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Evaluation of new material for teeth restorations: clinical trial

Clinical evaluation of a novel composite resin in posterior teeth: a double-blind, randomized, clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-255jzz9
Enrollment
Unknown
Registered
2023-07-14
Start date
2023-04-03
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

Dental Caries

Interventions

The main outcome of the study is fracture and retention of the restoration. The failure rate (fracture) after 5 years of clinical service of composite resin restorations in posterior teeth is 5% accor

Sponsors

Universidade Estadual de Ponta Grossa
Lead Sponsor
Universidade Estadual de Ponta Grossa
Collaborator

Eligibility

Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Healthy participants; of both genders; with an acceptable level of oral hygiene; of both genders; age between 18 and 60; present at least 20 teeth in occlusion; each participant must require at least three Class I or Class II restorations on vital teeth that are similar in horizontal and vertical dimensions; agree and sign the Informed Consent Form

Exclusion criteria

Exclusion criteria: Participants with extremely poor oral hygiene; with chronic or severe periodontitis (teeth with probing pocket depth greater than 4 mm with bleeding on probing and clinical attachment loss greater than 3 mm in more than 4 teeth); with the use of orthodontic appliances; with more than 10 teeth with occlusal wear (premolars and molars); with a known allergy to resin-based materials or any other material used in this study; pregnant or lactating women; using anti-inflammatories or analgesics or psychotropic drugs

Design outcomes

Primary

MeasureTime frame
To clinically evaluate the performance retention rate of a new self-curing composite resin in capsule or syringe presentation, at baseline and after 1, 2, 3, 4, and 5 years, when compared to a conventional composite resin. They will be evaluated using the criteria of the World Dental Federation (FDI).

Secondary

MeasureTime frame
Avaliar clinicamente o desempenho de uma nova resina composta autopolimerizável na apresentação de cápsulas ou em seringa, no baseline e após 1, 2, 3, 4 e 5 anos, quando comparada com uma resina composta convencional. Serão avaliadas utilizando os critérios da World Dental Federation (FDI).;Assess immediate postoperative sensitivity using the Visual Analog Scale (VAS; 0 - 10) and the Numerical Rating Scale (NRS; 0 - 4). Data will be presented with mean and standard deviation.

Countries

Brazil

Contacts

Public ContactRomina Ñaupari Villasante

Universidade Estadual de Ponta Grossa

rnauparivillasante@gmail.com+55-042-3220-3740

Outcome results

None listed

Source: REBEC (via WHO ICTRP)