The Influence of Non-Carious Cervical Lesions on Root Coverage

Gonzalo Blasi

Status: Enrolling

Conditions: Gingival Recession

Treatments: Procedure: 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; Procedure: Root coverage surgery by means of a coronally advanced flap combined with a connective tissue graft

Study type: Interventional

Funder types: Other

Identifiers

NCT06438094

PER-ECL-2022-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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 criteria

• Pregnancy or lactation;
• Self-reported smoking ≥10 cigarettes/day;
• Metabolic diseases that negatively affect soft tissue healing (i.e., diabetes mellitus);
• Any medication that may interfere with wound healing;
• Prosthetic crown at experimental teeth;
• Ongoing orthodontic therapy.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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56 participants in 2 patient groups

Type A gingival recession defects

Experimental group

Description:

Gingival recession defects that present with a visible CEJ. These defects will receive root coverage surgery only.

Treatment:

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

Type B gingival recession defects

Experimental group

Description:

Gingival recession defects that do not present a visible CEJ. A cervical composite restoration will be done prior to root coverage surgery.

Treatment:

Procedure: 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