Advanced Platelet Rich Fibrin in Periodontal Angular Defects

NCT03433066 | Unknown

• 1 other identifier: platelet rich fibrin
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intrabony Periodontal Defect

Keywords

advanced platelet-rich fibrin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Probing depth change:

  Baseline , 3 and 6 months postoperatively

• Radiographic bone density

  Baseline and 6 months postoperatively

• Radiographic bone fill

  Baseline and 6 months postoperatively

Study Arms (2)

group I (Test)

EXPERIMENTAL

Advanced platelet-rich fibrin mixed with biphasic alloplast

Procedure: Advanced platelet-rich fibrin mixed with biphasic alloplast

Group II (control)

ACTIVE COMPARATOR

Biphasic alloplast mixed with saline

Procedure: Biphasic alloplast mixed with saline

Interventions

Advanced platelet-rich fibrin mixed with biphasic alloplast PROCEDURE

mucoperiosteal flaps will be reflected to expose the defects , which will be debrided properly and finally filled with the freshly prepared Advanced platelet-rich fibrin mixed with the biphasic alloplast.

group I (Test)

Biphasic alloplast mixed with saline PROCEDURE

mucoperiosteal flap will be reflected to expose and clean the intrabony defect ,then it will be filled with biphasic alloplast mixed with saline.

Group II (control)

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Periodontology department, Faculty of Dentistry, Alexandria University

Alexandria, 21500, Egypt

Location

Related Publications (7)

• 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.

  PMID: 27672729 BACKGROUND

• 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.

  PMID: 19961389 BACKGROUND

• 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. doi: 10.1016/j.tripleo.2005.07.012.

  PMID: 16504861 BACKGROUND

• 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.

  PMID: 23731763 BACKGROUND

• 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. doi: 10.1902/jop.2009.090531.

  PMID: 20373539 BACKGROUND

• 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.

  PMID: 25954068 BACKGROUND

• 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.

  PMID: 25972081 BACKGROUND

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Mohy Eldin A. ElRashidy, Professor

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor Jaylane Kadry Ghonima

Model Details: This clinical study will be conducted on twenty-two (22) interproximal intrabony defects in patients with moderate to severe chronic periodontitis.These patients will be divided randomly into two groups: * Group I: (test) will include eleven interproximal intrabony defects that will be treated with (Advanced platelet rich fibrin \& biphasic alloplast) * Group II: (control) will include eleven interproximal intrabony defects that will be treated with (biphasic alloplast mixed with saline.)

Study Record Dates

• First Submitted: February 8, 2018
• First Posted: February 14, 2018
• Study Start: March 1, 2018
• Primary Completion: March 1, 2019
• Study Completion: June 1, 2019
• Last Updated: February 5, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)