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

Early Phase 1CompletedNCT02810548

King Abdulaziz University60 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Bony Defects

Interventions

OFD alonePROCEDURE

Periodontal surgical cleaning procedure

Platelet rich FibrinDRUG

Natural platelet concentrate rich in growth factors

NanohydroxyapatiteDRUG

Synthetic bone graft

Eligibility

Sex: ALLMin age: 20 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

King Abdelaziz University. Faculty of dentistry

Jeddah, Saudi Arabia

Outcomes

Primary Outcomes

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.

Time frame: up to 3 weeks.

Secondary Outcomes

Changes in Gingival index

Gingival index (GI) developed on 1963.

Time frame: 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.

Time frame: 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.

Time frame: up to 3 months

Data from ClinicalTrials.gov

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