The Influence of Non-Carious Cervical Lesions on Root Coverage

NCT06438094 | Recruiting

• 1 other identifier: PER-ECL-2022-01
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gingival Recession

Outcome Measures

Primary Outcomes (1)

• Mean Root Coverage (MRC)

  Mean root coverage assessed in percentage

  6 months

Secondary Outcomes (10)

• Complete Root Coverage (CRC)

  6 months

• Change in keratinized tissue width (ΔKTW)

  6 weeks, 3 months, 6 months

• Change in marginal gingival thickness (ΔMGT)

  6 weeks, 3 months, 6 months

• Change in recession depth (ΔRD)

  6 weeks, 3 months, 6 months

• Change in recession area (ΔRA)

  6 weeks, 3 months, 6 months

Study Arms (2)

Type A gingival recession defects

EXPERIMENTAL

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

Type B gingival recession defects

EXPERIMENTAL

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

Interventions

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

A root coverage surgery will be performed using Zucchelli et al.'s coronally advanced flap combined with a connective tissue graft from the palate.

Type A gingival recession defects

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

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.

Type B gingival recession defects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gonzalo Blasi: lead

Study Sites (1)

BLASI Clínica Dental Barcelona

Barcelona, 08021, Spain

RECRUITING

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Officials

• Gonzalo Blasi

  Universitat Internacional de Catalunya

  STUDY DIRECTOR

• José Nart

  Universitat Internacional de Catalunya

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gonzalo Blasi

CONTACT

620387688; gonzaloblasi@uic.es

Lory Abrahamian

CONTACT

722528012; lory.abrahamian@uic.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical professor

Model Details: There are two treatments but they are based on the tooth-level

Study Record Dates

• First Submitted: May 26, 2024
• First Posted: May 31, 2024
• Study Start: May 26, 2024
• Primary Completion (Estimated): May 25, 2026
• Study Completion (Estimated): May 25, 2026
• Last Updated: June 4, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)