Titanium-prepared Platelet-rich Fibrin in Periodontal Regeneration

Study Overview
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Brief Summary
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The aim of this split-mouth, randomized, and controlled study was to compare open flap debridement (OFD) alone against OFD with autogenous Titanium-prepared platelet-rich fibrin (OFD+ T-PRF) combined in treating intrabony defects (IBD). Subjects were 20 systemically healthy patients with chronic periodontitis according to 2017 World Workshop. Bilateral operation sites in patients (40 sites) were randomly selected for OFD alone or OFD+ T-PRF combined. Clinical parameters (probing depth (PD), relative attachment level (RAL), and gingival marginal level(GML)), radiographic parameters (intrabone defects (IBDs) and periodontal bone support (PBS)), and growth factors levels (GFL) in gingival crevicular fluid (GCF) (platelet-derived growth factors (PDGF-BB), fibroblast growth factors (FGF-2), relative ratio of receptor activator nuclear factor kappa-B (RANKL)/osteoprotegerin (OPG)) were analyzed. The Wilcoxon signed-rank test, the Student's t-test, the two way ANOVA, and the Tukey post hoc test were used for statistical analysis.

Official Title
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The Effect of Titanium- Platelet Rich Fibrin in Periodontal Intrabony Defects: A Randomized Controlled Split-Mouth Clinical Study

Conditions
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Platelet-Rich Fibrin

Intervention / Treatment
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* Procedure: periodontal surgical procedure (open flap debridement)
* Procedure: periodontal surgical procedure (OFD +autogenous Titanium-prepared platelet-rich fibrin (OFD+ T-PRF))


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1)Patients with bilaterally similar periodontal intrabone defects (IBDs) Exclusion Criteria: Who did not show the necessary oral hygiene during the non-surgical periodontal treatment process, history of periodontal therapy in the preceding 1 year, presence of devital tooth, Grade II, or higher mobility of the tooth, and less than 3 bone walls or a defect in the furcation at the site of the bone defect, history of any systemic diseases that can alter the course of the periodontal disease, smokers, use of antibiotics, pregnant/lactating women.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two different treatment modalities to treat deep periodontal intrabony defects were compared in this split-mouth, randomized, parallel and clinical study. The control group defects were treated with OFD only while the test group defects were treated with OFD supplemented with T-PRF. The same periodontal treatment procedure was applied in both groups, except for the use of T-PRF. Clinical and radiographic parameters were measured from baseline to 9 months after surgery.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The control group treated with open flap debridement (OFD)<br>The control group periodontal intrabony defects were treated with open flap debridement (OFD) only. | Procedure: periodontal surgical procedure (open flap debridement)<br>* All surgical procedures were performed by the second periodontist. 0.12% Chlorhexidine digluconate (CHX) rinse for intraoral antisepsis and a povidone iodine solution was used for extraoral antisepsis. After local anesthesia (2% lidocaine with epinephrine 1:100,000/ Astra, Westbrough, MA) was applied, the full thickness trapezoidal flap was raised large enough to provide adequate view of the defect area. Subgingival debridement and root planning were performed with the use of area-specific curets (Gracey curets, Hu-Friedy), and granulation tissue was removed The IBD area in the control group was closed without applying any material. Then mucoperiosteal flaps were repositioned with sutured with 4/0 monoprolene sutures.<br>|
| Experimental: The test group treated with OFD +autogenous Titanium-prepared platelet-rich fibrin (OFD+ T-PRF)<br>The test group periodontal intrabony defects were treated with open flap debridement (OFD) with autogenous Titanium-prepared platelet-rich fibrin (OFD+ T-PRF) combined. | Procedure: periodontal surgical procedure (OFD +autogenous Titanium-prepared platelet-rich fibrin (OFD+ T-PRF))<br>* All surgical procedures were performed by the second periodontist. 0.12% Chlorhexidine digluconate (CHX) rinse for intraoral antisepsis and a povidone iodine solution was used for extraoral antisepsis. After local anesthesia (2% lidocaine with epinephrine 1:100,000/ Astra, Westbrough, MA) was applied, the full thickness trapezoidal flap was raised large enough to provide adequate view of the defect area. Subgingival debridement and root planning were performed with the use of area-specific curets (Gracey curets, Hu-Friedy), and granulation tissue was removed (Figure 2a). The blood supply of the defect areas was taken into account. At the test site, IBDs were filled with T-PRF and T-PRF membranes were adapted over the defects both buccally and lingually, in addition to OFD (Figure 2b). Then mucoperiosteal flaps were repositioned with sutured with 4/0 monoprolene sutures.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical findings; Intraoral periodontal measurements were made to evaluate the patient's periodontal tissue healing. | site-specific plaque index (PI) (Silness & Loe) | 9 month | 
| Clinical findings; Intraoral periodontal measurements were made to evaluate the patient's periodontal tissue healing. | modified sulcus bleeding index (mSBI) | 9 month | 
| Clinical findings; Intraoral periodontal measurements were made to evaluate the patient's periodontal tissue healing. | probing depth from the gingival margin (PD) (evaluated from the gingival margin to the base of the pocket) | 9 month | 
| Clinical findings; Intraoral periodontal measurements were made to evaluate the patient's periodontal tissue healing. | gingival marginal level (GML) (measured from the apical most end of the stent to the crest of the gingival margin) | 9 month | 
| Clinical findings; Intraoral periodontal measurements were made to evaluate the patient's periodontal tissue healing. | relative attachment level (RAL) (evaluated from the cementoenamel junction to the base of the pocket and gingival marginal level) | 9 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gingival Crevicular Fluid Collection; The gingival crevicular fluid (GCF) sample was collected to biochemically evaluate the patient's periodontal tissue healing. | fibroblast growth factors (FGF-2) | 12 weeks | 
| Gingival Crevicular Fluid Collection; The gingival crevicular fluid (GCF) sample was collected to biochemically evaluate the patient's periodontal tissue healing. | platelet-derived growth factors (PDGF-BB) | 12 weeks | 
| Gingival Crevicular Fluid Collection; The gingival crevicular fluid (GCF) sample was collected to biochemically evaluate the patient's periodontal tissue healing. | relative ratio of receptor activator nuclear factor kappa-B (RANKL)/osteoprotegerin (OPG)) | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic periodontitis, growth factors, guided tissue regeneration, periodontal, platelet-derived growth factor, platelet-rich fibrin