Evaluation of new material for teeth restorations: clinical trial

Not Applicable

Recruiting

• Conditions: Dental Caries; C07.793

• Registration Number: RBR-255jzz9
• Lead Sponsor: niversidade Estadual de Ponta Grossa

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-07-14
• Last Update Posted: 26 July 2023
• Study Completion: 2028-11-21

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

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

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

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.