Periodontal PocketPhase 1NCT05958147
Concentrated Platelet Rich Fibrin (C-PRF) as Adjunct to Non-surgical Periodontal Therapy
A Phase 1 study testing C-PRF in people with Periodontal Pocket, run by Krishnadevaraya College of Dental Sciences & Hospital at 1 site in India.
Trial summary
The current study is a prospective randomised split mouth study to evaluate the effect of concentrated Platelet Rich Fibrin as an adjunct to the scaling and root planing Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Pocket
- What is being tested?
- C-PRF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteIndia
- Study dates
- 1 Feb 2023to 29 Mar 2023
- Phase
- Phase 1
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patient age ranging from 18-45 years
- Contralateral sites with probing depth 5mm-7mm associated with premolar and molar teeth with no furcation involvement
- No systemic disease
- Not under any medication which effect the outcome of periodontal therapy
Who cannot join
- History of any periodontal therapy within past 6 months
- Pregnant and lactating mothers
- Smokers smoking >10 cigarettes per day
- Patients with blood disorders or platelet count less than 50000 cells/ µL
- Patients with known systemic disease
- Non-compliant patients
Trial locations and contacts
1 site in 1 country.
India1 site
Krishnadevaraya college of dental sciences
Bangalore, Karnataka, 562157
About this study
Official title: Concentrated Platelet Rich Fibrin (C-PRF) as Adjunct to Non-surgical Periodontal Therapy- a Split Mouth Randomized Clinical Trail
The current study is a prospective randomised split mouth study to evaluate the effect of concentrated Platelet Rich Fibrin as an adjunct to the scaling and root planing
Read the detailed description
Twelve healthy individuals satisfying the inclusion and exclusion criteria were recruited for the study. A detailed, thorough medical and dental history was obtained and each patient was subjected to comprehensive clinical and radiological examination. All patients were informed about the nature of the study, procedure involved, potential benefits and risks associated with procedure and written informed consent were obtained from all patients.
All the patients underwent scaling and root planing. As it is split mouth study design the test site is treated with Concentrated platelet rich fibrin( C-PRF) and the contralateral site is not treated with C-PRF. Periodotal pack was placed and patient was recalled after 6 weeks for the follow up.
- Conditions
- Periodontal Pocket
- Being tested
- C-PRF
- Medical subject headings
- Periodontal Pocket
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-PRFBiological
Also called Concentrated platelet rich fibrin
thorough scaling and root planing is performed followed by withdraw of 5ml of blood from antecubital vein of patient with consent . Following C-PRF protocol of 3000rpm for 8 min centrifugation is performed. 1ml of plasma is drawn from the test tube just above the red blood cell layer and allowed to clot and the formed clot is placed in the periodontal pocket after scaling and root planing
| Study group | Role | What they receive |
|---|---|---|
| Probing sites with SPR and C-PRF application | Experimental | The test group received the C-PRF as adjunct to sacling and root planing Receives: Biological: C-PRF |
| Probing sites with SPR alone | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing pocket Depth
measured using a UNC-15 probe (university of North Carolina-15 periodontal probe- Hu-Friedy, Chicago, IL, USA)
Measured: 6 weeks
Relative attachment level
measured by placing the acrylic stent on the selected teeth using UNC-15 probe (university of North Carolina-15 periodontal probe- Hu-Friedy, Chicago, IL, USA)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2023
- Study start1 Feb 2023
- Primary completion23 Mar 2023
- Study completion29 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal PocketStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Krishnadevaraya College of Dental Sciences & Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05958147
- Sponsor's protocol ID
- KCDSHEC/IP/2023/P7
- Status last verified
- Sep 2023
- First submitted
- 14 Jul 2023
- Last updated
- 15 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concentrated Platelet Rich Fibrin (C-PRF) as Adjunct to Non-surgical Periodontal Therapy- a Split Mouth Randomized Clinical Trail
- ClinicalTrials.gov ID
- NCT05958147
- Acronym / sponsor ID
- KCDSHEC/IP/2023/P7
- Conditions
- Periodontal Pocket
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Krishnadevaraya College of Dental Sciences & HospitalUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 23 Mar 2023 (actual)
- Study completion
- 29 Mar 2023 (actual)
- First posted
- 24 Jul 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.
The current study is a prospective randomised split mouth study to evaluate the effect of concentrated Platelet Rich Fibrin as an adjunct to the scaling and root planing
Detailed description
Twelve healthy individuals satisfying the inclusion and exclusion criteria were recruited for the study. A detailed, thorough medical and dental history was obtained and each patient was subjected to comprehensive clinical and radiological examination. All patients were informed about the nature of the study, procedure involved, potential benefits and risks associated with procedure and written informed consent were obtained from all patients.
All the patients underwent scaling and root planing. As it is split mouth study design the test site is treated with Concentrated platelet rich fibrin( C-PRF) and the contralateral site is not treated with C-PRF. Periodotal pack was placed and patient was recalled after 6 weeks for the follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probing sites with SPR and C-PRF application | Experimental | Biological: C-PRFThe test group received the C-PRF as adjunct to sacling and root planing |
| Probing sites with SPR alone | No intervention | – |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patient age ranging from 18-45 years
- Contralateral sites with probing depth 5mm-7mm associated with premolar and molar teeth with no furcation involvement
- No systemic disease
- Not under any medication which effect the outcome of periodontal therapy
Key exclusion criteria (6 listed)
- History of any periodontal therapy within past 6 months
- Pregnant and lactating mothers
- Smokers smoking >10 cigarettes per day
- Patients with blood disorders or platelet count less than 50000 cells/ µL
- Patients with known systemic disease
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 |
|---|---|---|
| C-PRFAlso: Concentrated platelet rich fibrinthorough scaling and root planing is performed followed by withdraw of 5ml of blood from antecubital vein of patient with consent . Following C-PRF protocol of 3000rpm for 8 min centrifugation is performed. 1ml of plasma is drawn from the test tube just above the red blood cell layer and allowed to clot and the formed clot is placed in the periodontal pocket after scaling and root planing | Biological | Probing sites with SPR and C-PRF application |
Primary outcome
Probing pocket Depth
Time frame: 6 weeks
measured using a UNC-15 probe (university of North Carolina-15 periodontal probe- Hu-Friedy, Chicago, IL, USA)
Relative attachment level
Time frame: 6 weeks
measured by placing the acrylic stent on the selected teeth using UNC-15 probe (university of North Carolina-15 periodontal probe- Hu-Friedy, Chicago, IL, USA)
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 15 Sep 2023.
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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 Phase 1 study testing C-PRF in people with Periodontal Pocket, run by Krishnadevaraya College of Dental Sciences & Hospital at 1 site in India.
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 4 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 15 Sep 2023. 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 India. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Probing pocket Depth (time frame: 6 weeks). 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 15 Sep 2023.