The Influence of Non-Carious Cervical Lesions on Root Coverage

The Influence of Non-Carious Cervical Lesions on Root Coverage by Means of Coronally Advanced Flap and a Connective Tissue Graft: A Prospective Cohort Study

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.

Study Overview

• Status: Terminated
• Conditions: Gingival Recession
• Intervention / Treatment: Procedure: Root coverage surgery by means of a coronally advanced flap combined with a connective tissue graft; 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

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Barcelona, Barcelona, Spain, 08021
      • BLASI Clínica Dental Barcelona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Type A gingival recession defects; Gingival recession defects that present with a visible CEJ. These defects will receive root coverage surgery only.	Procedure: Root coverage surgery by means of a coronally advanced flap combined with a connective tissue graft; A root coverage surgery will be performed using Zucchelli et al.'s coronally advanced flap combined with a connective tissue graft from the palate.
Experimental: Type B gingival recession defects; Gingival recession defects that do not present a visible CEJ. A cervical composite restoration will be done prior to root coverage surgery.	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; Reconstruction of the CEJ with a composite restoration will be performed in B+ and B- defects prior to root coverage surgery. A root coverage surgery will be performed using Zucchelli et al.'s coronally advanced flap combined with a connective tissue graft from the palate.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Root Coverage (MRC)	Mean root coverage assessed in percentage	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete Root Coverage (CRC)	Complete Root Coverage assessed in percentage	6 months
Change in keratinized tissue width (ΔKTW)	Change in keratinized tissue width assessed digitally in mm	6 weeks, 3 months, 6 months
Change in marginal gingival thickness (ΔMGT)	Change in marginal gingival thickness assessed at 1, 2, and 3 mm from the gingival margin in mm	6 weeks, 3 months, 6 months
Change in recession depth (ΔRD)	Change in recession depth assessed digitally in mm	6 weeks, 3 months, 6 months
Change in recession area (ΔRA)	change in recession area assessed digitally in mm^2	6 weeks, 3 months, 6 months
Change in mucosal volume (ΔMV)	change in mucosal volume assessed digitally in mm^3	6 weeks, 3 months, 6 months
Probing pocket depth (PPD)	probing pocket depth assessed clinically in mm using a periodontal probe	6 months
Clinical attachment level (CAL)	Clinical attachment level assessed clinically in mm (sum of probing pocket depth and recession)	6 months
Dentin sensitivity as assessed by VAS (Visual Analog Scale)	Dentin sensitivity assessed on each tooth after directing an air blast from a triple syringe at the buccal cervical areas, maintaining a distance of 1 cm for 5 seconds, using a Visual Analog Scale [0-100]	Initial, 6 months
Patient aesthetic satisfaction as assessed by VAS (Visual Analog Scale)	Patient aesthetic satisfaction assessed using a Visual Analog Scale [0-100]	6 months

Collaborators and Investigators

• Sponsor: Gonzalo Blasi
• Investigators: Study Director: Gonzalo Blasi, Universitat Internacional de Catalunya; Principal Investigator: José Nart, Universitat Internacional de Catalunya

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2024
• Primary Completion (Actual): April 1, 2026
• Study Completion (Actual): April 1, 2026

Study Registration Dates

• First Submitted: May 26, 2024
• First Submitted That Met QC Criteria: May 30, 2024
• First Posted (Actual): May 31, 2024

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: April 1, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Gingival Diseases; Gingival Recession
• Other Study ID Numbers: PER-ECL-2022-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No