Intrabony Periodontal Defect Clinical Trial
Official title:
Evaluation of Advanced Platelet-rich Fibrin in Management of Periodontal Intrabony Defects
Verified date | February 2019 |
Source | Alexandria University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this study is to clinically and radiographically evaluate the efficacy of advanced platelet-rich fibrin (A-PRF) when used with biphasic alloplast in the management of intrabony defects in patients with moderate to severe chronic periodontitis.
Status | Active, not recruiting |
Enrollment | 22 |
Est. completion date | June 2019 |
Est. primary completion date | March 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 25 Years to 55 Years |
Eligibility |
Inclusion Criteria: - They should be diagnosed as having moderate -severe chronic periodontitis according to the American Academy of Periodontology classification on gingival and periodontal diseases (1999) - Clinical attachment loss (CAL) ,radiographic evidence of the presence of at least one intrabony defect. - Patient's age between 25 to 55 years. - Both sexes. - No periodontal surgeries in the area of interest during the previous 6 months. - The presence of intrabony defects (IBD) =3 mm deep (distance between alveolar crest and deepest point in the defect estimated from radiographs and confirmed upon surgical exposure). - An interproximal probing depth (PD) =5 mm and clinical attachment loss (CAL) =3mm after phase I therapy in maxillary/ mandibular teeth. - The presence of an adequate zone of keratinized gingiva at the facial aspect of the selected tooth. Exclusion Criteria: - Patients who could not maintain O'leary plaque index (54) =10% after phase I therapy. - Aggressive periodontitis patients. - Patients with systemic conditions known to affect the periodontal status, or, under medications known to affect the outcomes of periodontal therapy. - Pregnancy/lactation. - Smoking and tobacco use in any form. - Non vital teeth and teeth with grade III mobility. |
Country | Name | City | State |
---|---|---|---|
Egypt | Periodontology department, Faculty of Dentistry, Alexandria University | Alexandria |
Lead Sponsor | Collaborator |
---|---|
Alexandria University |
Egypt,
Agarwal A, Gupta ND, Jain A. Platelet rich fibrin combined with decalcified freeze-dried bone allograft for the treatment of human intrabony periodontal defects: a randomized split mouth clinical trail. Acta Odontol Scand. 2016;74(1):36-43. doi: 10.3109/00016357.2015.1035672. Epub 2015 May 14. — View Citation
Ajwani H, Shetty S, Gopalakrishnan D, Kathariya R, Kulloli A, Dolas RS, Pradeep AR. Comparative evaluation of platelet-rich fibrin biomaterial and open flap debridement in the treatment of two and three wall intrabony defects. J Int Oral Health. 2015 Apr;7(4):32-7. — View Citation
Choukroun J, Diss A, Simonpieri A, Girard MO, Schoeffler C, Dohan SL, Dohan AJ, Mouhyi J, Dohan DM. Platelet-rich fibrin (PRF): a second-generation platelet concentrate. Part V: histologic evaluations of PRF effects on bone allograft maturation in sinus lift. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Mar;101(3):299-303. — View Citation
Dohan Ehrenfest DM, Del Corso M, Diss A, Mouhyi J, Charrier JB. Three-dimensional architecture and cell composition of a Choukroun's platelet-rich fibrin clot and membrane. J Periodontol. 2010 Apr;81(4):546-55. — View Citation
Mazor Z, Horowitz RA, Del Corso M, Prasad HS, Rohrer MD, Dohan Ehrenfest DM. Sinus floor augmentation with simultaneous implant placement using Choukroun's platelet-rich fibrin as the sole grafting material: a radiologic and histologic study at 6 months. J Periodontol. 2009 Dec;80(12):2056-64. doi: 10.1902/jop.2009.090252. — View Citation
Miron RJ, Fujioka-Kobayashi M, Bishara M, Zhang Y, Hernandez M, Choukroun J. Platelet-Rich Fibrin and Soft Tissue Wound Healing: A Systematic Review. Tissue Eng Part B Rev. 2017 Feb;23(1):83-99. doi: 10.1089/ten.TEB.2016.0233. Epub 2016 Oct 10. Review. — View Citation
Perut F, Filardo G, Mariani E, Cenacchi A, Pratelli L, Devescovi V, Kon E, Marcacci M, Facchini A, Baldini N, Granchi D. Preparation method and growth factor content of platelet concentrate influence the osteogenic differentiation of bone marrow stromal cells. Cytotherapy. 2013 Jul;15(7):830-9. doi: 10.1016/j.jcyt.2013.01.220. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical attachment level change | The distance from cemento-enamel junction to the depth of the sulcus recorded by a periodontal probe at baseline , 3 and 6 months postoperatively | Baseline , 3 and 6 months posoperatively | |
Secondary | Probing depth change: | The distance from the gingival margin to the depth of the sulcus recorded by a periodontal probe at baseline and 6 months postoperatively | Baseline , 3 and 6 months postoperatively | |
Secondary | Radiographic bone density | Measuring the bone density before and after the procedure using CBCT | Baseline and 6 months postoperatively | |
Secondary | Radiographic bone fill | The actual bone formation in the intrabony defect measured on a CBCT in comparison to the baseline CBCT | Baseline and 6 months postoperatively |
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