Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Clinical and Radiological Effect Of Platelet Rich Fibrin on the Healing of Periodontal Intrabony Periodontal Defects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02836314
Recruitment Status : Completed
First Posted : July 19, 2016
Last Update Posted : July 19, 2016
Sponsor:
Collaborator:
Gazi University
Information provided by (Responsible Party):
Yasemin Sezgin, Baskent University

Tracking Information
First Submitted Date  ICMJE July 8, 2016
First Posted Date  ICMJE July 19, 2016
Last Update Posted Date July 19, 2016
Study Start Date  ICMJE January 2011
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 14, 2016)
Clinical attachment level change: The distance from cemento-enamel junction to the depth of the sulcus recorded by a periodontal probe at baseline and 6 months postoperatively [ Time Frame: baseline and 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 14, 2016)
  • Vertical bone loss change: Distance between cemento-enamel junction and base of the defect measured in standardized radiographs at baseline and 6 months postoperatively [ Time Frame: Baseline and 6 months ]
  • Probing depth change: The distance from the gingival margin to the depth of the sulcus recorded by a periodontal probe at baseline and 6 months postoperatively [ Time Frame: baseline and 6 months ]
  • Radiographic defect angle change: Using the function 'angle' the defect angle can be measured by assessing the two lines that represent the root surface of the involved tooth and the bone defect surface at baseline and 6 months postoperatively [ Time Frame: baseline and 6 months ]
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 Clinical and Radiological Effect Of Platelet Rich Fibrin on the Healing of Periodontal Intrabony Periodontal Defects
Official Title  ICMJE Effect Of Platelet Rich Fibrin on the Healing of Periodontal Intrabony Defects Treated With Anorganic Bovine Bone Mineral: A Randomized Clinical and Radiological Study
Brief Summary The aim of this split mouth, single-center, controlled study is to compare the healing of intrabony defects treated with a combination of Anorganic Bovine Bone Mineral (ABBM)/Platelet Rich Fibrin (PRF) or Anorganic Bovine Bone Mineral alone. The hypothesis being tested in the study was that PRF would augment the regenerative effects of ABBM in human intrabony defects.
Detailed Description Anorganic bovine bone mineral (ABBM) is extensively used in the treatment of intrabony defects. Platelet rich fibrin (PRF) is a new generation platelet concentrate with a simplified technique. Although there are some studies on the use of PRF in the treatment of intrabony defects, to date none of them evaluate its additive effects with ABBM. Therefore, a randomized, split mouth clinical trial was conducted to compare the healing of intrabony defects treated with a PRF/ABBM combination and to those obtained with ABBM alone. Using a split mouth design, 15 paired intrabony defects were randomly treated with either ABBM alone (control group) or with ABBM- PRF combination (test group). The following clinical parameters and radiographic measurements were recorded at baseline and six months postoperatively: plaque index (PI), gingival index (GI), probing depth (PD), gingival recession (GR), clinical attachment level (CAL), vertical bone loss, the depth of the defect and defect angle
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Periodontitis
  • Intrabony Periodontal Defect
Intervention  ICMJE
  • Other: Anorganic Bovine Bone Mineral (ABBM)
    In the control group, periodontal intrabony defects were treated with ABBM alone.
  • Other: Anorganic Bovine Bone Mineral and Platelet Rich Fibrin (PRF)
    In the test group, periodontal intrabony defects were treated with ABBM and PRF combination.
Study Arms  ICMJE
  • Experimental: PRF and ABBM
    Intervention: Anorganic Bovine Bone Mineral and Platelet Rich fibrin is applied to the periodontal intrabony defects
    Intervention: Other: Anorganic Bovine Bone Mineral and Platelet Rich Fibrin (PRF)
  • Active Comparator: Anorganic Bovine Bone Mineral
    Intervention: Anorganic Bovine Bone Mineral is applied to the periodontal intrabony defects
    Intervention: Other: Anorganic Bovine Bone Mineral (ABBM)
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 Completed
Actual Enrollment  ICMJE
 (submitted: July 14, 2016)
15
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • no systemic diseases;
  • a good level of oral hygiene (OH) (plaque index<0.15);
  • presence of two paired two-wall or three-wall intrabony defects with probing depth ≥6mm and an intrabony component ≥3mm as detected on radiographs; -no intrabony defects extending into the furcation area;
  • tooth mobility ≤1;
  • tooth and adjoining teeth testing vital and without symptoms or signs of endodontic involvement;
  • tooth and adjoining teeth free of caries or inadequate restorations.

Exclusion Criteria:

  • patients with compromised immune systems;
  • pregnant and/or lactating women;
  • patients taking any drug known to affect the periodontal status or affect the coagulation system
  • smokers.
Sex/Gender  ICMJE Not Provided
Ages  ICMJE 38 Years to 61 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02836314
Other Study ID Numbers  ICMJE 03/10-12
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Yasemin Sezgin, Baskent University
Study Sponsor  ICMJE Baskent University
Collaborators  ICMJE Gazi University
Investigators  ICMJE
Study Director: Levent Taner, PhD, DDS Gazi University, Faculty of Dentistry, Department of Periodontology
PRS Account Baskent University
Verification Date July 2016

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