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Clinical Trials/DRKS00031499
DRKS00031499
Recruiting
未知

Clinical performance evaluation of nanocomposite resin materials in anterior restorations - Filtek anterior

3M Deutschland GmbH0 sites190 target enrollmentApril 26, 2023

Overview

Phase
未知
Intervention
Not specified
Conditions
K02.9
Sponsor
3M Deutschland GmbH
Enrollment
190
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 26, 2023
End Date
TBD
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • 1\. Subject is at least 18 years or older at time of consent.
  • 2\. Subject and the subject’s legally designated representative (if applicable) is able to provide their own informed consent.
  • 3\. Subject is willing to return for follow\-up examination for at least 2 years
  • 4\. Subject needs at least either one class III or one class IV restoration
  • 5\. Subjects study teeth must have a good prognosis for the next 3 years (e.g., no increased tooth mobility, periodontal probing depth is \=5 mm, no signs of pulpitis, no pulp exposure during treatment, study teeth are vital, level of oral hygiene is sufficient with PBI \= 30%)
  • 6\. Subject meets the Level\-I or Level\-II classification criteria of the American Society of Anesthesiologists (ASA) Physical Status Classification System For Dental Patient Care

Exclusion Criteria

  • 1\. Subjects tooth needs a repair of an already existing class III or class IV restoration
  • 2\. Subject has a known allergies to acrylate\-based materials
  • 3\. Subject is enrolled in another clinical trial at the time of screening that would interfere with this study
  • 4\. Subject is experiencing sensitivity and pain of affected tooth
  • 5\. Pulpal exposure of tooth
  • 6\. Subject undergoing any orthodontic treatment
  • 7\. Subject is, in the opinion of the Investigator, unsuitable for enrollment in this study for reasons not specified in the exclusion criteria (e.g., acid erosion or dietary concerns, severe bruxism with loss of vertical height)
  • 8\.Subject cannot withhold the use of bleaching or tooth whitening products besides whitening toothpaste (e.g. carbamide peroxide or hydrogen peroxide gels, strips, trays, or in\-office bleaching) during the study period

Outcomes

Primary Outcomes

Not specified

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