Dental carie. Dentin hypersensitivity
Conditions
Interventions
E06.323.428
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, R
Experimental group 1 (BT + warmed composite) / n = 120 restorations - Alternative technique using BT Bioclear Matrix System + Scothbond Universal Plus (ER)* + Filtek Supreme flowable (Warmed) + Filte
and Experimental group 2 (BT + non-warmed composite) / n = 120 restorations - Alternative technique using BT Bioclear Matrix System + Scothbond Universal Plus (ER)* + Filtek Supreme flowable + Filtek
Sponsors
Universidade Federal Fluminense - Pólo de Nova Friburgo
Universidade Federal Fluminense - Pólo de Nova Friburgo
Eligibility
Age
18 Years to No maximum
Inclusion criteria
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)
Exclusion criteria
Exclusion criteria: Patients with extremely poor oral hygiene or using orthodontic devices; severe or chronic periodontitis or with more than 10 teeth with occlusal facets (premolars and molars); participants with known allergy to resin-based materials or any other material used in this study; pregnant or breastfeeding women; participants under chronic use of anti-inflammatory, analgesic, and psychotropic drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Brazil
Contacts
Public ContactMarcos Barceleiro
Universidade Federal Fluminense
Outcome results
None listed