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Bulk fill composite resins

Bulk fill composite resins: randomized and double-blind clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-8fdnky
Enrollment
Unknown
Registered
2018-05-09
Start date
2017-09-02
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dentin Sensitivity

Interventions

E06.323.428
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 di
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 mo
Procedure/surgery

Sponsors

Departamento de Odontologia Restauradora da Universidade Federal do Ceará
Lead Sponsor
Departamento de Odontologia Restauradora da Universidade Federal do Ceará
Collaborator

Eligibility

Age
18 Years to 60 Years

Inclusion 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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Brazil

Contacts

Public ContactVicente de Paulo Saboia

Universidade Federal do Ceará

vpsaboia@yahoo.com+55 (85) 98807.4623

Outcome results

None listed

Source: REBEC (via WHO ICTRP)