search
Back to results

Platelet Rich Fibrin on Root Coverage of Gingival Recessions

Primary Purpose

Gingival Recession

Status
Completed
Phase
Not Applicable
Locations
Colombia
Study Type
Interventional
Intervention
Platelet rich fibrin
Sponsored by
Universidad Antonio Nariño
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Recession focused on measuring platelet-rich fibrin, platelet concentrates, periodontal diseases

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Universidad Antonio Nariño

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental side

Control side

Arm Description

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

Roots covered with coronally advanced flap (CAR)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Vertical gingival recession (VGR)
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).
Horizontal gingival recession (HGR)
Measured horizontally between two borders of the recession. (measured using a periodontal probe in millimeters).
Probing depth (PD)
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).
Clinical attachment level(CAL)
Two measurements will be used to calculate the CAL: the probing depth and the distance from the gingival margin to the CEJ.
Gingival tissue thickness
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).
Keratinized tissue height (KTH)
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.
Gingival bleeding index (IS)
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.
Visual analog scale (VAS)
Visual analog scale
Evaluation of oral health impact on quality of life, using the Oral Health Impact Profile (OHIP-14) questionnaire.
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

Full Information

First Posted
September 4, 2019
Last Updated
January 29, 2020
Sponsor
Universidad Antonio Nariño
search

1. Study Identification

Unique Protocol Identification Number
NCT04248049
Brief Title
Platelet Rich Fibrin on Root Coverage of Gingival Recessions
Official Title
Clinical Evaluation of Coronal Advanced Flap and Platelet Rich Fibrin on Root Coverage of Gingival Recessions Over a Period of 24 Month.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
August 30, 2019 (Actual)
Study Completion Date
November 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidad Antonio Nariño

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession
Keywords
platelet-rich fibrin, platelet concentrates, periodontal diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized clinical trial (RCT) (Interventional)
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Split mouth design allowing to evaluate two conditions in the same patients
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental side
Arm Type
Experimental
Arm Description
Roots covered with coronally advanced flap (CAF) and platelet rich fibrin (PRF) (CAF+PRF)
Arm Title
Control side
Arm Type
Active Comparator
Arm Description
Roots covered with coronally advanced flap (CAR)
Intervention Type
Other
Intervention Name(s)
Platelet rich fibrin
Intervention Description
The roots of patients with diagnosis of gingival recessions will be covered with coronally advanced flap (CAF) and platelet rich fibrin (PRF) (CAF+PRF)
Primary Outcome Measure Information:
Title
Change of percentage of root coverage (PRC) from baseline at 12 and 24 months
Description
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
Time Frame
baseline, 1, 3 , 6, 9, 12 and 24 months
Secondary Outcome Measure Information:
Title
Vertical gingival recession (VGR)
Description
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).
Time Frame
baseline, 1, 3 , 6, 9, 12 and 24 months
Title
Horizontal gingival recession (HGR)
Description
Measured horizontally between two borders of the recession. (measured using a periodontal probe in millimeters).
Time Frame
baseline, 1, 3 , 6, 9, 12 and 24 months
Title
Probing depth (PD)
Description
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).
Time Frame
baseline, 1, 3 , 6, 9, 12 and 24 months
Title
Clinical attachment level(CAL)
Description
Two measurements will be used to calculate the CAL: the probing depth and the distance from the gingival margin to the CEJ.
Time Frame
baseline, 1, 3 , 6, 9, 12 and 24 months
Title
Gingival tissue thickness
Description
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).
Time Frame
baseline, 1, 3 , 6, 9, 12 and 24 months
Title
Keratinized tissue height (KTH)
Description
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.
Time Frame
baseline, 1, 3 , 6, 9, 12 and 24 months
Title
Gingival bleeding index (IS)
Description
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.
Time Frame
baseline, 1, 3 , 6, 9, 12 and 24 months
Title
Visual analog scale (VAS)
Description
Visual analog scale
Time Frame
baseline, 1, 3 , 6, 9, 12 and 24 months
Title
Evaluation of oral health impact on quality of life, using the Oral Health Impact Profile (OHIP-14) questionnaire.
Description
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
Time Frame
baseline, 1, 3 , 6, 9, 12 and 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Universidad Antonio Nariño
City
Bogotá
ZIP/Postal Code
110231
Country
Colombia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31428630
Citation
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.
Results Reference
background
PubMed Identifier
29769769
Citation
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.
Results Reference
background
PubMed Identifier
29326502
Citation
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.
Results Reference
background
PubMed Identifier
28551729
Citation
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.
Results Reference
background

Learn more about this trial

Platelet Rich Fibrin on Root Coverage of Gingival Recessions

We'll reach out to this number within 24 hrs