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

Intrabony Periodontal Defect Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03900013
• Other study ID #: MASH2019
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 20, 2019
• Est. completion date: December 20, 2021

Study information

• Verified date: February 2021
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 20, 2021
• Est. primary completion date: October 20, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 50 Years

Eligibility

Inclusion Criteria:

1. 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.

2. Defect not extending to a root furcation area

3. Vital teeth

4. Non-smokers.

5. No history of intake of antibiotics or other medications affecting the periodontium in the previous 6 months.

6. No periodontal therapy carried out in the past 6 months.

7. Able to sign an informed consent form.

8. Patients age between 25 and 50 years old.

9. Patients who are cooperative, motivated, and hygiene conscious.

10. Systemically free according to Cornell Medical Index

Exclusion Criteria:

1. Pregnancy or breast feeding

2. The presence of an orthodontic appliance

3. Teeth mobility greater than grade I

Related Conditions & MeSH terms

• Intrabony Periodontal Defect
• Periodontitis

Intervention

Procedure:
• Injectable platelet rich fibrin combined with DFDBA
The i-PRF will be mixed with bone graft then will be placed into the intraosseous defect
• Demineralized Freeze Dried Bone Allograft
Demineralized Freeze Dried Bone Allograft alone will be placed into the intraosseous defect

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (8)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	PD will be measured at base line, 3, 6, and 9 months postoperative
Secondary	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	Radiographic defect fill will be measured at base line, 6, and 9 months postoperative
Secondary	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.	RD will be measured at base line, 3, 6, and 9 months postoperative
Secondary	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	After 9 months postoperative