PeriodontitisNCT03027050
T-PRF Provides Advantages on Periodontal Healing: A Split Mouth Clinical Study
A study testing T-PRF and Open Flap Debridement alone in people with Periodontitis and Periodontal Attachment Loss, run by Ataturk University.
Trial summary
It was aimed to evaluate the contributions of T-PRF treatment combined with open flap debridement on biological markers in GCF and periodontal outcomes in chronic periodontitis patients. 29 patients (58 sites) with chronic periodontitis were treated either with autologous T-PRF with OFD or OFD alone. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Periodontal Attachment Loss
- What is being tested?
- T-PRF and Open Flap Debridement alone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to Nov 2016
- 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 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 initial treatment
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
About this study
Official title: T-PRF Contributes to Periodontal Healing
It was aimed to evaluate the contributions of T-PRF treatment combined with open flap debridement on biological markers in GCF and periodontal outcomes in chronic periodontitis patients. 29 patients (58 sites) with chronic periodontitis were treated either with autologous T-PRF with OFD or OFD alone. GCF growth factor levels and relative RANKL/OPG ratio at baseline and 2, 4 and 6 weeks postoperatively were analyzed, and clinical parameters such as probing depth (PD), relative attachment level (RAL) and gingival margin level (GML) at baseline and 9 months after surgery were compromised.
Read the detailed description
A total of 29 medically healthy patients (12 females and 17 males; age range 28-49 years, mean±SD: 38.22±8.21) with chronic periodontitis at the outpatient Ataturk University, Department of Periodontology, Faculty of Dentistry, Erzurum, Turkey, were selected for the study. The study, conducted from November 2015 to June 2016, was planned as a randomized, double-blinded, controlled clinical trial that used a split-mouth design. This study was proved by the ethics committee of Ataturk University Faculty of Dentistry, and all patients received verbal information regarding participation and provided written informed consent for including to the study.
Bone loss characteristics of the patients were diagnosed with full-mouth radiographs and cone-beam computed tomography. This study included the patients with moderate-to-severe chronic periodontitis with a probing depth of 5 mm or deeper and horizontal bone loss (one- or two-wall shallow interproximal defects) of at least two quadrants of the jaws after Phase-I periodontal therapy. After re-evaluating the results of Phase-I therapy, patients with any of the following were excluded from the study: 1) smoking or tobacco use in any form; 2) medications known to affect periodontal treatment and blood coagulation; 3) systemic conditions known to affect periodontal status; 4) pregnancy/lactation; and 5) poor oral hygiene (plaque index [PI] >1.5) (Sillness and Loe; 1964). Patients with teeth with 3-wall intrabony defects, gingival recession, endodontic lesion, or furcation involvement were also excluded.
- Conditions
- Periodontitis, Periodontal Attachment Loss
- Being tested
- T-PRF, Open Flap Debridement alone
- Keywords
- periodontitis, Growth factors, Periodontal healing
- Medical subject headings
- Periodontitis, Periodontal Attachment Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T-PRFProcedure or surgery
Applied for treatment of periodontal bone loss.
Open Flap Debridement aloneProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Titanium-prepared platelet rich fibrine | Experimental | T-PRF was applied with open flap debridement in test group. Receives: Procedure: T-PRF; Procedure: Open Flap Debridement alone |
| Open Flap Debridement alone | Active comparator | T-PRF was not applied to control groups. Only open flap debridement was applied to control groups. Receives: Procedure: T-PRF; Procedure: Open Flap Debridement alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of Growth Factor
Change from baseline growth factors levels of GCF at 6 weeks were measured by periopaper
Measured: 6 weeks
Secondary outcomes (4)
relative RANKL/OPG ratio in GCF
Change in relative RANKL/OPG ratio from baseline to 6 weeks were measured by periopaper
Measured: 6 weeks
Alteration of Clinical Attachment Level
Change from baseline Clinical Attachment Levels at 9 months were measured with periodontal probe.
Measured: 9 months
Alteration of Periodontal Pocket Depth
Change from baseline Pocket Depth at 9 months were measured with periodontal probe.
Measured: 9 months
Gingival Margin Level
Change from baseline to 9 months were measured with periodontal probe.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2017 (estimated)
- Study startNov 2015
- Primary completionJun 2016
- Study completionNov 2016
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 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Taner ARABACI, Ataturk University
- Investigators
- Taner Arabacı, Principal investigator, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03027050
- Sponsor's protocol ID
- BAP-2011301
- Status last verified
- Jan 2017
- First submitted
- 17 Jan 2017
- Last updated
- 20 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Pradeep AR, Shetty SK, Garg G, Pai S. Clinical effectiveness of autologous platelet-rich plasma and Peptide-enhanced bone graft in the treatment of intrabony defects. J Periodontol. 2009 Jan;80(1):62-71. doi: 10.1902/jop.2009.080214.
