Injectable Platelet Rich Fibrin With Demineralized Freeze-dried Bone Allograft in Treatment of Intraosseous Defects
February 2, 2021 updated by: Mashaal Mohammed Abdullah Mohammed, Cairo University
Clinical and Radiographic Evaluation of Injectable PRF With Demineralized Freeze-Dried Bone Allograft (DFDBA) Compared to (DFDBA) in Treatment of Intraosseous Defects in Patients With Stage III Periodontitis: A Randomized Clinical Trial
Clinical and radiographic evaluation of injectable platelet rich fibrin (i-PRF) and demineralized freeze-dried bone allograft (DFDBA) compared to demineralized freeze-dried bone allograft (DFDBA) alone in management of intraosseous defects in stage III periodontitis patients.
Study Overview
Status
Active, not recruiting
Conditions
Detailed Description
Intraosseous defects are defined by the apical location of the periodontal pocket to the alveolar crest.
In a recent radiographic study employing cone-beam computed tomography, a high prevalence of intraosseous defects 83% has been reported.
Treatment of intraosseous defects is clinically challenging, as they often require complex regenerative periodontal therapy.
Current regenerative techniques often employed in treatment of intraosseous defects demonstrate variation in improvement of clinical outcomes and degree of periodontal regeneration achieved.
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Cairo, Egypt, 12613
- Faculty of Dentistry Cairo University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Type III periodontitis patient having at least one tooth with 2-wall, 3-wall, or combined 2- to 3-wall intraosseous defect ≥ 3 mm in depth (assessed by bone sounding, radiographic examination) with clinical attachment level ≥ 5 mm and pocket depth ≥ 6 mm.
- Defect not extending to a root furcation area
- Vital teeth
- Non-smokers.
- No history of intake of antibiotics or other medications affecting the periodontium in the previous 6 months.
- No periodontal therapy carried out in the past 6 months.
- Able to sign an informed consent form.
- Patients age between 25 and 50 years old.
- Patients who are cooperative, motivated, and hygiene conscious.
- Systemically free according to Cornell Medical Index
Exclusion Criteria:
- Pregnancy or breast feeding
- The presence of an orthodontic appliance
- Teeth mobility greater than grade I
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Injectable Platelet Rich Fibrin (i-PRF) with DFDBA
In i-PRF assigned group, 10 cc of blood per intraosseous defect will be collected right after administering the anaesthesia and will be processed according to the technique proposed by Choukroun et al., 2017 (centrifuged at 700 rpm, for 2-3 minutes). The yellow part will be collected using a syringe and added to a cup that contains the bone grafting material. The i-PRF consolidated bone graft will placed into the intraosseous defect. |
The i-PRF will be mixed with bone graft then will be placed into the intraosseous defect
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Active Comparator: Demineralized Freeze-Dried Bone Allograft (DFDBA) alone
After debridement and intraoperative recordings, in the control group, the bone graft material will be placed in the intraosseous defect without overfilling.
|
Demineralized Freeze Dried Bone Allograft alone will be placed into the intraosseous defect
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical attachment level gain (CAL)
Time Frame: CAL will be measured at base line, 3, 6, and 9 months postoperative
|
CAL will be measured from the cemento-enamel junction to the bottom of the gingival sulcus/periodontal pocket using the University of North Carolina periodontal probe at six sites per tooth.
|
CAL will be measured at base line, 3, 6, and 9 months postoperative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Probing Depth (PD)
Time Frame: PD will be measured at base line, 3, 6, and 9 months postoperative
|
PD will be measured from the gingival margin to the bottom of the gingival sulcus/ periodontal pocket using the University of North Carolina periodontal probe at six sites per tooth.
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PD will be measured at base line, 3, 6, and 9 months postoperative
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|
Radiographic defect fill (IBD)
Time Frame: Radiographic defect fill will be measured at base line, 6, and 9 months postoperative
|
The depth of intrabony defect will be measured from the alveolar bone crest to the base of the defect at baseline, six months and after nine months to detect the amount of bone fill Individually customized bite blocks and parallel-angle technique will be used to obtain standardized radiograph.
Radiographs will be scanned and the radiographic defect fill depth will be measured by a computer-aided software program
|
Radiographic defect fill will be measured at base line, 6, and 9 months postoperative
|
|
Gingival Recession Depth (RD)
Time Frame: RD will be measured at base line, 3, 6, and 9 months postoperative
|
RD will be measured from the cemento-enamel junction to the most apical extension of the gingival margin using the University of North Carolina periodontal probe at six sites per tooth.
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RD will be measured at base line, 3, 6, and 9 months postoperative
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Post-surgical patient satisfaction
Time Frame: After 9 months postoperative
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A 3-item questionnaire will be asked to the patients and shall use a 7-points answer scale. These items will be: Would you experience the same surgery another time? Would you advice others with the surgery? To what extent are you satisfied with the results? 7 points mean the best 1 means the worst |
After 9 months postoperative
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Ainamo J, Bay I. Problems and proposals for recording gingivitis and plaque. Int Dent J. 1975 Dec;25(4):229-35.
- Castro AB, Meschi N, Temmerman A, Pinto N, Lambrechts P, Teughels W, Quirynen M. Regenerative potential of leucocyte- and platelet-rich fibrin. Part A: intra-bony defects, furcation defects and periodontal plastic surgery. A systematic review and meta-analysis. J Clin Periodontol. 2017 Jan;44(1):67-82. doi: 10.1111/jcpe.12643. Epub 2016 Nov 24.
- Alsousou J, Thompson M, Hulley P, Noble A, Willett K. The biology of platelet-rich plasma and its application in trauma and orthopaedic surgery: a review of the literature. J Bone Joint Surg Br. 2009 Aug;91(8):987-96. doi: 10.1302/0301-620X.91B8.22546.
- Bowers GM, Chadroff B, Carnevale R, Mellonig J, Corio R, Emerson J, Stevens M, Romberg E. Histologic evaluation of new attachment apparatus formation in humans. Part III. J Periodontol. 1989 Dec;60(12):683-93. doi: 10.1902/jop.1989.60.12.683.
- BRODMAN K, ERDMANN AJ Jr, LORGE I, GERSHENSON CP, WOLFF HG. The Cornell Medical Index-health questionnaire. IV. The recognition of emotional disturbances in a general hospital. J Clin Psychol. 1952 May;8(3):289-93. doi: 10.1002/1097-4679(195207)8:33.0.co;2-b. No abstract available.
- Chang YC, Zhao JH. Effects of platelet-rich fibrin on human periodontal ligament fibroblasts and application for periodontal infrabony defects. Aust Dent J. 2011 Dec;56(4):365-71. doi: 10.1111/j.1834-7819.2011.01362.x. Epub 2011 Oct 13.
- Chenchev IL, Ivanova VV, Neychev DZ, Cholakova RB. Application of Platelet-Rich Fibrin and Injectable Platelet-Rich Fibrin in Combination of Bone Substitute Material for Alveolar Ridge Augmentation - a Case Report. Folia Med (Plovdiv). 2017 Sep 1;59(3):362-366. doi: 10.1515/folmed-2017-0044.
- Del Corso M, Vervelle A, Simonpieri A, Jimbo R, Inchingolo F, Sammartino G, Dohan Ehrenfest DM. Current knowledge and perspectives for the use of platelet-rich plasma (PRP) and platelet-rich fibrin (PRF) in oral and maxillofacial surgery part 1: Periodontal and dentoalveolar surgery. Curr Pharm Biotechnol. 2012 Jun;13(7):1207-30. doi: 10.2174/138920112800624391.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 20, 2019
Primary Completion (Anticipated)
October 20, 2021
Study Completion (Anticipated)
December 20, 2021
Study Registration Dates
First Submitted
March 31, 2019
First Submitted That Met QC Criteria
March 31, 2019
First Posted (Actual)
April 2, 2019
Study Record Updates
Last Update Posted (Actual)
February 4, 2021
Last Update Submitted That Met QC Criteria
February 2, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MASH2019
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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