Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2025-12-25 @ 2:27 AM
NCT ID:
NCT01369134
Eligibility Criteria:
Inclusion Criteria:
* 18 years or older
* written informed consent
* regular dental attender, can return to clinic for study recalls
* good medical health
* normal saliva flow
* has one or two pairs of back teeth that require a Class I or II restoration of appropriate size
* study teeth that are vital
Exclusion Criteria:
* currently in an evaluation of other dental materials
* an irregular dental attender
* has unacceptable oral hygiene standards
* has chronic periodontitis or rampant caries
* has teeth with signs of periapical pathology
* has history of pulp problems, and/or needs pulp treatment
* women who are pregnant or breast-feeding
* has known allergy to resin composite or latex
* has serious chronic disease requiring hospitalization
* has oral soft tissue pathologies
* takes medications which, in the opinion of the investigator, could interfere with the conduct of the study
* has current or recent history of alcohol or other substance abuse
* is an employee of the sponsor or the study site, or members of their immediate family
* has had any restorative treatment of teeth involved in the study in the last twelve months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01369134
Study Brief:
Protocol Section:
NCT01369134