Clinical trial NCT06438094: The Influence of Non-Carious Cervical Lesions on Root Coverage
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gingival Recession
Lead sponsor: Universitat Internacional de Catalunya
Sponsor class: OTHER
First posted: 2024-05-31
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There are two treatments but they are based on the tooth-level
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mean Root Coverage (MRC)
timeFrame: 6 months
Secondary outcomes:
measure: Complete Root Coverage (CRC)
timeFrame: 6 months
measure: Change in keratinized tissue width (ΔKTW)
timeFrame: 6 weeks, 3 months, 6 months
measure: Change in marginal gingival thickness (ΔMGT)
timeFrame: 6 weeks, 3 months, 6 months
measure: Change in recession depth (ΔRD)
timeFrame: 6 weeks, 3 months, 6 months
measure: Change in recession area (ΔRA)
timeFrame: 6 weeks, 3 months, 6 months
measure: Change in mucosal volume (ΔMV)
timeFrame: 6 weeks, 3 months, 6 months
measure: Probing pocket depth (PPD)
timeFrame: 6 months
measure: Clinical attachment level (CAL)
timeFrame: 6 months
measure: Dentin sensitivity as assessed by VAS (Visual Analog Scale)
timeFrame: Initial, 6 months
measure: Patient aesthetic satisfaction as assessed by VAS (Visual Analog Scale)
timeFrame: 6 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: BLASI Clínica Dental Barcelona
Study officials:
affiliation: Universitat Internacional de Catalunya
name: Gonzalo Blasi
role: STUDY_DIRECTOR
affiliation: Universitat Internacional de Catalunya
name: José Nart
role: PRINCIPAL_INVESTIGATOR
References: