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Clinical Trials/NCT02810548
NCT02810548
Completed
Early Phase 1

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

King Abdulaziz University1 site in 1 country60 target enrollmentFebruary 1, 2015

Overview

Phase
Early Phase 1
Intervention
OFD alone
Conditions
Bony Defects
Sponsor
King Abdulaziz University
Enrollment
60
Locations
1
Primary Endpoint
Changes in Gingival crevicular fluid (GCF)
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2015
End Date
November 30, 2016
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Maha A. Bahammam

Associate Professor and Consultant of Periodontology

King Abdulaziz University

Eligibility Criteria

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.

Arms & Interventions

OFD alone

Control group: including 15 defects that will receive open flap debridement (OFD).

Intervention: OFD alone

PRF + OFD

Test group (1): including 15 defects that will receive platelet rich fibrin (PRF) with open flap debridement (OFD).

Intervention: OFD alone

PRF + OFD

Test group (1): including 15 defects that will receive platelet rich fibrin (PRF) with open flap debridement (OFD).

Intervention: Platelet rich Fibrin

Bone + OFD

Test group (2): including 15 defects that will receive nanohydroxyapatite bone graft with open flap debridement OFD).

Intervention: OFD alone

Bone + OFD

Test group (2): including 15 defects that will receive nanohydroxyapatite bone graft with open flap debridement OFD).

Intervention: Nanohydroxyapatite

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).

Intervention: OFD alone

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).

Intervention: Platelet rich Fibrin

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).

Intervention: Nanohydroxyapatite

Outcomes

Primary Outcomes

Changes in Gingival crevicular fluid (GCF)

Time Frame: up to 3 weeks.

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.

Secondary Outcomes

  • Changes in Gingival index(up to 3 months)
  • Changes in level of attachment loss(up to 3 months)
  • Changes in probing pocket depth(up to 3 months)

Study Sites (1)

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