Long-term clinical evaluation of composite resin restorations performed using BT Bioclear matrix system

INTERVENTION: This is a three‐arms, double‐blind, randomized controlled clinical trial. Before restorative procedures, where necessary, teeth will be anesthetized with a 3% mepivacaine solution (Mepisv, Nova DFL, Rio de Janeiro, RJ, Brazil) and cleaned with 3M Clinpro Glycine Prophy Powder, followed by rinsing and drying. Then, shade selection will be made using a shade guide. After rubber dam is placed, the restoration procedures will be conducted according to the following groups: Control group (conventional technique) / n = 120 restorations ‐ Conventional technique using Mylar matri Xstrips + Scothbond Universal Plus (ER)* + Filtek Universal (Capsules); Experimental group 1 (BT + warmed composite) / n = 120 restorations ‐ Alternative technique using BT Bioclear Matri XSystem + Scothbond Universal Plus (ER)* + Filtek Supreme flowable (Warmed) + Filtek Universal (Capsules / Warmed); and Experimental group 2 (BT + non‐warmed composite) / n = 120 restorations ‐ Alternative technique using BT Bioclear Matri XSystem + Scothbond Universal Plus (ER)* + Filtek Supreme flowable + Filtek Universal (Capsules / Non‐warmed). In the control group, after the mylar matri Xstrips and wedges are correctly inserted, a 37% phosphoric acid will be applied for 15 seconds, then rinsed and air‐dried. One coat of the Universal adhesive system Scothbond Universal Plus (3M Oral Care) will be gently scrubbed on the entire enamel and dentin surface for approximately 20 seconds, according to the manufacturer’s recommendations. Then, the adhesive will be evaporated by gentle air stream for 5 s and light cured for 10 s at 1200 mW/cm2 (Elipar, 3M Oral Care). After adhesive application, the resin composite Filtek Universal (3M Oral care) in capsules will be used, usually with one or two increments. The resin comp CONDITION: Dental carie. Dentin hypersensitivity E06.323.400 PRIMARY OUTCOME: The restorations will be evaluated by Modified World Federation criteria (FDI) at baseline (one week) and after 6,12, 24 and 36 months of clinical service. Only the clinically relevant measures for evaluation of adhesive and composite performance will be used and scored. The primary clinical endpoint will be restoration retention/fracture INCLUSION CRITERIA: Participants from both gender; must be in good general health; be at least 18 years old; have an acceptable oral hygiene level; present at least 20 teeth under occlusion; have at least three black spaces to be restored in anterior teeth (these black spaces have to be non‐retentive, with an average area higher than 1 mm2, and can involve only the enamel or both enamel and dentin, in vital teeth without mobility) SECONDARY OUTCOME: The following secondary endpoints will also be evaluated: Post‐operative sensitivity, marginal staining, marginal adaptation, gingival inflammation, fractures, surface texture, recurrence of caries and periodontal health. The evaluation of the spontaneous postoperative sensitivity will be performed one week after the restorative procedure by asking the patient if he experienced any pain during the period. During the restoration procedures, clinical time necessary to perform the restorations will also be evaluated. And finally, the patient view will also be considered in all the evaluation periods. These variables will be ranked according to modified FDI criteria into clinically very good, clinically good, clinically sufficient/ satisfactory, clinically unsatisfactory but repairable, and clinically poor (replacement required). In the case of marginal staining and marginal adaptation, the semiquantitative criteria (SQUACE) will be used