test sites. While control sites will be treated by scaling and root planing only. Clinal periodontal parameters will be recorded and GCF level of PDGF-BB will be measured at baseline and1- and 3- month follow-up visits to evaluate the healing response to the treatment. | Other | Test ScRp+PRF |
Primary outcome
Change in Clinical attachment level
Time frame: Change from baseline to 1-month and change from baseline to 3-month
Using UNC-15 periodontal probe measured in mm
Change in Periodontal pocket depth measured in mm
Time frame: Change from baseline to 1-month and change from baseline to 3-month
Using UNC-15 periodontal probe measured in mm
3 secondary outcomes
Change in plaque index
Time frame: Change from baseline to 1-month and change from baseline to 3-month
Change in bleeding on probing percentage
Time frame: Change from baseline to 1-month and change from baseline to 3-month
Change in GCF level of platelet derived growth factor
Time frame: Change from baseline to 1-month and change from baseline to 3-month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2023.
- Derived from this study: PubMed 38997108Al-Rihaymee S, Mahmood MS, Abdulbaqi HR, Majeed ZN. Platelet-rich fibrin as an adjunct to scaling and root planing in treatment of shallow periodontal pockets: A randomized clinical trial. J Oral Biosci. 2024 Sep;66(3):612-618. doi: 10.1016/j.job.2024.07.002. Epub 2024 Jul 10.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing PRF in people with Periodontitis, run by University of Baghdad.
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 1 inclusion and 5 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 6 Jun 2023. 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?
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?
Change in Clinical attachment level (time frame: Change from baseline to 1-month and change from baseline to 3-month). 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?
On the ClinicalTrials.gov record for NCT05890157, which also lists 1 linked publication.
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 6 Jun 2023.