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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

Tracking Information
First Submitted Date  ICMJE June 8, 2016
First Posted Date  ICMJE June 23, 2016
Last Update Posted Date June 23, 2016
Study Start Date  ICMJE August 2016
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 20, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 20, 2016)
  • Changes in Gingival index [ Time Frame: up to 3 months ]
    Gingival index (GI) developed on 1963.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Platelets Rich Fibrin and Nanohydroxyapatite in the Treatment of Intrabony Defects
Official Title  ICMJE Clinical and Biochemical Evaluation of Platelets Rich Fibrin (PRF) and Nanohydroxyapatite in the Treatment of Intrabony Defects
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Bony Defects
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Placebo Comparator: OFD alone
    Control group: including 15 defects that will receive open flap debridement (OFD).
    Intervention: Procedure: OFD alone
  • Active Comparator: PRF + OFD
    Test group (1): including 15 defects that will receive platelet rich fibrin (PRF) with open flap debridement (OFD).
    Interventions:
    • Procedure: OFD alone
    • Drug: Platelet rich Fibrin
  • Active Comparator: Bone + OFD
    Test group (2): including 15 defects that will receive nanohydroxyapatite bone graft with open flap debridement OFD).
    Interventions:
    • Procedure: OFD alone
    • Drug: Nanohydroxyapatite
  • 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).
    Interventions:
    • Procedure: OFD alone
    • Drug: Platelet rich Fibrin
    • Drug: Nanohydroxyapatite
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 20, 2016)
60
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Saudi Arabia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02810548
Other Study ID Numbers  ICMJE 032-16
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Maha A. Bahammam, King Abdulaziz University
Study Sponsor  ICMJE King Abdulaziz University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Maha A Bahammam, DSc King Abdelaziz University
PRS Account King Abdulaziz University
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP