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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Type A gingival recession defects | Experimental | Gingival recession defects that present with a visible CEJ. These defects will receive root coverage surgery only. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Root Coverage (MRC) | Mean root coverage assessed in percentage | 6 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gonzalo Blasi | Universitat Internacional de Catalunya | Study Director |
| José Nart | Universitat Internacional de Catalunya | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BLASI Clínica Dental Barcelona | Barcelona | Barcelona | 08021 | Spain |
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There are two treatments but they are based on the tooth-level
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| 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. |
|
| 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 |
| ID | Term |
|---|---|
| D005889 | Gingival Recession |
| ID | Term |
|---|---|
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D055093 | Periodontal Atrophy |
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