Evaluation of Platelets Rich Fibrin and Nanohydroxyapatite in the Treatment of Intrabony Defects

Clinical and Biochemical Evaluation of Platelets Rich Fibrin (PRF) and Nanohydroxyapatite in the Treatment of Intrabony Defects

Background: the ultimate goal of periodontal therapy is the regeneration of periodontal tissues. Researches had demonstrated the benefits of platelet concentrates bine grafts in osseous regeneration in the areas of periodontal surgery.

Aim of the study: to evaluate the effect of PRF with/without nanohydroxyapatite in periodontal intrabony defects.

Study Overview

• Status: Completed
• Conditions: Bony Defects
• Intervention / Treatment: Procedure: OFD alone; Drug: Platelet rich Fibrin; Drug: Nanohydroxyapatite

Detailed Description

Background: the ultimate goal of periodontal therapy is the regeneration of periodontal tissues. The regenerative and wound healing potential of platelets has attracted much attention over the last few years. Researches had demonstrated the benefits of platelet concentrates in osseous regeneration in the areas of periodontal surgery and implantology. In addition, nanohydroxyapatite was shown to be unsheathed by newly formed bone and partly replaced by it, but resorbed very slowly, as shown in animal experiments after 9 months or in clinical studies after a 6-month observation period. The clinical and biochemical studies evaluating the regenerative effect of PRF alone or in combination with nanohydroxyapatite in periodontal intrabony defects are still deficient.

Aim of the study: to evaluate clinical and biochemical effect of PRF with/without nanohydroxyapatite in treatment of human intrabony defects.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Saudi Arabia
  • Jeddah, Saudi Arabia, 21589
    • King Abdelaziz University. Faculty of dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• All patients are free from systemic illness.
• All patients should be diagnosed as having chronic periodontitis.
• Patients should be cooperative, motivated and willing to follow our treatment protocol and follow up visits.
• Patients selected had not received antibiotics or anti-inflammatory therapy in the 6 months prior to examination.

Exclusion Criteria:

• Presence of areas of periodontal pocket of (probing depth ≥5 and clinical attachment level (CAL) ≥ 3).
• Patients who have received any type of periodontal treatment in the past 6 months prior to examination.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: OFD alone; Control group: including 15 defects that will receive open flap debridement (OFD).	Procedure: OFD alone; Periodontal surgical cleaning procedure; Other Names: Periodontal Surgery
Active Comparator: PRF + OFD; Test group (1): including 15 defects that will receive platelet rich fibrin (PRF) with open flap debridement (OFD).	Procedure: OFD alone; Periodontal surgical cleaning procedure; Other Names: Periodontal Surgery; Drug: Platelet rich Fibrin; Natural platelet concentrate rich in growth factors; Other Names: Natural growth factor
Active Comparator: Bone + OFD; Test group (2): including 15 defects that will receive nanohydroxyapatite bone graft with open flap debridement OFD).	Procedure: OFD alone; Periodontal surgical cleaning procedure; Other Names: Periodontal Surgery; Drug: Nanohydroxyapatite; Synthetic bone graft; Other Names: Bone graft
Active Comparator: PRF + Bone + OFD; Test group (3): including 15 defects that will receive nanohydroxyapatite bone graft with platelet rich fibrin (PRF) after open flap debridement (OFD).	Procedure: OFD alone; Periodontal surgical cleaning procedure; Other Names: Periodontal Surgery; Drug: Platelet rich Fibrin; Natural platelet concentrate rich in growth factors; Other Names: Natural growth factor; Drug: Nanohydroxyapatite; Synthetic bone graft; Other Names: Bone graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Gingival crevicular fluid (GCF)	GCF will be collected after removing saliva and supra-gingival plaque using methylcellulose filter paper strip that will be inserted in the periodontal pocket and will be let in for 30 seconds.	up to 3 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Gingival index	Gingival index (GI) developed on 1963.	up to 3 months
Changes in level of attachment loss	Attachment loss: will be measured from the cemento-enamel junction (CEJ) to the apical part of the sulcus.	up to 3 months
Changes in probing pocket depth	Probing pocket depth (PD): six measurements per tooth will be recorded by using the University of Michigan O periodontal probe with Williams markings.	up to 3 months

Collaborators and Investigators

• Sponsor: King Abdulaziz University
• Investigators: Principal Investigator: Maha A Bahammam, DSc, King Abdelaziz University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2015
• Primary Completion (Actual): November 15, 2016
• Study Completion (Actual): November 30, 2016

Study Registration Dates

• First Submitted: June 8, 2016
• First Submitted That Met QC Criteria: June 20, 2016
• First Posted (Estimated): June 23, 2016

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Mitosis Modulators; Mitogens
• Other Study ID Numbers: 032-16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO