The Influence of Non-Carious Cervical Lesions on Root Coverage
- Conditions
- Gingival Recession
- Interventions
- 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 graftProcedure: Root coverage surgery by means of a coronally advanced flap combined with a connective tissue graft
- Registration Number
- NCT06438094
- Lead Sponsor
- Gonzalo Blasi
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 56
- 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).
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Type B 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 Gingival recession defects that do not present a visible CEJ. A cervical composite restoration will be done prior to root coverage surgery. Type A gingival recession defects Root coverage surgery by means of a coronally advanced flap combined with a connective tissue graft Gingival recession defects that present with a visible CEJ. These defects will receive root coverage surgery only.
- Primary Outcome Measures
Name Time Method Mean Root Coverage (MRC) 6 months Mean root coverage assessed in percentage
- Secondary Outcome Measures
Name Time Method Change in marginal gingival thickness (ΔMGT) 6 weeks, 3 months, 6 months Change in marginal gingival thickness assessed at 1, 2, and 3 mm from the gingival margin in mm
Change in recession depth (ΔRD) 6 weeks, 3 months, 6 months Change in recession depth assessed digitally in mm
Change in recession area (ΔRA) 6 weeks, 3 months, 6 months change in recession area assessed digitally in mm\^2
Patient aesthetic satisfaction as assessed by VAS (Visual Analog Scale) 6 months Patient aesthetic satisfaction assessed using a Visual Analog Scale \[0-100\]
Probing pocket depth (PPD) 6 months probing pocket depth assessed clinically in mm using a periodontal probe
Clinical attachment level (CAL) 6 months Clinical attachment level assessed clinically in mm (sum of probing pocket depth and recession)
Dentin sensitivity as assessed by VAS (Visual Analog Scale) Initial, 6 months 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 \[0-100\]
Complete Root Coverage (CRC) 6 months Complete Root Coverage assessed in percentage
Change in keratinized tissue width (ΔKTW) 6 weeks, 3 months, 6 months Change in keratinized tissue width assessed digitally in mm
Change in mucosal volume (ΔMV) 6 weeks, 3 months, 6 months change in mucosal volume assessed digitally in mm\^3
Trial Locations
- Locations (1)
BLASI Clínica Dental Barcelona
🇪🇸Barcelona, Spain