T-PRF Provides Advantages on Periodontal Healing: A Split Mouth Clinical Study
Primary Purpose
Periodontitis, Periodontal Attachment Loss
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
T-PRF
Open Flap Debridement alone
Sponsored by
About this trial
This is an interventional treatment trial for Periodontitis focused on measuring periodontitis, Growth factors, Periodontal healing
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Titanium-prepared platelet rich fibrine
Open Flap Debridement alone
Arm Description
T-PRF was applied with open flap debridement in test group.
T-PRF was not applied to control groups. Only open flap debridement was applied to control groups.
Outcomes
Primary Outcome Measures
Level of Growth Factor
Change from baseline growth factors levels of GCF at 6 weeks were measured by periopaper
Secondary Outcome Measures
relative RANKL/OPG ratio in GCF
Change in relative RANKL/OPG ratio from baseline to 6 weeks were measured by periopaper
Alteration of Clinical Attachment Level
Change from baseline Clinical Attachment Levels at 9 months were measured with periodontal probe.
Alteration of Periodontal Pocket Depth
Change from baseline Pocket Depth at 9 months were measured with periodontal probe.
Gingival Margin Level
Change from baseline to 9 months were measured with periodontal probe.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03027050
Brief Title
T-PRF Provides Advantages on Periodontal Healing: A Split Mouth Clinical Study
Official Title
T-PRF Contributes to Periodontal Healing
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
November 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ataturk University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis, Periodontal Attachment Loss
Keywords
periodontitis, Growth factors, Periodontal healing
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Titanium-prepared platelet rich fibrine
Arm Type
Experimental
Arm Description
T-PRF was applied with open flap debridement in test group.
Arm Title
Open Flap Debridement alone
Arm Type
Active Comparator
Arm Description
T-PRF was not applied to control groups. Only open flap debridement was applied to control groups.
Intervention Type
Procedure
Intervention Name(s)
T-PRF
Intervention Description
Applied for treatment of periodontal bone loss.
Intervention Type
Procedure
Intervention Name(s)
Open Flap Debridement alone
Primary Outcome Measure Information:
Title
Level of Growth Factor
Description
Change from baseline growth factors levels of GCF at 6 weeks were measured by periopaper
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
relative RANKL/OPG ratio in GCF
Description
Change in relative RANKL/OPG ratio from baseline to 6 weeks were measured by periopaper
Time Frame
6 weeks
Title
Alteration of Clinical Attachment Level
Description
Change from baseline Clinical Attachment Levels at 9 months were measured with periodontal probe.
Time Frame
9 months
Title
Alteration of Periodontal Pocket Depth
Description
Change from baseline Pocket Depth at 9 months were measured with periodontal probe.
Time Frame
9 months
Title
Gingival Margin Level
Description
Change from baseline to 9 months were measured with periodontal probe.
Time Frame
9 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Taner Arabacı
Organizational Affiliation
Ataturk University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
19228091
Citation
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.
Results Reference
background
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T-PRF Provides Advantages on Periodontal Healing: A Split Mouth Clinical Study
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