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

Primary Purpose

Intrabony Periodontal Defect

Status

Unknown status

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Injectable platelet rich fibrin combined with DFDBA

Demineralized Freeze Dried Bone Allograft

About this trial

This is an interventional treatment trial for Intrabony Periodontal Defect focused on measuring Injectable platelet rich fibrin, I-PRF, Demineralized Freeze-Dried Bone Allograft, DFDBA, Stage 3 periodontitis, 3 wall intraosseous defect, 2 wall intraosseous defect

Eligibility Criteria

25 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Faculty of Dentistry Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Injectable Platelet Rich Fibrin (i-PRF) with DFDBA

Demineralized Freeze-Dried Bone Allograft (DFDBA) alone

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Probing Depth (PD)

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.

Radiographic defect fill (IBD)

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

Gingival Recession Depth (RD)

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.

Post-surgical patient satisfaction

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

Full Information

NCT ID

NCT03900013

First Posted

March 31, 2019

Last Updated

February 2, 2021

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT03900013

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Unknown status

Study Start Date

September 20, 2019 (Actual)

Primary Completion Date

October 20, 2021 (Anticipated)

Study Completion Date

December 20, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Masking Description

Due to the type of intervention, only the outcome assessor and the statistician will be blinded.

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Injectable Platelet Rich Fibrin (i-PRF) with DFDBA

Arm Type

Experimental

Arm Description

Arm Title

Demineralized Freeze-Dried Bone Allograft (DFDBA) alone

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Injectable platelet rich fibrin combined with DFDBA

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Demineralized Freeze Dried Bone Allograft

Intervention Description

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

Primary Outcome Measure Information:

Title

Clinical attachment level gain (CAL)

Description

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.

Time Frame

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

Secondary Outcome Measure Information:

Title

Probing Depth (PD)

Description

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.

Time Frame

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

Title

Radiographic defect fill (IBD)

Description

Time Frame

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

Title

Gingival Recession Depth (RD)

Description

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.

Time Frame

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

Title

Post-surgical patient satisfaction

Description

Time Frame

After 9 months postoperative

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Manal Hosny, Professor

Organizational Affiliation

Cairo University

Official's Role

Study Director

Facility Information:

Facility Name

Faculty of Dentistry Cairo University

City

Cairo

ZIP/Postal Code

12613

Country

Egypt

12. IPD Sharing Statement

Citations:

PubMed Identifier

27783851

Citation

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.

Results Reference

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PubMed Identifier

1058834

Citation

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

Results Reference

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PubMed Identifier

19651823

Citation

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.

Results Reference

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PubMed Identifier

2614633

Citation

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.

Results Reference

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PubMed Identifier

12981181

Citation

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.

Results Reference

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PubMed Identifier

22126345

Citation

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.

Results Reference

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PubMed Identifier

28976904

Citation

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.

Results Reference

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PubMed Identifier

21740371

Citation

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.

Results Reference

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

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