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Clinical Trials/NCT04248049
NCT04248049
Completed
Not Applicable

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

Universidad Antonio Nariño1 site in 1 country15 target enrollmentJanuary 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gingival Recession
Sponsor
Universidad Antonio Nariño
Enrollment
15
Locations
1
Primary Endpoint
Change of percentage of root coverage (PRC) from baseline at 12 and 24 months
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2018
End Date
November 30, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Universidad Antonio Nariño
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Probing depth (PD)(baseline, 1, 3 , 6, 9, 12 and 24 months)
  • Gingival bleeding index (IS)(baseline, 1, 3 , 6, 9, 12 and 24 months)
  • Vertical gingival recession (VGR)(baseline, 1, 3 , 6, 9, 12 and 24 months)
  • Clinical attachment level(CAL)(baseline, 1, 3 , 6, 9, 12 and 24 months)
  • Gingival tissue thickness(baseline, 1, 3 , 6, 9, 12 and 24 months)
  • Visual analog scale (VAS)(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.(baseline, 1, 3 , 6, 9, 12 and 24 months)
  • Horizontal gingival recession (HGR)(baseline, 1, 3 , 6, 9, 12 and 24 months)
  • Keratinized tissue height (KTH)(baseline, 1, 3 , 6, 9, 12 and 24 months)

Study Sites (1)

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