Titanium-prepared Platelet-rich Fibrin in Periodontal Regeneration

January 8, 2024 updated by: Gurbet Alev OZTAS SAHINER, Ataturk University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Erzurum, Turkey, 25240
        • Atatürk University Faculty of Dentistry Department of Peirodontology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: The control group treated with open flap debridement (OFD)
The control group periodontal intrabony defects were treated with open flap debridement (OFD) only.
Procedure: periodontal surgical procedure (open flap debridement)
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.
Experimental: The test group treated with 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.
Procedure: periodontal surgical procedure (OFD +autogenous Titanium-prepared platelet-rich fibrin (OFD+ T-PRF))
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
site-specific plaque index (PI) (Silness & Loe)
Time Frame: 9 month
measurement of plaque accumulated on the tooth surface
9 month
modified sulcus bleeding index (mSBI)
Time Frame: 9 month
assessment of bleeding gums
9 month
probing depth from the gingival margin (PD)
Time Frame: 9 month
evaluated from the gingival margin to the base of the pocket
9 month
gingival marginal level (GML)
Time Frame: 9 month
measured from the apical most end of the stent to the crest of the gingival margin
9 month
relative attachment level (RAL)
Time Frame: 9 month
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.
Time Frame: 12 weeks
relative ratio of receptor activator nuclear factor kappa-B (RANKL)/osteoprotegerin (OPG))
12 weeks
fibroblast growth factors (FGF-2)
Time Frame: 12 weeks
growth factor affecting periodontal regeneration
12 weeks
platelet-derived growth factors (PDGF-BB)
Time Frame: 12 weeks
growth factor affecting periodontal regeneration
12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
While examining the radiographic intraosseous defect, the distance between the alveolar bone crest and the base of the defect was taken into account. This distance (IBD) was evaluated using computer aided software.
Time Frame: 9 month
Radiographic Measurements; Measurements were made on radiographic images in order to evaluate the healing of the patient's bone tissue.
9 month
Also while measuring periodontal bone support (PBS) using radiographic images used Image Tool v.3.0 (UTHSCSA).
Time Frame: 9 month
Radiographic Measurements; Measurements were made on radiographic images in order to evaluate the healing of the patient's bone tissue.
9 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ataturk University

Investigators

  • Study Director: Didem Ozkal Eminoglu, Dr, Atatürk University Faculty of Dentistry Department of Periodontology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2021

Primary Completion (Actual)

February 1, 2022

Study Completion (Actual)

February 15, 2022

Study Registration Dates

First Submitted

May 17, 2022

First Submitted That Met QC Criteria

June 4, 2022

First Posted (Actual)

June 8, 2022

Study Record Updates

Last Update Posted (Actual)

January 10, 2024

Last Update Submitted That Met QC Criteria

January 8, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • B.30.2.ATA.0.01.00/93

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

If the data of the study is requested by other researchers, the study supervisor can be contacted.

IPD Sharing Time Frame

There is no specific time restriction for this.

IPD Sharing Access Criteria

There is no specific time criterion for this.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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