Injectable Platelet Rich Fibrin With Demineralized Freeze-dried Bone Allograft in Treatment of Intraosseous Defects

NCT03900013 | Unknown

• 1 other identifier: MASH2019
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intrabony Periodontal Defect

Keywords

Injectable platelet rich fibrin; I-PRF; Demineralized Freeze-Dried Bone Allograft; DFDBA; Stage 3 periodontitis; 3 wall intraosseous defect; 2 wall intraosseous defect

Outcome Measures

Primary Outcomes (1)

• Clinical attachment level gain (CAL)

  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 Outcomes (4)

• Probing Depth (PD)

  PD will be measured at base line, 3, 6, and 9 months postoperative

• Radiographic defect fill (IBD)

  Radiographic defect fill will be measured at base line, 6, and 9 months postoperative

• Gingival Recession Depth (RD)

  RD will be measured at base line, 3, 6, and 9 months postoperative

• Post-surgical patient satisfaction

  After 9 months postoperative

Study Arms (2)

Injectable Platelet Rich Fibrin (i-PRF) with DFDBA

EXPERIMENTAL

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.

Procedure: Injectable platelet rich fibrin combined with DFDBA

Demineralized Freeze-Dried Bone Allograft (DFDBA) alone

ACTIVE COMPARATOR

After debridement and intraoperative recordings, in the control group, the bone graft material will be placed in the intraosseous defect without overfilling.

Procedure: Demineralized Freeze Dried Bone Allograft

Interventions

Injectable platelet rich fibrin combined with DFDBA PROCEDURE

The i-PRF will be mixed with bone graft then will be placed into the intraosseous defect

Injectable Platelet Rich Fibrin (i-PRF) with DFDBA

Demineralized Freeze Dried Bone Allograft PROCEDURE

Demineralized Freeze Dried Bone Allograft alone will be placed into the intraosseous defect

Demineralized Freeze-Dried Bone Allograft (DFDBA) alone

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Pregnancy or breast feeding
• The presence of an orthodontic appliance
• Teeth mobility greater than grade I

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry Cairo University

Cairo, 12613, Egypt

Location

Related Publications (8)

• 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.

  PMID: 27783851 BACKGROUND

• Ainamo J, Bay I. Problems and proposals for recording gingivitis and plaque. Int Dent J. 1975 Dec;25(4):229-35.

  PMID: 1058834 BACKGROUND

• 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.

  PMID: 19651823 BACKGROUND

• 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.

  PMID: 2614633 BACKGROUND

• 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.

  PMID: 12981181 BACKGROUND

• 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.

  PMID: 22126345 BACKGROUND

• 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.

  PMID: 28976904 BACKGROUND

• 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.

  PMID: 21740371 BACKGROUND

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Manal Hosny, Professor

  Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the type of intervention, only the outcome assessor and the statistician will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 31, 2019
• First Posted: April 2, 2019
• Study Start: September 20, 2019
• Primary Completion: October 20, 2021
• Study Completion: December 20, 2021
• Last Updated: February 4, 2021

Record last verified: 2021-02

Locations

EG (1)