Clinical evaluation of resin restorations of posterior teeth performed at the são luis dental specialty Center - randomized clinical trial

• Register: REBEC
• Last refreshed on: 29 May 2023
• Main ID: RBR-7hbmjp
• Date of registration: 10/03/2020
• Prospective Registration: No
• Primary sponsor: Suellen Nogueira Linares Lima
• Public title: Clinical evaluation of resin restorations of posterior teeth performed at the são luis dental specialty Center - randomized clinical trial
• Scientific title: Retrospective evaluation and randomized clinical trial of posterior direct restorations performed in dental specialty centers
• Date of first enrolment: 04/01/2018
• Recruitment status: Recruitment completed
• URL: http://ensaiosclinicos.gov.br/rg/RBR-7hbmjp
• Study type: Intervention
• Study design: Clinical treatment trial, parallel, with two arms, double-blind, randomized-controlled.
• Phase: N/A

Countries of recruitment

Brazil

Contacts

• Name: Suellen Linares Lima
• Affiliation: Universidade Ceuma

• Name: Matheus Coelho Bandeca
• Affiliation: Universidade Ceuma

Key inclusion & exclusion criteria

Inclusion criteria: Need restorative treatment with composite resin on 2 posterior teeth; aged between 18 and 70 years; agree to participate in the study; having a medical history that does not compromise the evolution of the results; having the habit of oral hygiene that involves brushing at least twice a day; having a normal periodontal condition in relation to the probing parameters.
Exclusion criteria: Patients with a chronic disease with oral manifestations; present any oral pathology considered serious; high caries activity; severe periodontal problem that may compromise the direct restoration of the posterior tooth; allergies to any material that will be used at work; signs or symptoms of bruxism and dental clenching; teeth that will be used as a pillar for removable dentures or fixed partial dentures; teeth with porcelain restoration directly opposite the tooth that will receive the research restoration.

Age minimum: 18Y
Age maximum: 70Y
Gender: -

Health Condition(s) or Problem(s) studied

dental caries

Intervention(s)

Procedure/surgery

E06.323.428

Control group (n=25 patients e 50 teeth): Before the restorative procedures all 25 patients will be guided and all selected teeth (n=50) will be radiographed with dental interproximal positioned for comparison in the evaluations. After removal of the dental caries, the enamel will be conditioned with 37% phosphoric acid for 30 s; Application of the universal adhesive system (Ambar Universal - FGM); Photoactivation for 20 s; insertion of the conventional composite resin Llis FGM by the incremental technique with 2mm increments, primarily inside the proximal walls; Photoactivation for 20 s in the mesial and distal proximal box; Insertion of the conventional composite resin Llis FGM inside the pulp wall in 2 mm increments until reaching the limit of the superficial cavity angle in the occlusal; Photoactivation for 20 s of activation, photographic taking and final periapical radiography.

Experimental group (n=25 patients e 50 teeth): Before the restorative procedures all 25 patients will be guided and all selected teeth (n=50) will be radiographed with an interproximal dental positioner for comparison in the evaluations. After removal of the dental caries, the enamel will be conditioned with 37% phosphoric acid for 30 s; Application of the universal adhesive system (Ambar Universal - FGM); photoactivation for 20 s; Insertion of composite resin Opus Bulk Fill inside the proximal walls up to the height of the pulp wall; Photoactivation for 20 s in the mesial and distal proximal box; Insertion of the Opus Bulk Fill composite resin inside the pulp wall up to a maximum height of 4 mm, measured using a good quality millimeter probe; Photoactivation for 20 s; insertion of Opus Bulk Fill resin up to the limit of the superficial cavity angle in the occlusal; Photoactivation f

Primary Outcome(s)

Difference in the quality of the resins used, based on the evaluation of the criteria for retention, coloration, staining, marginal adaptation, secondary caries, superficial texture, anatomical shape and post-operative sensitivity, in three classification stages - A (alpha - excellent); B (bravo - good); C (charlie - bad).

Secondary Outcome(s)

Difference in the impact of the patient's quality of life after the restorative procedure, assessed using the OHIP-14 questionnaire before and after the restorative procedure.

Source(s) of Monetary Support

Fundação de Amparo à Pesquisa e ao Desenvolvimento Científico e Tecnológico do Maranhão

Secondary Sponsor(s)

Universidade Ceuma