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Completed

NCT Number: NCT04248049

Platelet Rich Fibrin on Root Coverage of Gingival Recessions

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.

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Key information

Conditions

Gingival Recession Gingival Diseases Mouth Diseases Periodontal Atrophy Periodontal Diseases Stomatognathic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Antonio Nariño

Bogotá, 110231, Colombia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

platelet rich fibrin

Other

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 outcomes

  1. 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

  1. 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).

  2. 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).

  3. 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).

  4. 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.

  5. 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).

  6. 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.

  7. 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.

  8. Visual analog scale (VAS)

    Time frame: baseline, 1, 3 , 6, 9, 12 and 24 months

    Visual analog scale

  9. 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

Sponsors and collaborators

Lead sponsor

Universidad Antonio Nariño

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 30, 2020
Registry last updated
Jan 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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