Bulk fill composite resins

• Register: REBEC
• Last refreshed on: 29 May 2023
• Main ID: RBR-8fdnky
• Date of registration: 09/05/2018
• Prospective Registration: No
• Primary sponsor: Departamento de Odontologia Restauradora da Universidade Federal do Ceará
• Public title: Bulk fill composite resins
• Scientific title: Bulk fill composite resins: randomized and double-blind clinical trial
• Date of first enrolment: 02/09/2017
• Recruitment status: Recruiting
• URL: http://ensaiosclinicos.gov.br/rg/RBR-8fdnky
• Study type: Intervention
• Study design: Clinical trial of treatment, randomized ,; controlled, parallel , double-blind, arms 5
• Phase: N/A

Countries of recruitment

Brazil

Contacts

• Name: Vicente de Paulo Aragão Saboia
• Affiliation: Universidade Federal do Ceará

• Name: Nara Sousa Rodrigues
• Affiliation: Universidade Federal do Ceará

Key inclusion & exclusion criteria

Inclusion criteria: All included patients will require at least five class I or II restorations in molars or premolars. The causes for composite resin restorations in this study may be fractures, large misalignments or other defects in existing amalgam restorations, or replacement of amalgam restorations for aesthetic reasons. In that case, the request must be made by the patient. Patients must be at least 18 years. Patients should have good general health, acceptable oral hygiene and availability of return during the evaluation periods. All teeth included in the study should have a normal occlusal relationship with the natural antagonist tooth, at least one contact with the adjacent tooth and those with marked occlusal stress, evidenced by severe occlusal wear, will be excluded. The cavities may involve enamel and dentin and should have a minimum depth of 3 mm.
Exclusion criteria: Pregnancy or breastfeeding, non-vital tooth, allergies and idiosyncratic responses to product ingredients, occlusal contactless tooth with or without proximal contact, orthodontic treatment for less than 3 months, history of existing tooth sensitivity, prosthetic teeth fixed or removable, periodontal surgery performed less than 3 months ago, teeth or supporting structures with any painful pathology, bruxism, periodontal disease, known allergy to resinous materials, cavities to be restored shallow and / or narrow, impossibility to return to the recalls , fractured or visibly cracked teeth.

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

Health Condition(s) or Problem(s) studied

Dentin Sensitivity

C07.793.266

Intervention(s)

Forty-five individuals requiring at least 5 class I and / or II restorations in premolars and molars of similar size will be selected. The teeth will be divided into five groups (n=45) and randomly distributed according to the restorative materials (adhesive system vs. composite resin): G1: Single Bond Universal + Z350XT; G2: Single Bond Universal + Filtek Bulk Fill; G3: OptiBond All-in-One + Premise; G4: OptiBond All-in-One + SonicFill; G5: Amber Universal + Opus Bulk Fill. The restorations will be performed in the same office visit and all patients will be evaluated after the final polishing and in the periods of 6, 12, 24 and 36 months, using the criteria of the International Dental Federation (FDI). The spontaneous postoperative sensitivity will be evaluated in the periods of 24 h, 7 and 30 days, using the numerical classification scale of 0-4 and the visual analogue scale of 0-10 and 0-100.

Procedure/surgery

D05.750.716.822.308

E06.323.428

Primary Outcome(s)

Postoperative Sensitivity: For this evaluation, participants will be questioned about spontaneous post-operative sensitivity using the numerical rating scale of 0-4 (0 = absent, 1 = mild, 2 = moderate, 3 = considerable, 4 = severe) and the visual analogue scale (VAS) of 0-10 and 0-100 after 24 h, 7 and 30 days. The restorations will also be evaluated clinically after the final polishing (one week) and in the periods of 6, 12, 24 and 36 months.

Secondary Outcome(s)

Retention: Evaluation through visual
inspection with explorer and mirror in
periods of 6, 12, 24 and 36 months.
Will be classified as: retained ou missing.

Marginal adaptation: Evaluation through
visual inspection with explorer and mirror, if
necessary, in periods of 6, 12, 24 and 36
months.
Will be classified as: Restoration is
continuous with existing anatomic form,
detectable defect in enamel only
(catches explorer going both ways) or
detectable defect to
dentinenamel junction

Marginal staining: Evaluation through visual
inspection with mirror, in periods of 6, 12,
24 and 36 months.
Will be classified as: no discoloration along
the shore, light and superficial staining
(removable and usually located) or deep
pigmentation that can not be removed by
polishing.

Secondary caries: Evaluation through
visual inspection with mirror and explorer, in
periods of 6, 12, 24 and 36 months.
It will be classified as: No evidence of
caries contiguous with the margin or
evidence of the presence of caries.

Source(s) of Monetary Support

Departamento de Odontologia Restauradora da Universidade Federal do Ceará

Secondary Sponsor(s)

Departamento de Odontologia Restauradora da Universidade Federal do Ceará