Gingival Recession
Conditions
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.
Interventions
PROCEDURERoot 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.
PROCEDUREReconstruction 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.
Sponsors
Gonzalo Blasi
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
There are two treatments but they are based on the tooth-level
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Root Coverage (MRC) | 6 months | Mean root coverage assessed in percentage |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
| Change in mucosal volume (ΔMV) | 6 weeks, 3 months, 6 months | change in mucosal volume assessed digitally in mm\^3 |
| 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 \[0-100\] |
| Patient aesthetic satisfaction as assessed by VAS (Visual Analog Scale) | 6 months | Patient aesthetic satisfaction assessed using a Visual Analog Scale \[0-100\] |
Countries
Spain
Contacts
STUDY_DIRECTORGonzalo Blasi
Universitat Internacional de Catalunya
PRINCIPAL_INVESTIGATORJosé Nart
Universitat Internacional de Catalunya
Outcome results
None listed