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Platelet Rich Fibrin and Autologous Fibrin Glue

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ClinicalTrials.gov Identifier: NCT03734458
Recruitment Status : Withdrawn (IND application did not get approved)
First Posted : November 8, 2018
Last Update Posted : October 8, 2019
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

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.


Condition or disease Intervention/treatment Phase
Gingival Recession Other: Group A - PRF plus AFG with a CAF Other: Group B - PRF only with a CAF Other: Group C - CTG with a CAF Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Platelet Rich Fibrin and Autologous Fibrin Glue for Treating Periodontal Recession Defects: a Comparative Clinical Study
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021

Arm Intervention/treatment
Experimental: Group A - PRF plus AFG with a CAF
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 A - PRF plus AFG with a CAF will be used surgically to cover the exposed roots.

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

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




Primary Outcome Measures :
  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. [ Time Frame: Baseline to 6 months ]
    To evaluate the level of root coverage using PRF plus AFG compared to CTG or PRF only compared to CTG


Secondary Outcome Measures :
  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. [ Time Frame: Baseline to 6 months ]
    To evaluate the level of keratinized tissue thickness and width using PRF plus AFG compared to CTG or PRF only compared to CTG



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   18years and over.
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Men and women aged 18 years or over
  2. Miller's Class 1 and Class 2 recession
  3. 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.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03734458


Locations
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United States, California
UCSF School of Dentistry
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Yogalakshmi Rajendran, BDS MS UCSF School of Dentistry
Publications of Results:

Other Publications:
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03734458    
Other Study ID Numbers: 17-24111 PRF+AFG
First Posted: November 8, 2018    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gingival Recession
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Periodontal Atrophy