Biofunctionalization of a Volume-stable Collagen Matrix (VCMX) for the Treatment of Single Gingival Recession

Last updated: June 14, 2023
Sponsor: Universidade Estadual Paulista Júlio de Mesquita Filho
Overall Status: Active - Recruiting

Phase

N/A

Condition

Periodontitis

Treatment

Chlorhexidine rinse

VCMX

Sodium dipyrone

Clinical Study ID

NCT05916742
VCMX+iPRF
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The treatment of single gingival recessions comprises different well-established techniques, and the association between coronally advanced flap (CAF) and the subepithelial connective tissue graft is considered the gold standard. However, despite the excellent clinical results obtained, the use of subepithelial connective tissue graft is related to an increased risk of trans and postoperative bleeding, a longer duration of the surgical procedure and greater postoperative pain and morbidity. To overcome these limitations and increase patient acceptance, new biomaterials have been developed as possible alternatives to the use of connective tissue graft. Recently, tissue engineering has been investigating collagen matrices as carriers of biologically active substances. In vitro and in vivo studies have shown that the biofunctionalization of these matrices using injectable platelet rich-fibrin (i-PRF) can optimize the healing process of soft tissues using own's patient regenerative components. However, although it has promising potential, clinical studies evaluating the performance of functionalized collagen matrices are still scarce in the literature. Thus, the present study aims to evaluate the clinical, esthetic, patient-centered, immuno and microbiological results of the use of the biofunctionalized volume stable collagen matrix (VCMX) for the treatment of single gingival recessions RT1. For such purpose, a randomized controlled clinical trial of superiority, parallel and blind will be carried out. Seventy-five patients with RT1 single gingival recession will be selected, who will be randomly allocated to one of the following groups: CAF+VCMX+i-PRF (n = 25), coronally advanced flap associated with VCMX functionalized with i-PRF; CAF+VCMX (n=25), coronally advanced flap associated with VCMX; and CAF group (n = 25), coronally advanced flap alone (CAF). The groups will be compared regarding clinical, esthetic and patient-centered outcomes at the baseline, three and six months after the surgical procedure. The microbiological evaluation will be performed at baseline, three and six months after surgery and the concentration of inflammatory markers and growth factors will be assessed before the procedure and 3, 7, 14, 30 and 60 days after treatment.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Presence of RT1 (Cairo et al., 2011) buccal single gingival recession (GR) on vitalupper or lower canines and premolars with intact root surface (visible CEJ).
  • Presence of dentin hypersensitivity (HD) and/or esthetic concerns related to GR.
  • Adults > 18 years old.
  • Systemically health.
  • No signs of active periodontal disease.
  • Full-mouth plaque and bleeding score ≤ 20%.
  • Written informed consent given.

Exclusion

Exclusion Criteria:

  • Smoking.
  • Contraindication for periodontal surgery.
  • Pregnancy.
  • Presence of orthodontic braces.
  • Medications known to interfere with periodontal healing.
  • Use of anticoagulants.

Study Design

Total Participants: 75
Treatment Group(s): 6
Primary Treatment: Chlorhexidine rinse
Phase:
Study Start date:
April 15, 2022
Estimated Completion Date:
December 18, 2023

Connect with a study center

  • São Paulo State University

    São José Dos Campos, São Paulo 12245-000
    Brazil

    Active - Recruiting

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