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Completed

NCT Number: NCT05409495

Titanium-prepared Platelet-rich Fibrin in Periodontal Regeneration

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.

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Key information

Conditions

Platelet-rich Fibrin Chronic Disease Chronic Periodontitis Disease Attributes Mouth Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atatürk University Faculty of Dentistry Department of Peirodontology

Erzurum, 25240, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

periodontal surgical procedure (open flap debridement)

Procedure

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.

periodontal surgical procedure (OFD +autogenous Titanium-prepared platelet-rich fibrin (OFD+ T-PRF))

Procedure

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.

Primary outcomes

  1. site-specific plaque index (PI) (Silness & Loe)

    Time frame: 9 month

    measurement of plaque accumulated on the tooth surface

  2. modified sulcus bleeding index (mSBI)

    Time frame: 9 month

    assessment of bleeding gums

  3. probing depth from the gingival margin (PD)

    Time frame: 9 month

    evaluated from the gingival margin to the base of the pocket

  4. gingival marginal level (GML)

    Time frame: 9 month

    measured from the apical most end of the stent to the crest of the gingival margin

  5. relative attachment level (RAL)

    Time frame: 9 month

    evaluated from the cementoenamel junction to the base of the pocket and gingival marginal level

Secondary outcomes

  1. fibroblast growth factors (FGF-2)

    Time frame: 12 weeks

    growth factor affecting periodontal regeneration

  2. platelet-derived growth factors (PDGF-BB)

    Time frame: 12 weeks

    growth factor affecting periodontal regeneration

  3. 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))

Other outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 8, 2022
Registry last updated
Jan 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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