Titanium-prepared Platelet-rich Fibrin in Periodontal Regeneration

Not Applicable

Completed

• Conditions: Platelet-Rich Fibrin
• Interventions: Procedure: periodontal surgical procedure (open flap debridement); Procedure: periodontal surgical procedure (OFD +autogenous Titanium-prepared platelet-rich fibrin (OFD+ T-PRF))

• Registration Number: NCT05409495
• Lead Sponsor: Ataturk University

Brief Summary

In this study, the possible effect of blood group distribution on the content of blood biomaterial was investigated. 64 volunteers were included in the study. Various parameters were evaluated. As a result, it was concluded that blood group distribution does not affect blood biomaterial content.

Detailed Description

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.

Study Timeline

• Study Start: 2021-04-01
• Primary Completion: 2022-02-01
• Study Completion: 2022-02-15
• Study First Submitted: 2022-05-17
• Study First Submitted QC: 2022-06-04
• Study First Posted: 2022-06-08
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-08
• Last Update Posted: 2024-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1)Patients with bilaterally similar periodontal intrabone defects (IBDs)

Exclusion Criteria

1. Who did not show the necessary oral hygiene during the non-surgical periodontal treatment process,
2. history of periodontal therapy in the preceding 1 year,
3. 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,
4. history of any systemic diseases that can alter the course of the periodontal disease,
5. smokers,
6. use of antibiotics,
7. pregnant/lactating women.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The control group treated with open flap debridement (OFD)	periodontal surgical procedure (open flap debridement)	The control group periodontal intrabony defects were treated with open flap debridement (OFD) only.
The test group treated with OFD +autogenous Titanium-prepared platelet-rich fibrin (OFD+ T-PRF)	periodontal surgical procedure (OFD +autogenous Titanium-prepared platelet-rich fibrin (OFD+ T-PRF))	The test group periodontal intrabony defects were treated with open flap debridement (OFD) with autogenous Titanium-prepared platelet-rich fibrin (OFD+ T-PRF) combined.

Primary Outcome Measures

Name	Time	Method
site-specific plaque index (PI) (Silness & Loe)	9 month	measurement of plaque accumulated on the tooth surface
modified sulcus bleeding index (mSBI)	9 month	assessment of bleeding gums
probing depth from the gingival margin (PD)	9 month	evaluated from the gingival margin to the base of the pocket
gingival marginal level (GML)	9 month	measured from the apical most end of the stent to the crest of the gingival margin
relative attachment level (RAL)	9 month	evaluated from the cementoenamel junction to the base of the pocket and gingival marginal level

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Atatürk University Faculty of Dentistry Department of Peirodontology; 🇹🇷 Erzurum, Turkey