Chronic PeriodontitisPhase 2NCT02594605
Applied The Platelet Rich Fibrin in Chronic Periodontitis
A Phase 2 study testing Platelet Rich Fibrin and Conventional Flap Surgery in people with Chronic Periodontitis, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
Platelet rich fibrin is a second generation platelet concentration which contains various growth factors. The aim of this study is to evaluate the clinical and biochemical efficacy of PRF in subjects of chronic periodontitis in the operation of conventional periodontal flap. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Chronic Periodontitis
- What is being tested?
- Platelet Rich Fibrin and Conventional Flap Surgery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Dec 2012to Dec 2013
- Phase
- Phase 2
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients with CP who had pocket depth ≤ 5 mm and at least two area (grouped as Control and PRF) with horizontal bone loss after Phase I therapy
Who cannot join
- The subjects excluded in the study had history of systemic disease, were smokers, had allergy to any drug, had need for prophylaxis of antibiotic and had taken antibiotics at least 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Contributions of Platelet Rich Fibrin Combined With Conventional Periodontal Flap on Periodontal Healing
Platelet rich fibrin is a second generation platelet concentration which contains various growth factors. The aim of this study is to evaluate the clinical and biochemical efficacy of PRF in subjects of chronic periodontitis in the operation of conventional periodontal flap.
Read the detailed description
PRF was developed in 2001 by Choukroun in France, it was the second generation fibrin adhesive, and was used to accelerate the soft and hard tissue healing. Many studies have shown beneficial effects of PRF on osteoconductive filler material in sinus lift operations, treatment of periodontal sulcus defect and treatment of furcation defects. Also PRF contains many growth factors. PRF accelerates periodontal regeneration through the gradually excreted growth factors and contributes to the bone regeneration. In this study, the investigators evaluated the effect of PRF on growth factors and its contribution to periodontal regeneration in subjects with chronic periodontitis.
- Conditions
- Chronic Periodontitis
- Being tested
- Platelet Rich Fibrin, Conventional Flap Surgery
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet Rich FibrinDevice
Platelet rich fibrin increases the growth factors. So it was applied for treatment of periodontal bone loss.
Conventional Flap SurgeryDevice
Only Conventional Flap Surgery treatment the bone loss limitedly.
| Study group | Role | What they receive |
|---|---|---|
| Platelet Rich Fibrin | Experimental | Platelet Rich Fibrin was applied with conventional flap surgery for treatment of periodontal bone loss in test group. Receives: Device: Platelet Rich Fibrin |
| Conventional Flap Surgery | Active comparator | Platelet Rich Fibrin was not applied to control groups. Only conventional flap surgery was applied to control groups. Receives: Device: Conventional Flap Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of IGF-1, VEGF, BMP-2, FGF-2 on Weekly
Change from baseline IGF-1, VEGF, BMP-2, FGF-2 levels of GCF at 1 month were measured by periopaper.
Measured: 4 weeks
Secondary outcomes (2)
Alteration of Clinical Attachment Level
Change from baseline Clinical Attachment Levels at 6 months were measured with periodontal probe.
Measured: 6 month
Alteration of Periodontal Pocket Depth
Change from baseline Pocket Depth at 6 months were measured with periodontal probe.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2015 (estimated)
- Study startDec 2012
- Primary completionJun 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic PeriodontitisStudies of the same condition, open and under way.
- More trials run by Ataturk 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alper KIZILDAĞ, Ataturk University
- Investigators
- Yasin ÇiÇEK, Study chair, Adiyaman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02594605
- Sponsor's protocol ID
- 385/2012
- Status last verified
- Dec 2012
- First submitted
- 15 Oct 2015
- Last updated
- 29 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bosshardt DD, Sculean A. Does periodontal tissue regeneration really work? Periodontol 2000. 2009;51:208-19. doi: 10.1111/j.1600-0757.2009.00317.x. No abstract available.
