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

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ClinicalTrials.gov Identifier: NCT02810548
Recruitment Status : Unknown
Verified June 2016 by Maha A. Bahammam, King Abdulaziz University.
Recruitment status was:  Not yet recruiting
First Posted : June 23, 2016
Last Update Posted : June 23, 2016
Sponsor:
Information provided by (Responsible Party):
Maha A. Bahammam, King Abdulaziz University

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.


Condition or disease Intervention/treatment Phase
Bony Defects Procedure: OFD alone Drug: Platelet rich Fibrin Drug: Nanohydroxyapatite Early Phase 1

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  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical and Biochemical Evaluation of Platelets Rich Fibrin (PRF) and Nanohydroxyapatite in the Treatment of Intrabony Defects
Study Start Date : August 2016
Estimated Primary Completion Date : December 2016

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 Name: 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 Name: Periodontal Surgery

Drug: Platelet rich Fibrin
Natural platelet concentrate rich in growth factors
Other Name: 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 Name: Periodontal Surgery

Drug: Nanohydroxyapatite
Synthetic bone graft
Other Name: 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 Name: Periodontal Surgery

Drug: Platelet rich Fibrin
Natural platelet concentrate rich in growth factors
Other Name: Natural growth factor

Drug: Nanohydroxyapatite
Synthetic bone graft
Other Name: Bone graft




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Changes in Gingival index [ Time Frame: up to 3 months ]
    Gingival index (GI) developed on 1963.

  2. Changes in level of attachment loss [ Time Frame: up to 3 months ]
    Attachment loss: will be measured from the cemento-enamel junction (CEJ) to the apical part of the sulcus.

  3. Changes in probing pocket depth [ Time Frame: up to 3 months ]
    Probing pocket depth (PD): six measurements per tooth will be recorded by using the University of Michigan O periodontal probe with Williams markings.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02810548


Contacts
Contact: Maha A Bahamas, DSc +966505303227 mbahammam@kau.edu.sa

Locations
Saudi Arabia
King Abdelaziz University. Faculty of dentistry Not yet recruiting
Jeddah, Saudi Arabia, 21589
Contact: Maha A Bahammam, DSc    +966505303227    mbahammam@kau.edu.sa   
Sponsors and Collaborators
King Abdulaziz University
Investigators
Principal Investigator: Maha A Bahammam, DSc King Abdelaziz University

Responsible Party: Maha A. Bahammam, Associate Professor and Consultant of Periodontology, King Abdulaziz University
ClinicalTrials.gov Identifier: NCT02810548     History of Changes
Other Study ID Numbers: 032-16
First Posted: June 23, 2016    Key Record Dates
Last Update Posted: June 23, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Mitogens
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action