The Influence of Non-Carious Cervical Lesions on Root Coverage

Last updated: June 2, 2024
Sponsor: Gonzalo Blasi
Overall Status: Active - Recruiting

Phase

N/A

Condition

Uterine Disorders

Periodontitis

Treatment

Root coverage surgery by means of a coronally advanced flap combined with a connective tissue graft

Reconstruction of the CEJ with a composite restoration followed by root coverage surgery by means of a coronally advanced flap combined with a connective tissue graft

Clinical Study ID

NCT06438094
PER-ECL-2022-01
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The goal of this prospective cohort study is to evaluate the effect of non-carious cervical lesions (NCCLs) on the outcome of root coverage therapy. The main question it aims to answer is: In gingival recessions associated with NCCLs, characterized by an undetectable cemento-enamel junction (CEJ), reconstruction of the CEJ with a cervical composite restoration, prior to root coverage surgery by means of a coronally advanced flap combined with a connective tissue graft (CAF+CTG), provides similar clinical and patient-reported outcomes, as compared to the treatment of gingival recessions associated with NCCLs, characterized by a visible CEJ, with root coverage surgery only, by means of a CAF+CTG.

In NCCLs where the CEJ is undetectable (B-type defect), the CEJ will be reconstructed before surgery with a cervical composite restoration mimicking the anatomic features of the contralateral, homologous tooth. CAF+CTG treatment will be performed in all cases. Participants will be assessed at 6 weeks, 3 months, and 6 months to evaluate clinical, volumetric, and patient-centred outcomes.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Systemically healthy individuals older than 18 years old;

  • Healthy periodontal status according to the AAP/EFP definition;

  • Full-mouth plaque (FMPS) and bleeding scores (FMBS) ≤ 20%;

  • At least one facial RT1 GR in single-rooted teeth with a minimum depth of 2 mm,associated with a NCCL;

  • No history of periodontal surgery at the experimental site(s).

Exclusion

Exclusion Criteria:

  • Pregnancy or lactation;

  • Self-reported smoking ≥10 cigarettes/day;

  • Metabolic diseases that negatively affect soft tissue healing (i.e., diabetesmellitus);

  • Any medication that may interfere with wound healing;

  • Prosthetic crown at experimental teeth;

  • Ongoing orthodontic therapy.

Study Design

Total Participants: 56
Treatment Group(s): 2
Primary Treatment: Root coverage surgery by means of a coronally advanced flap combined with a connective tissue graft
Phase:
Study Start date:
May 26, 2024
Estimated Completion Date:
May 25, 2026

Study Description

In this investigation, a prospective cohort study, several key outcomes will be assessed. First, we seek to determine whether restoring the cementoenamel junction (CEJ) in Class B GRs before root coverage therapy yields comparable clinical and volumetric outcomes to Class A GRs with detectable CEJ. In addition, the influence of the CEJ restoration on dentin sensitivity and aesthetic satisfaction of the patient will be investigated. To our knowledge, it will be the first clinical study to use Pini Prato et al.'s surface discrepancy classification as a decision-making tool to guide periodontal-restorative procedures.

Connect with a study center

  • BLASI Clínica Dental Barcelona

    Barcelona, 08021
    Spain

    Active - Recruiting

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