PubMed 19878476Kizildag A, Cicek Y, Arabaci T, Kose O. The effect of leukocyte-platelet-rich fibrin on bone morphogenetic protein-2 and insulin-like growth factor-1 levels in patients with chronic periodontitis: a randomized split mouth clinical trail. Growth Factors. 2018 Dec;36(5-6):239-245. doi: 10.1080/08977194.2018.1551217. Epub 2019 Jan 9.
PubMed 30624092
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Contributions of Platelet Rich Fibrin Combined With Conventional Periodontal Flap on Periodontal Healing
- ClinicalTrials.gov ID
- NCT02594605
- Acronym / sponsor ID
- 385/2012
- Conditions
- Chronic Periodontitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 3 Nov 2015 (estimated)
- 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 is a second generation platelet concentration which contains various growth factors. The aim of this study is to evaluate the clinical and biochemical efficacy of PRF in subjects of chronic periodontitis in the operation of conventional periodontal flap.
Detailed description
PRF was developed in 2001 by Choukroun in France, it was the second generation fibrin adhesive, and was used to accelerate the soft and hard tissue healing. Many studies have shown beneficial effects of PRF on osteoconductive filler material in sinus lift operations, treatment of periodontal sulcus defect and treatment of furcation defects. Also PRF contains many growth factors. PRF accelerates periodontal regeneration through the gradually excreted growth factors and contributes to the bone regeneration. In this study, the investigators evaluated the effect of PRF on growth factors and its contribution to periodontal regeneration in subjects with chronic periodontitis.
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 |
|---|---|---|
| Platelet Rich Fibrin | Experimental | Device: Platelet Rich FibrinPlatelet Rich Fibrin was applied with conventional flap surgery for treatment of periodontal bone loss in test group. |
| Conventional Flap Surgery | Active comparator | Device: Conventional Flap SurgeryPlatelet Rich Fibrin was not applied to control groups. Only conventional flap surgery was applied to control groups. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with CP who had pocket depth ≤ 5 mm and at least two area (grouped as Control and PRF) with horizontal bone loss after Phase I therapy
Key exclusion criteria (1 listed)
- The subjects excluded in the study had history of systemic disease, were smokers, had allergy to any drug, had need for prophylaxis of antibiotic and had taken antibiotics at least 6 months
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 FibrinPlatelet rich fibrin increases the growth factors. So it was applied for treatment of periodontal bone loss. | Device | Platelet Rich Fibrin |
| Conventional Flap SurgeryOnly Conventional Flap Surgery treatment the bone loss limitedly. | Device | Conventional Flap Surgery |
Primary outcome
Levels of IGF-1, VEGF, BMP-2, FGF-2 on Weekly
Time frame: 4 weeks
Change from baseline IGF-1, VEGF, BMP-2, FGF-2 levels of GCF at 1 month were measured by periopaper.
2 secondary outcomes
Alteration of Clinical Attachment Level
Time frame: 6 month
Alteration of Periodontal Pocket Depth
Time frame: 6 month
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 Aug 2016.
- Background: PubMed 19878476Bosshardt DD, Sculean A. Does periodontal tissue regeneration really work? Periodontol 2000. 2009;51:208-19. doi: 10.1111/j.1600-0757.2009.00317.x. No abstract available.
- Derived from this study: PubMed 30624092Kizildag A, Cicek Y, Arabaci T, Kose O. The effect of leukocyte-platelet-rich fibrin on bone morphogenetic protein-2 and insulin-like growth factor-1 levels in patients with chronic periodontitis: a randomized split mouth clinical trail. Growth Factors. 2018 Dec;36(5-6):239-245. doi: 10.1080/08977194.2018.1551217. Epub 2019 Jan 9.
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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.
Yasin ÇiÇEK study chair
Adiyaman University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Platelet Rich Fibrin and Conventional Flap Surgery in people with Chronic Periodontitis, run by Ataturk University at 1 site in Turkey (Türkiye).
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 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: finished, as of the sponsor's last update on 29 Aug 2016. 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 Turkey (Türkiye). 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Levels of IGF-1, VEGF, BMP-2, FGF-2 on Weekly (time frame: 4 weeks). 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 NCT02594605, which also lists 2 linked publications.
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 Aug 2016.