PubMed 19228091
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- T-PRF Contributes to Periodontal Healing
- ClinicalTrials.gov ID
- NCT03027050
- Acronym / sponsor ID
- BAP-2011301
- Conditions
- Periodontitis, Periodontal Attachment Loss
- Keywords
- periodontitis, Growth factors, Periodontal healing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 20 Jan 2017 (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.
It was aimed to evaluate the contributions of T-PRF treatment combined with open flap debridement on biological markers in GCF and periodontal outcomes in chronic periodontitis patients. 29 patients (58 sites) with chronic periodontitis were treated either with autologous T-PRF with OFD or OFD alone. GCF growth factor levels and relative RANKL/OPG ratio at baseline and 2, 4 and 6 weeks postoperatively were analyzed, and clinical parameters such as probing depth (PD), relative attachment level (RAL) and gingival margin level (GML) at baseline and 9 months after surgery were compromised.
Detailed description
A total of 29 medically healthy patients (12 females and 17 males; age range 28-49 years, mean±SD: 38.22±8.21) with chronic periodontitis at the outpatient Ataturk University, Department of Periodontology, Faculty of Dentistry, Erzurum, Turkey, were selected for the study. The study, conducted from November 2015 to June 2016, was planned as a randomized, double-blinded, controlled clinical trial that used a split-mouth design. This study was proved by the ethics committee of Ataturk University Faculty of Dentistry, and all patients received verbal information regarding participation and provided written informed consent for including to the study.
Bone loss characteristics of the patients were diagnosed with full-mouth radiographs and cone-beam computed tomography. This study included the patients with moderate-to-severe chronic periodontitis with a probing depth of 5 mm or deeper and horizontal bone loss (one- or two-wall shallow interproximal defects) of at least two quadrants of the jaws after Phase-I periodontal therapy. After re-evaluating the results of Phase-I therapy, patients with any of the following were excluded from the study: 1) smoking or tobacco use in any form; 2) medications known to affect periodontal treatment and blood coagulation; 3) systemic conditions known to affect periodontal status; 4) pregnancy/lactation; and 5) poor oral hygiene (plaque index [PI] >1.5) (Sillness and Loe; 1964). Patients with teeth with 3-wall intrabony defects, gingival recession, endodontic lesion, or furcation involvement were also excluded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Titanium-prepared platelet rich fibrine | Experimental | Procedure: T-PRF, Procedure: Open Flap Debridement aloneT-PRF was applied with open flap debridement in test group. |
| Open Flap Debridement alone | Active comparator | Procedure: T-PRF, Procedure: Open Flap Debridement aloneT-PRF was not applied to control groups. Only open flap debridement 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 initial treatment
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 |
|---|---|---|
| T-PRFApplied for treatment of periodontal bone loss. | Procedure or surgery | Open Flap Debridement alone, Titanium-prepared platelet rich fibrine |
| Open Flap Debridement alone | Procedure or surgery | Open Flap Debridement alone, Titanium-prepared platelet rich fibrine |
Primary outcome
Level of Growth Factor
Time frame: 6 weeks
Change from baseline growth factors levels of GCF at 6 weeks were measured by periopaper
4 secondary outcomes
relative RANKL/OPG ratio in GCF
Time frame: 6 weeks
Alteration of Clinical Attachment Level
Time frame: 9 months
Alteration of Periodontal Pocket Depth
Time frame: 9 months
Gingival Margin Level
Time frame: 9 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 20 Jan 2017.
- Background: PubMed 19228091Pradeep AR, Shetty SK, Garg G, Pai S. Clinical effectiveness of autologous platelet-rich plasma and Peptide-enhanced bone graft in the treatment of intrabony defects. J Periodontol. 2009 Jan;80(1):62-71. doi: 10.1902/jop.2009.080214.
- 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.
Taner Arabacı principal investigator
Ataturk University
Questions about this trial
What is this clinical trial studying?
A study testing T-PRF and Open Flap Debridement alone in people with Periodontitis and Periodontal Attachment Loss, run by Ataturk 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 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 20 Jan 2017. 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?
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?
Level of Growth Factor (time frame: 6 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 NCT03027050, 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 20 Jan 2017.