Platelet Rich Fibrin on Root Coverage of Gingival Recessions

January 29, 2020 updated by: Universidad Antonio Nariño

Clinical Evaluation of Coronal Advanced Flap and Platelet Rich Fibrin on Root Coverage of Gingival Recessions Over a Period of 24 Month.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
      • Bogotá, Colombia, 110231
        • Universidad Antonio Nariño

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental side
Roots covered with coronally advanced flap (CAF) and platelet rich fibrin (PRF) (CAF+PRF)
Other: 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)
Active Comparator: Control side
Roots covered with coronally advanced flap (CAR)
Other: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of percentage of root coverage (PRC) from baseline at 12 and 24 months
Time Frame: baseline, 1, 3 , 6, 9, 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vertical gingival recession (VGR)
Time Frame: baseline, 1, 3 , 6, 9, 12 and 24 months
It is measuring the distance from the cemento-enamel junction (CEJ) to the margin of the gingiva at the midbuccal point of the teeth (measured using a periodontal probe in millimeters).
baseline, 1, 3 , 6, 9, 12 and 24 months
Horizontal gingival recession (HGR)
Time Frame: baseline, 1, 3 , 6, 9, 12 and 24 months
Measured horizontally between two borders of the recession. (measured using a periodontal probe in millimeters).
baseline, 1, 3 , 6, 9, 12 and 24 months
Probing depth (PD)
Time Frame: baseline, 1, 3 , 6, 9, 12 and 24 months
It is measuring the distance from the gingival margin to the base of the pocket using periodontal probe. The probe will be inserted parallel to the long axis of the tooth using light force. (measured using a periodontal probe in millimeters).
baseline, 1, 3 , 6, 9, 12 and 24 months
Clinical attachment level(CAL)
Time Frame: baseline, 1, 3 , 6, 9, 12 and 24 months
Two measurements will be used to calculate the CAL: the probing depth and the distance from the gingival margin to the CEJ.
baseline, 1, 3 , 6, 9, 12 and 24 months
Gingival tissue thickness
Time Frame: baseline, 1, 3 , 6, 9, 12 and 24 months
The gingiva mid-buccally in the attached gingiva will be penetrated with an endodontic reamer with a silicon disc stop. The measure of penetration will be measured with dentimeter (mm).
baseline, 1, 3 , 6, 9, 12 and 24 months
Keratinized tissue height (KTH)
Time Frame: baseline, 1, 3 , 6, 9, 12 and 24 months
To measure the tissue thickness, a guiding device will be made to standardize the region to be measured and then, at a specific point, the mucosa will be punctured with an endodontic spacer and the thickness marked with a rubber marker. Then, using a digital caliper, the thickness will be measured.
baseline, 1, 3 , 6, 9, 12 and 24 months
Gingival bleeding index (IS)
Time Frame: baseline, 1, 3 , 6, 9, 12 and 24 months
Evaluation of the presence and absence of bleeding in the gingival margin through the gingival sulcus. The index is calculated after penetration of the sulcus by the periodontal probe, bleeding surfaces are noted and then counted. The index is calculated by dividing the number of surfaces that bleed by the total number of teeth and then multiplying by 100 to reach the percentage of bleeding index.
baseline, 1, 3 , 6, 9, 12 and 24 months
Visual analog scale (VAS)
Time Frame: baseline, 1, 3 , 6, 9, 12 and 24 months
Visual analog scale
baseline, 1, 3 , 6, 9, 12 and 24 months
Evaluation of oral health impact on quality of life, using the Oral Health Impact Profile (OHIP-14) questionnaire.
Time Frame: baseline, 1, 3 , 6, 9, 12 and 24 months
Evaluate the impact of oral health on patient's quality of life before and 1 year after implant installation. This evaluation will be carried out through the application of a questionnaire with 14 questions (Oral Health Impact Profile: OHIP-14) that assess the patient's perception regarding the impact of oral conditions on their well-being
baseline, 1, 3 , 6, 9, 12 and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Antonio Nariño

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

August 30, 2019

Study Completion (Actual)

November 30, 2019

Study Registration Dates

First Submitted

September 4, 2019

First Submitted That Met QC Criteria

January 29, 2020

First Posted (Actual)

January 30, 2020

Study Record Updates

Last Update Posted (Actual)

January 30, 2020

Last Update Submitted That Met QC Criteria

January 29, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Universidad Antonio Nariño

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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