Clinical and Radiological Effect Of Platelet Rich Fibrin on the Healing of Periodontal Intrabony Periodontal Defects

Effect Of Platelet Rich Fibrin on the Healing of Periodontal Intrabony Defects Treated With Anorganic Bovine Bone Mineral: A Randomized Clinical and Radiological Study

The aim of this split mouth, single-center, controlled study is to compare the healing of intrabony defects treated with a combination of Anorganic Bovine Bone Mineral (ABBM)/Platelet Rich Fibrin (PRF) or Anorganic Bovine Bone Mineral alone. The hypothesis being tested in the study was that PRF would augment the regenerative effects of ABBM in human intrabony defects.

Study Overview

• Status: Completed
• Conditions: Chronic Periodontitis; Intrabony Periodontal Defect
• Intervention / Treatment: Other: Anorganic Bovine Bone Mineral and Platelet Rich Fibrin (PRF); Other: Anorganic Bovine Bone Mineral (ABBM)

Detailed Description

Anorganic bovine bone mineral (ABBM) is extensively used in the treatment of intrabony defects. Platelet rich fibrin (PRF) is a new generation platelet concentrate with a simplified technique. Although there are some studies on the use of PRF in the treatment of intrabony defects, to date none of them evaluate its additive effects with ABBM. Therefore, a randomized, split mouth clinical trial was conducted to compare the healing of intrabony defects treated with a PRF/ABBM combination and to those obtained with ABBM alone. Using a split mouth design, 15 paired intrabony defects were randomly treated with either ABBM alone (control group) or with ABBM- PRF combination (test group). The following clinical parameters and radiographic measurements were recorded at baseline and six months postoperatively: plaque index (PI), gingival index (GI), probing depth (PD), gingival recession (GR), clinical attachment level (CAL), vertical bone loss, the depth of the defect and defect angle

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06540
    • Yasemin Sezgin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years to 61 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• no systemic diseases;
• a good level of oral hygiene (OH) (plaque index<0.15);
• presence of two paired two-wall or three-wall intrabony defects with probing depth ≥6mm and an intrabony component ≥3mm as detected on radiographs; -no intrabony defects extending into the furcation area;
• tooth mobility ≤1;
• tooth and adjoining teeth testing vital and without symptoms or signs of endodontic involvement;
• tooth and adjoining teeth free of caries or inadequate restorations.

Exclusion Criteria:

• patients with compromised immune systems;
• pregnant and/or lactating women;
• patients taking any drug known to affect the periodontal status or affect the coagulation system
• smokers.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PRF and ABBM; Intervention: Anorganic Bovine Bone Mineral and Platelet Rich fibrin is applied to the periodontal intrabony defects	Other: Anorganic Bovine Bone Mineral and Platelet Rich Fibrin (PRF); In the test group, periodontal intrabony defects were treated with ABBM and PRF combination.
Active Comparator: Anorganic Bovine Bone Mineral; Intervention: Anorganic Bovine Bone Mineral is applied to the periodontal intrabony defects	Other: Anorganic Bovine Bone Mineral (ABBM); In the control group, periodontal intrabony defects were treated with ABBM alone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Clinical attachment level change: The distance from cemento-enamel junction to the depth of the sulcus recorded by a periodontal probe at baseline and 6 months postoperatively	baseline and 6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Vertical bone loss change: Distance between cemento-enamel junction and base of the defect measured in standardized radiographs at baseline and 6 months postoperatively	Baseline and 6 months
Probing depth change: The distance from the gingival margin to the depth of the sulcus recorded by a periodontal probe at baseline and 6 months postoperatively	baseline and 6 months
Radiographic defect angle change: Using the function 'angle' the defect angle can be measured by assessing the two lines that represent the root surface of the involved tooth and the bone defect surface at baseline and 6 months postoperatively	baseline and 6 months

Collaborators and Investigators

• Sponsor: Baskent University
• Collaborators: Gazi University
• Investigators: Study Director: Levent Taner, PhD, DDS, Gazi University, Faculty of Dentistry, Department of Periodontology

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: July 8, 2016
• First Submitted That Met QC Criteria: July 14, 2016
• First Posted (Estimate): July 19, 2016

Study Record Updates

• Last Update Posted (Estimate): July 19, 2016
• Last Update Submitted That Met QC Criteria: July 14, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: platelet rich fibrin; Graft; Anorganic bovine bone mineral;; Intrabony periodontal defect
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Chronic Periodontitis
• Other Study ID Numbers: 03/10-12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes