Platelet Rich Fibrin on Root Coverage of Gingival Recessions

NCT04248049 | Completed

• 1 other identifier: Universidad Antonio Nariño
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Several surgical techniques and various adjunctive agents have been used to covered Gingival Recession (GR) and promote clinical outcomes. The treatment of the GR more used (gold standard) is the root coverage with surgical procedures and connective tissue graft, but it has limitations due to the conditions of the donor graft. Is necessary develop other biomaterials for these cases. The platelet rich fibrin is a autologous biomaterial that has gained tremendous momentum having been utilized for a variety of dental and medical procedures including periodontal surgeries. However, results remain contradictory and mainly focus on the hard and soft tissue healing, aesthetics and postoperative discomfort. The objective of this study was to evaluate the clinical effects of coronal advanced flap (CAF) and CAF + Platelet Rich Fibrin (PRF) on Root coverage (RC) over a period of 24 month.

Conditions

Gingival Recession

Keywords

platelet-rich fibrin; platelet concentrates; periodontal diseases

Outcome Measures

Primary Outcomes (1)

• Change of percentage of root coverage (PRC) from baseline at 12 and 24 months

  Complete root coverage after surgical correction measured in percentage by using periodontal probe. PRC= Preoperative recession depth - Postoperative recession depth X 100 % Preoperative recession depth

  baseline, 1, 3 , 6, 9, 12 and 24 months

Secondary Outcomes (9)

• Vertical gingival recession (VGR)

  baseline, 1, 3 , 6, 9, 12 and 24 months

• Horizontal gingival recession (HGR)

  baseline, 1, 3 , 6, 9, 12 and 24 months

• Probing depth (PD)

  baseline, 1, 3 , 6, 9, 12 and 24 months

• Clinical attachment level(CAL)

  baseline, 1, 3 , 6, 9, 12 and 24 months

• Gingival tissue thickness

  baseline, 1, 3 , 6, 9, 12 and 24 months

Study Arms (2)

Experimental side

EXPERIMENTAL

Roots covered with coronally advanced flap (CAF) and platelet rich fibrin (PRF) (CAF+PRF)

Other: Platelet rich fibrin

Control side

ACTIVE COMPARATOR

Roots covered with coronally advanced flap (CAR)

Other: Platelet rich fibrin

Interventions

Platelet rich fibrin OTHER

The roots of patients with diagnosis of gingival recessions will be covered with coronally advanced flap (CAF) and platelet rich fibrin (PRF) (CAF+PRF)

Control side; Experimental side

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participant is willing and able to give informed consent for participation in the study
• Healthy males and females of age 18-60 years old
• Multiple bilateral (maxillary or mandibular) gingival recessions (Miller class І or II)
• Good oral hygiene (O´Leary index ≤ 15%)

You may not qualify if:

• Active periodontal disease
• Periodontal surgeries in the last three years
• Pregnancy or lactation
• Smokers or alcoholics
• Platelet dysfunction syndrome or thrombocytopenia
• Coagulation defects
• Uncontrolled diabetes
• Medical contraindications to elective oral surgery procedures
• Severe immunodeficiencies
• Oncological history
• Prosthetic restorations adjacent to gingival recessions
• Mobility II or III
• Occlusal contacts excessive
• Root caries
• Buccal restaurations Class V

Sponsors & Collaborators

• Universidad Antonio Nariño: lead

Study Sites (1)

Universidad Antonio Nariño

Bogotá, 110231, Colombia

Location

Related Publications (4)

• Li R, Liu Y, Xu T, Zhao H, Hou J, Wu Y, Zhang D. The Additional Effect of Autologous Platelet Concentrates to Coronally Advanced Flap in the Treatment of Gingival Recessions: A Systematic Review and Meta-Analysis. Biomed Res Int. 2019 Jul 25;2019:2587245. doi: 10.1155/2019/2587245. eCollection 2019.

  PMID: 31428630 BACKGROUND

• Debnath K, Chatterjee A. Evaluation of periosteum eversion and coronally advanced flap techniques in the treatment of isolated Miller's Class I/II gingival recession: A comparative clinical study. J Indian Soc Periodontol. 2018 Mar-Apr;22(2):140-149. doi: 10.4103/jisp.jisp_5_18.

  PMID: 29769769 BACKGROUND

• Mufti S, Dadawala SM, Patel P, Shah M, Dave DH. Comparative Evaluation of Platelet-Rich Fibrin with Connective Tissue Grafts in the Treatment of Miller's Class I Gingival Recessions. Contemp Clin Dent. 2017 Oct-Dec;8(4):531-537. doi: 10.4103/ccd.ccd_325_17.

  PMID: 29326502 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 BACKGROUND

MeSH Terms

Conditions

Gingival Recession; Periodontal Diseases

Condition Hierarchy (Ancestors)

Gingival Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Split mouth design allowing to evaluate two conditions in the same patients
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized clinical trial (RCT) (Interventional)

Study Record Dates

• First Submitted: September 4, 2019
• First Posted: January 30, 2020
• Study Start: January 1, 2018
• Primary Completion: August 30, 2019
• Study Completion: November 30, 2019
• Last Updated: January 30, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)