Clinical trial NCT03900013: 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
Overall status: UNKNOWN
Phase: NA
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
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-04-02
Enrollment: 20
Sex: ALL
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical attachment level gain (CAL)
timeFrame: CAL will be measured at base line, 3, 6, and 9 months postoperative
Secondary outcomes:
measure: Probing Depth (PD)
timeFrame: PD will be measured at base line, 3, 6, and 9 months postoperative
measure: Radiographic defect fill (IBD)
timeFrame: Radiographic defect fill will be measured at base line, 6, and 9 months postoperative
measure: Gingival Recession Depth (RD)
timeFrame: RD will be measured at base line, 3, 6, and 9 months postoperative
measure: Post-surgical patient satisfaction
timeFrame: After 9 months postoperative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry Cairo University
Study officials:
affiliation: Cairo University
name: Manal Hosny, Professor
role: STUDY_DIRECTOR
References:
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.
citation: Ainamo J, Bay I. Problems and proposals for recording gingivitis and plaque. Int Dent J. 1975 Dec;25(4):229-35.
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.
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.
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.
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.
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.
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.