Titanium-prepared Platelet-rich Fibrin in Periodontal Regeneration

• Sponsor: Ataturk University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05409495
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Actual Duration (Months): 10.5
• Patients Per Site Per Month: 1.9

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Platelet-Rich Fibrin	Procedure: periodontal surgical procedure (open flap debridement); Procedure: periodontal surgical procedure (OFD +autogenous Titanium-prepared platelet-rich fibrin (OFD+ T-PRF))	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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.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)
• Primary Purpose: Treatment
• Official Title: The Effect of Titanium- Platelet Rich Fibrin in Periodontal Intrabony Defects: A Randomized Controlled Split-Mouth Clinical Study
• Actual Study Start Date: Apr 1, 2021
• Actual Primary Completion Date: Feb 1, 2022
• Actual Study Completion Date: Feb 15, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Clinical findings; Intraoral periodontal measurements were made to evaluate the patient's periodontal tissue healing. [9 month]

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

2. Clinical findings; Intraoral periodontal measurements were made to evaluate the patient's periodontal tissue healing. [9 month]

   modified sulcus bleeding index (mSBI)

3. Clinical findings; Intraoral periodontal measurements were made to evaluate the patient's periodontal tissue healing. [9 month]

   probing depth from the gingival margin (PD) (evaluated from the gingival margin to the base of the pocket)

4. Clinical findings; Intraoral periodontal measurements were made to evaluate the patient's periodontal tissue healing. [9 month]

   gingival marginal level (GML) (measured from the apical most end of the stent to the crest of the gingival margin)

5. Clinical findings; Intraoral periodontal measurements were made to evaluate the patient's periodontal tissue healing. [9 month]

   relative attachment level (RAL) (evaluated from the cementoenamel junction to the base of the pocket and gingival marginal level)

Secondary Outcome Measures

1. Gingival Crevicular Fluid Collection; The gingival crevicular fluid (GCF) sample was collected to biochemically evaluate the patient's periodontal tissue healing. [12 weeks]

   fibroblast growth factors (FGF-2)

2. Gingival Crevicular Fluid Collection; The gingival crevicular fluid (GCF) sample was collected to biochemically evaluate the patient's periodontal tissue healing. [12 weeks]

   platelet-derived growth factors (PDGF-BB)

3. 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))

Other Outcome Measures

1. Radiographic Measurements; Measurements were made on radiographic images in order to evaluate the healing of the patient's bone tissue. [9 month]

   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.

2. 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Atatürk University Faculty of Dentistry Department of Peirodontology	Erzurum		Turkey	25240

Sponsors and Collaborators

• Ataturk University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gurbet Alev OZTAS SAHINER, Principal Investigator, Ataturk University
• ClinicalTrials.gov Identifier: NCT05409495
• Other Study ID Numbers: B.30.2.ATA.0.01.00/93
• First Posted: Jun 8, 2022
• Last Update Posted: Jun 8, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Gurbet Alev OZTAS SAHINER, Principal Investigator, Ataturk University: chronic periodontitis; growth factors; guided tissue regeneration; periodontal; platelet-derived growth factor; platelet-rich fibrin

Study Results

No Results Posted as of Jun 8, 2022