Platelet Rich Fibrin and Autologous Fibrin Glue

NCT03734458 | Withdrawn DMC

• 1 other identifier: 17-24111 PRF+AFG
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Platelet-rich fibrin (PRF) and Autologous Fibrin Glue (AFG) are fibrin preparation derived from human blood samples and are used in regenerative dentistry. Aim: The aim of this study is to evaluate the level of root coverage using PRF (+) AFG with a coronally advanced flap (CAF) or PRF only with a CAF compared to a sub-epithelial connective tissue graft (CTG) with a CAF for treating Class 1 and 2 gingival recession defects. Additionally, to evaluate the level of keratinized tissue tissue thickness and width using PRF (+) AFG with a CAF or PRF only with a CAF compared to CTG with CAF for Class 1 and 2 gingival recession defects. Method: 48 patients with recession defects will be randomly divided into three different treatment groups. Treatment Group A (n=16) will consist of patients treated with PRF (+) AFG with a CAF, Group B (n=16) will consist of patients treated with PRF only with a CAF and Group C (n=16) will consits of patients treated with CTG with CAF as a control. Clinical measurements will be assessed at baseline and at 1 month and 6 months after the surgery. The clinical measurements that will be recorded, include probing depth, clinical attachment level, and gingval recession parameters. The gingival recession parameters include recession width, depth and thickness.

Conditions

Gingival Recession

Outcome Measures

Primary Outcomes (1)

• Evaluate the level of root coverage using PRF plus AFG with a coronally advanced flap or PRF only with a CAF compared to subepithelial connective tissue graft with a CAF for Class 1 and 2 gingival recession defects.

  To evaluate the level of root coverage using PRF plus AFG compared to CTG or PRF only compared to CTG

  Baseline to 6 months

Secondary Outcomes (1)

• Evaluate the level of keratinized tissue thickness and width using PRF plus AFG with a CAF, PRF only with a CAF or a SCTG with CAF for Class 1 and 2 gingival recession defects.

  Baseline to 6 months

Study Arms (3)

Group A - PRF plus AFG with a CAF

EXPERIMENTAL

Group A - PRF plus AFG with a CAF: The PRF will be prepared according to the protocol outlined by Choukroun 1. Prior to the surgical procedure, venous blood will be collected via venipuncture from the antecubital vein using one 10 ml sterile glass tube and one 10ml sterile plastic tube. The tubes will be immediately centrifuged at 1300 rpm for 8 minutes to obtain PRF. The fibrin clot formed in the middle part of the tube will be collected. The clot will be transferred to the PRF box and compressed to form a membrane. For the AFG, the liquid will be separated from the red blood cells from the plastic tube using a sterile syringe.

Other: Group A - PRF plus AFG with a CAF

Group B - PRF only with a CAF

EXPERIMENTAL

Group B - PRF only with a CAF: The PRF will be prepared according to the protocol outlined by Choukroun1. Prior to the surgical procedure, venous blood will be collected via venipuncture from the antecubital vein using one 10 ml sterile glass tube. The tubes will be immediately centrifuged at 1300 rpm for 8 minutes to obtain PRF. The fibrin clot formed in the middle part of the tube will be collected. The clot will be transferred to the PRF box and compressed to form a membrane.

Other: Group B - PRF only with a CAF

Group C - CTG with a CAF

ACTIVE COMPARATOR

Group C - CTG with a CAF: Sup-epithelial connective tissue harvest: The palatal donor site should be at least 3mm in thickness. A horizontal incision will be made on the palate 3mm from the maxillary canine to the first molar using a 15 blade. A sub-epithelial connective tissue graft will be harvested with adequate dimensions based on the recipient site. The graft will be sutured over the recipient site with 5-0 chromic gut sutures using a continuous mattress suturing technique.

Other: Group C - CTG with a CAF

Interventions

Group A - PRF plus AFG with a CAF OTHER

Group A - PRF plus AFG with a CAF will be used surgically to cover the exposed roots.

Group A - PRF plus AFG with a CAF

Group B - PRF only with a CAF OTHER

Group B - PRF only with a CAF will be used surgically to cover the exposed roots.

Group B - PRF only with a CAF

Group C - CTG with a CAF OTHER

Group C - CTG with a CAF will be used surgically to cover the exposed roots.

Group C - CTG with a CAF

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: 18years and over.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women aged 18 years or over
• Miller's Class 1 and Class 2 recession
• Localized gingival recession of 1-6mm present on 1 or 2 continuous single rooted teeth. Gingival recession is measured from the cemental-enamel junction (CEJ; a stable anatomical landmark on every tooth) to the gingival margin.

You may not qualify if:

• Current tobacco use (greater than 1 cigarette/week) or history of quitting \< 5 years previously (self reported)
• Poor oral hygiene (plaque index of 2 or greater) or active periodontal disease (diagnosis of moderate chronic periodontal disease or greater)
• Currently taking aspirin, prescription blood thinners
• Type II diabetes with HbA1c greater than 7
• Immunosuppressed or any other systemic condition that would disqualify subject as an acceptable surgical candidate

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

UCSF School of Dentistry

San Francisco, California, 94143, United States

Location

Related Publications (10)

• Choukroun J, Ghanaati S. Reduction of relative centrifugation force within injectable platelet-rich-fibrin (PRF) concentrates advances patients' own inflammatory cells, platelets and growth factors: the first introduction to the low speed centrifugation concept. Eur J Trauma Emerg Surg. 2018 Feb;44(1):87-95. doi: 10.1007/s00068-017-0767-9. Epub 2017 Mar 10.

  PMID: 28283682 BACKGROUND

• Miron RJ, Zucchelli G, Pikos MA, Salama M, Lee S, Guillemette V, Fujioka-Kobayashi M, Bishara M, Zhang Y, Wang HL, Chandad F, Nacopoulos C, Simonpieri A, Aalam AA, Felice P, Sammartino G, Ghanaati S, Hernandez MA, Choukroun J. Use of platelet-rich fibrin in regenerative dentistry: a systematic review. Clin Oral Investig. 2017 Jul;21(6):1913-1927. doi: 10.1007/s00784-017-2133-z. Epub 2017 May 27.

  PMID: 28551729 RESULT

• Dohan Ehrenfest DM, de Peppo GM, Doglioli P, Sammartino G. Slow release of growth factors and thrombospondin-1 in Choukroun's platelet-rich fibrin (PRF): a gold standard to achieve for all surgical platelet concentrates technologies. Growth Factors. 2009 Feb;27(1):63-9. doi: 10.1080/08977190802636713.

  PMID: 19089687 RESULT

• Dohan Ehrenfest DM, Bielecki T, Jimbo R, Barbe G, Del Corso M, Inchingolo F, Sammartino G. Do the fibrin architecture and leukocyte content influence the growth factor release of platelet concentrates? An evidence-based answer comparing a pure platelet-rich plasma (P-PRP) gel and a leukocyte- and platelet-rich fibrin (L-PRF). Curr Pharm Biotechnol. 2012 Jun;13(7):1145-52. doi: 10.2174/138920112800624382.

  PMID: 21740377 RESULT

• Oncu E. The Use of Platelet-Rich Fibrin Versus Subepithelial Connective Tissue Graft in Treatment of Multiple Gingival Recessions: A Randomized Clinical Trial. Int J Periodontics Restorative Dent. 2017 Mar/Apr;37(2):265-271. doi: 10.11607/prd.2741.

  PMID: 28196169 RESULT

• Dohan DM, Choukroun J, Diss A, Dohan SL, Dohan AJ, Mouhyi J, Gogly B. Platelet-rich fibrin (PRF): a second-generation platelet concentrate. Part II: platelet-related biologic features. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Mar;101(3):e45-50. doi: 10.1016/j.tripleo.2005.07.009. Epub 2006 Jan 10.

  PMID: 16504850 RESULT

• Dohan DM, Choukroun J, Diss A, Dohan SL, Dohan AJ, Mouhyi J, Gogly B. Platelet-rich fibrin (PRF): a second-generation platelet concentrate. Part III: leucocyte activation: a new feature for platelet concentrates? Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Mar;101(3):e51-5. doi: 10.1016/j.tripleo.2005.07.010.

  PMID: 16504851 RESULT

• Dohan DM, Choukroun J, Diss A, Dohan SL, Dohan AJ, Mouhyi J, Gogly B. Platelet-rich fibrin (PRF): a second-generation platelet concentrate. Part I: technological concepts and evolution. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Mar;101(3):e37-44. doi: 10.1016/j.tripleo.2005.07.008. Epub 2006 Jan 19.

  PMID: 16504849 RESULT

• 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 IV: clinical effects on tissue healing. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Mar;101(3):e56-60. doi: 10.1016/j.tripleo.2005.07.011.

  PMID: 16504852 RESULT

• 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 RESULT

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Officials

• Yogalakshmi Rajendran, BDS MS

  UCSF School of Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2018
• First Posted: November 8, 2018
• Study Start: July 1, 2019
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: October 8, 2019

Record last verified: 2019-10

Locations

US (1)