Platelet Rich Fibrin on Root Coverage of Gingival Recessions

NCT ID: NCT04248049

Last Updated: 2020-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2019-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Gingival Recession

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized clinical trial (RCT) (Interventional)
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Split mouth design allowing to evaluate two conditions in the same patients

Study Groups

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Experimental side

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

Group Type EXPERIMENTAL

Platelet rich fibrin

Intervention Type 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

Roots covered with coronally advanced flap (CAR)

Group Type ACTIVE_COMPARATOR

Platelet rich fibrin

Intervention Type 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)

Interventions

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Platelet rich fibrin

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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%)

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad Antonio Nariño

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Universidad Antonio Nariño

Bogotá, , Colombia

Site Status

Countries

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Colombia

References

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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.

Reference Type BACKGROUND
PMID: 31428630 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29769769 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29326502 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28551729 (View on PubMed)

Other Identifiers

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Universidad Antonio Nariño

Identifier Type: -

Identifier Source: org_study_id

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