Clinical trial NCT04248049: 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
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Recession
Keywords: platelet-rich fibrin
platelet concentrates
periodontal diseases
Lead sponsor: Universidad Antonio Nariño
Sponsor class: OTHER
First posted: 2020-01-30
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trial (RCT) (Interventional)
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change of percentage of root coverage (PRC) from baseline at 12 and 24 months
timeFrame: baseline, 1, 3 , 6, 9, 12 and 24 months
Secondary outcomes:
measure: Vertical gingival recession (VGR)
timeFrame: baseline, 1, 3 , 6, 9, 12 and 24 months
measure: Horizontal gingival recession (HGR)
timeFrame: baseline, 1, 3 , 6, 9, 12 and 24 months
measure: Probing depth (PD)
timeFrame: baseline, 1, 3 , 6, 9, 12 and 24 months
measure: Clinical attachment level(CAL)
timeFrame: baseline, 1, 3 , 6, 9, 12 and 24 months
measure: Gingival tissue thickness
timeFrame: baseline, 1, 3 , 6, 9, 12 and 24 months
measure: Keratinized tissue height (KTH)
timeFrame: baseline, 1, 3 , 6, 9, 12 and 24 months
measure: Gingival bleeding index (IS)
timeFrame: baseline, 1, 3 , 6, 9, 12 and 24 months
measure: Visual analog scale (VAS)
timeFrame: baseline, 1, 3 , 6, 9, 12 and 24 months
measure: Evaluation of oral health impact on quality of life, using the Oral Health Impact Profile (OHIP-14) questionnaire.
timeFrame: baseline, 1, 3 , 6, 9, 12 and 24 months
Other outcomes:
Locations:
city: Bogotá
country: Colombia
facility: Universidad Antonio Nariño
Study officials:
References:
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.
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.
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.
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.