Evaluation of restorations using bulk fill ormocer based composite

• Register: REBEC
• Last refreshed on: 29 May 2023
• Main ID: RBR-6mvp9w
• Date of registration: 20/08/2019
• Prospective Registration: No
• Primary sponsor: Instituto de Ciência e Tecnologia da Universidade Estadual Paulista de São José dos Campos
• Public title: Evaluation of restorations using bulk fill ormocer based composite
• Scientific title: Clinical evaluation of restorations in posterior teeth using bulk fill ormocer composite - a randomized clinical trial
• Date of first enrolment: 01/08/2018
• Recruitment status: Recruiting
• URL: http://ensaiosclinicos.gov.br/rg/RBR-6mvp9w
• Study type: Intervention
• Study design: Treatment, parallel, two-arms, double-blind, randomized controlled clinical trial
• Phase: N/A

Countries of recruitment

Brazil

Contacts

• Name: Carlos Rocha Gomes Torres
• Affiliation: Instituto de Ciência e Tecnologia da Universidade Estadual Paulista de São José dos Campos

• Name: Carlos Rocha Gomes Torres
• Affiliation: Instituto de Ciência e Tecnologia da Universidade Estadual Paulista de São José dos Campos

Key inclusion & exclusion criteria

Inclusion criteria: Age between 18 and 70 years; presence of antagonist tooth; vital pulp and no painful sensation; no previous pulp caping; no previous report of sensitivity; istmus smaller than 2/3 of intercuspal distance; permanent teeth; good horal hygine and no periodontal disease; no sistemic disease; no removable prosthesis resting on the restored tooth.

Exclusion criteria: Parafunctional habits; large caries lesions; pulpal exposure during the preparation; high risk of pulp exposure; pontaneous pain or after percussion.


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

Health Condition(s) or Problem(s) studied

Dental Caries

Intervention(s)

E06.323.428

A total of 30 patients will participate of the study, and each will receive two differente restoration, in a split mouth design.

The aim of this study will be to evaluate the clinical behavior of composite restorations in posterior teeth made with a conventional and a bulk fill Ormocer based composites. Thirty patients will be selected and receive two restorations each one, using a split-mouth design. The control restoration will be performed using a conventional viscosity and translucency composite (Admira Fusion, Voco), applied through a layering technique, with 2mm thick oblique increments. The experimental restoration will be performed using a flowable bulk fill composite (Admira Fusion X-base, Voco). This material will be applied using a 4mm thick horizontal layer, being light-cured and covered with the conventional composite. For all restorations the self-etch adhesive system Futurabon U will be applied. The randomization about each tooth will receive the selected restorative material will be performed through an online softwate (https://www.sealedenvelope.com/). The operator will not be blinded in relation to the material applied, while the examiners and patients will be blinded. The restorations will be evaluation according the FDI criteria, analyzing the esthetic, biological and functional properties after 1 week, 6 months, 1 year and 2 years.

Other

Primary Outcome(s)

Expected outcome 1 - To evaluate the occurrence fractures or retention loss of the restorations, evaluated by visual direct clinical observation, probing and radiographic examination

Secondary Outcome(s)

Expected outcome 11 - To evaluate the occurrence of secondary caries on restorations margins, evaluated by visual clinical examination, probing of the margins and radiographic examination

Expected outcome 6 - To evaluate changes on anatomical form esthetic of the restoration, evaluated by visual direct clinical observation

Expected outcome 10 - To evaluate the occurrence of post-operative sensitivity, evaluated by anamnesis

Expected outcome 8 - To evaluate occlusal contour and wear of the restoration, evaluated by visual direct clinical observation, impression and indirect analysis of epoxy replicas

Expected outcome 12 - To evaluate the tooth integrity, evaluated by visual clinical examination

Expected outcome 13 - To evaluate the periodontal response around the restoration, evaluated by visual clinical examination and periodontal probing of the crevice

Expected outcome 3 - To evaluate the surface staining of the restorations, evaluated by visual direct clinical observation

Expected outcome 2 - To evaluate the changes on the surface brightness of the restorations, evaluated by visual direct clinical observation

Expected outcome 14 - To evaluate the general health of the patient, evaluated by clinical examination and anamnesis

Expected outcome 4 - To evaluate the marginal staining of the restorations, evaluated by visual direct clinical observation

Expected outcome 5 - To evaluate changes on color and translucency match between the restoration and the remaining tooth structure, evaluated by visual direct clinical observation

Expected outcome 7 - To evaluate occurrence of defects on the marginal adaptation of the restoration, evaluated by visual direct clinical observation and probing of the restoration margins with standardized probes

Expected outcome 9 - To evaluate the proximal contact of the restoration with the neighbor tooth, evaluated by standardized metal blades

Source(s) of Monetary Support

Instituto de Ciência e Tecnologia da Universidade Estadual Paulista de São José dos Campos

Secondary Sponsor(s)

Instituto de Ciência e Tecnologia da Universidade Estadual Paulista de São José dos Campos