Clinical Assessment of Caries Restorations in the posterior tooth with bulk-fill resin

• Register: REBEC
• Last refreshed on: 29 May 2023
• Main ID: RBR-9z6hx2
• Date of registration: 06/06/2018
• Prospective Registration: No
• Primary sponsor: Instituto de Ciência e Tecnologia - Universidade Estadual Paulista
• Public title: Clinical Assessment of Caries Restorations in the posterior tooth with bulk-fill resin
• Scientific title: Longitudinal Clinical Assessment of Class II Cavity Restorations Using Bulk-Fill Technique: A Randomized Clinical Study
• Date of first enrolment: 01/12/2014
• Recruitment status: Data analysis completed
• URL: http://ensaiosclinicos.gov.br/rg/RBR-9z6hx2
• Study type: Intervention
• Study design: Clinical trial of Treatment, randomized, controlled, parallel, double-blind, two arms
• Phase: N/A

Countries of recruitment

Brazil

Contacts

• Name: Taciana Marco Ferraz Caneppele
• Affiliation: Instituto de Ciência e Tecnologia - Universidade Estadual Paulista

• Name: Taciana Marco Ferraz Caneppele
• Affiliation: Instituto de Ciência e Tecnologia - Universidade Estadual Paulista

Key inclusion & exclusion criteria

Inclusion criteria: Necessity of two Class II restorations with composite resin for decayed teeth or the necessity of changing the restoration; teeth which can be fully isolated; presence of antagonist and adjacent tooth; and teeth with vital pulp; no pain; direct pulp capping and no history of hypersensitivity
Exclusion criteria: Very extensive caries lesion; pulp exposure during caries removal or cavities with a high risk of exposure; allergies to the materials to be used


Age minimum: 18Y
Age maximum: 60Y
Gender: -

Health Condition(s) or Problem(s) studied

Dental Caries; Dental Leakage; Dental Restoration Wear; Dental Restoration Failure

C07.793.221

E06.323.400

C07.793.720.210

E06.780.346.737.125

Intervention(s)

D25.339

Procedure/surgery

The restoration procedures were performed by three calibrated operators. Firstly, inter-proximal radiographic examination was performed. The cavity depth was ranked after complete removal of the failed restoration or carious lesion and then the tooth was fully isolated. In those cases of deep lesions, glass-ionomer cement was used in the pulp wall. Enamel and dentin were etched with 37% phosphoric acid gel for 30 and 15 seconds, respectively. An adhesive system (Single Bond Adper – 3M ESPE) was used according to the manufacturer’s recommendations. Sectional matrices (Unimatrix System, TDV, Pomerode, SC, Brazil) were used for restoration in association with distancing ring and wooden wedge.
Each patient received two restorations, according to the randomization process performed by a specific software (www.sealedenvelop.com): 1)Intervention: Thirty-five restorations with bulk-fill resin SDR (Smart Dentine Replacement, Dentsply), in which the resin is slowly applied at the deepest point of the cavity, letting the tip of the applicator immersed until reaching 4 mm inside the cavity and then light cured for 20 seconds (power density of 900mW/cm2), with the final 2-mm of the cavity being filled with Z350 resin (3M ESPE) and light cured for 20 seconds; 2)Control: Thirty-five restorations with conventional resin Z350 (3M ESPE) was performed using the incremental technique, with each increment being light cured for 20 seconds. Materials, manufacturers and compositions are listed in Table 1. After seven days, the restorations were adjusted when needed and polished

E06.323.428

Primary Outcome(s)

Retention failure of composite restorations will be evaluated by clinical assessment (visual inspection), considering a variation of at least 5% in the measurements after polishing, 6, 12 and 24 months

The presence of the fracture of the restoration will be evaluated by clinical assessment (visual inspection), considering a variation of at least 5% in the measurements after polishing, 6, 12 and 24 months

Secondary Outcome(s)

The presence of the Marginal discoloration of the restoration will be evaluated by clinical assessment (visual inspection), considering a variation of at least 5% in the measurements after polishing, 6, 12 and 24 months

The presence of the recurrence caries will be evaluated by clinical assessment (visual inspection), considering a variation of at least 5% in the measurements after polishing, 6, 12 and 24 months

Source(s) of Monetary Support

Instituto de Ciência e Tecnologia - Universidade Estadual Paulista

Secondary Sponsor(s)

Instituto de Ciência e Tecnologia - Universidade Estadual Paulista