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Titanium-prepared Platelet-rich Fibrin in Periodontal Regeneration

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05409495
Enrollment
20
Registered
2022-06-08
Start date
2021-04-01
Completion date
2022-02-15
Last updated
2024-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Platelet-Rich Fibrin

Keywords

chronic periodontitis, growth factors, guided tissue regeneration, periodontal, platelet-derived growth factor, platelet-rich fibrin

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.

Interventions

PROCEDUREperiodontal 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.

PROCEDUREperiodontal 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.

Sponsors

Ataturk University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
relative attachment level (RAL)9 monthevaluated from the cementoenamel junction to the base of the pocket and gingival marginal level
site-specific plaque index (PI) (Silness & Loe)9 monthmeasurement of plaque accumulated on the tooth surface
modified sulcus bleeding index (mSBI)9 monthassessment of bleeding gums
probing depth from the gingival margin (PD)9 monthevaluated from the gingival margin to the base of the pocket
gingival marginal level (GML)9 monthmeasured from the apical most end of the stent to the crest of the gingival margin

Secondary

MeasureTime frameDescription
fibroblast growth factors (FGF-2)12 weeksgrowth factor affecting periodontal regeneration
platelet-derived growth factors (PDGF-BB)12 weeksgrowth 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 weeksrelative ratio of receptor activator nuclear factor kappa-B (RANKL)/osteoprotegerin (OPG))

Other

MeasureTime frameDescription
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.9 monthRadiographic Measurements; Measurements were made on radiographic images in order to evaluate the healing of the patient's bone tissue.
Also while measuring periodontal bone support (PBS) using radiographic images used Image Tool v.3.0 (UTHSCSA).9 monthRadiographic Measurements; Measurements were made on radiographic images in order to evaluate the healing of the patient's bone tissue.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026