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

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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

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.

Condition or disease Intervention/treatment Phase
Chronic Periodontitis Intrabony Periodontal Defect Other: Anorganic Bovine Bone Mineral (ABBM) Other: Anorganic Bovine Bone Mineral and Platelet Rich Fibrin (PRF) Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect Of Platelet Rich Fibrin on the Healing of Periodontal Intrabony Defects Treated With Anorganic Bovine Bone Mineral: A Randomized Clinical and Radiological Study
Study Start Date : January 2011
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Minerals

Arm Intervention/treatment
Experimental: PRF and ABBM
Intervention: Anorganic Bovine Bone Mineral and Platelet Rich fibrin is applied to the periodontal intrabony defects
Other: Anorganic Bovine Bone Mineral and Platelet Rich Fibrin (PRF)
In the test group, periodontal intrabony defects were treated with ABBM and PRF combination.

Active Comparator: Anorganic Bovine Bone Mineral
Intervention: Anorganic Bovine Bone Mineral is applied to the periodontal intrabony defects
Other: Anorganic Bovine Bone Mineral (ABBM)
In the control group, periodontal intrabony defects were treated with ABBM alone.




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]


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Ages Eligible for Study:   38 Years to 61 Years   (Adult)
Accepts Healthy Volunteers:   Yes
Criteria

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.

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): NCT02836314


Locations
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Turkey
Yasemin Sezgin
Ankara, Turkey, 06540
Sponsors and Collaborators
Baskent University
Gazi University
Investigators
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Study Director: Levent Taner, PhD, DDS Gazi University, Faculty of Dentistry, Department of Periodontology
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Responsible Party: Yasemin Sezgin, Dr, Baskent University
ClinicalTrials.gov Identifier: NCT02836314    
Other Study ID Numbers: 03/10-12
First Posted: July 19, 2016    Key Record Dates
Last Update Posted: July 19, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Yasemin Sezgin, Baskent University:
Anorganic bovine bone mineral;
Graft
Intrabony periodontal defect
platelet rich fibrin
Additional relevant MeSH terms:
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Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases