Platelet Rich Fibrin on Root Coverage of Gingival Recessions

Gingival Recession Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04248049
• Other study ID #: Universidad Antonio Nariño
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: November 30, 2019

Study information

• Verified date: January 2020
• Source: Universidad Antonio Nariño
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: November 30, 2019
• Est. primary completion date: August 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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 ? 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

Related Conditions & MeSH terms

• Gingival Recession

Intervention

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)

Locations

Country	Name	City	State
Colombia	Universidad Antonio Nariño	Bogotá

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Antonio Nariño

Country where clinical trial is conducted

Colombia, 

References & Publications (4)

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. — View 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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).	baseline, 1, 3 , 6, 9, 12 and 24 months
Secondary	Horizontal gingival recession (HGR)	Measured horizontally between two borders of the recession. (measured using a periodontal probe in millimeters).	baseline, 1, 3 , 6, 9, 12 and 24 months
Secondary	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).	baseline, 1, 3 , 6, 9, 12 and 24 months
Secondary	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.	baseline, 1, 3 , 6, 9, 12 and 24 months
Secondary	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).	baseline, 1, 3 , 6, 9, 12 and 24 months
Secondary	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.	baseline, 1, 3 , 6, 9, 12 and 24 months
Secondary	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.	baseline, 1, 3 , 6, 9, 12 and 24 months
Secondary	Visual analog scale (VAS)	Visual analog scale	baseline, 1, 3 , 6, 9, 12 and 24 months
Secondary	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	baseline, 1, 3 , 6, 9, 12 and 24 months