Clinical and Radiological Effect Of Platelet Rich Fibrin on the Healing of Periodontal Intrabony Periodontal Defects
Primary Purpose
Chronic Periodontitis, Intrabony Periodontal Defect
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Anorganic Bovine Bone Mineral (ABBM)
Anorganic Bovine Bone Mineral and Platelet Rich Fibrin (PRF)
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Periodontitis focused on measuring Anorganic bovine bone mineral;, Graft, Intrabony periodontal defect, platelet rich fibrin
Eligibility 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.
Sites / Locations
- Yasemin Sezgin
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
PRF and ABBM
Anorganic Bovine Bone Mineral
Arm Description
Intervention: Anorganic Bovine Bone Mineral and Platelet Rich fibrin is applied to the periodontal intrabony defects
Intervention: Anorganic Bovine Bone Mineral is applied to the periodontal intrabony defects
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Vertical bone loss change: Distance between cemento-enamel junction and base of the defect measured in standardized radiographs at baseline and 6 months postoperatively
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
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
Full Information
NCT ID
NCT02836314
First Posted
July 8, 2016
Last Updated
July 14, 2016
Sponsor
Baskent University
Collaborators
Gazi University
1. Study Identification
Unique Protocol Identification Number
NCT02836314
Brief Title
Clinical and Radiological Effect Of Platelet Rich Fibrin on the Healing of Periodontal Intrabony Periodontal Defects
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 Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baskent University
Collaborators
Gazi University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis, Intrabony Periodontal Defect
Keywords
Anorganic bovine bone mineral;, Graft, Intrabony periodontal defect, platelet rich fibrin
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PRF and ABBM
Arm Type
Experimental
Arm Description
Intervention: Anorganic Bovine Bone Mineral and Platelet Rich fibrin is applied to the periodontal intrabony defects
Arm Title
Anorganic Bovine Bone Mineral
Arm Type
Active Comparator
Arm Description
Intervention: Anorganic Bovine Bone Mineral is applied to the periodontal intrabony defects
Intervention Type
Other
Intervention Name(s)
Anorganic Bovine Bone Mineral (ABBM)
Intervention Description
In the control group, periodontal intrabony defects were treated with ABBM alone.
Intervention Type
Other
Intervention Name(s)
Anorganic Bovine Bone Mineral and Platelet Rich Fibrin (PRF)
Intervention Description
In the test group, periodontal intrabony defects were treated with ABBM and PRF combination.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
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
Title
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
10. Eligibility
Minimum Age & Unit of Time
38 Years
Maximum Age & Unit of Time
61 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Levent Taner, PhD, DDS
Organizational Affiliation
Gazi University, Faculty of Dentistry, Department of Periodontology
Official's Role
Study Director
Facility Information:
Facility Name
Yasemin Sezgin
City
Ankara
ZIP/Postal Code
06540
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Clinical and Radiological Effect Of Platelet Rich Fibrin on the Healing of Periodontal Intrabony Periodontal Defects
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