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 @ 3:21 AM
Ignite Modification Date:
2025-12-25 @ 3:21 AM
NCT ID:
NCT03032705
Eligibility Criteria:
Inclusion Criteria:
* Is at least 18 years of age
* Is willing to provide voluntary written informed consent
* Is in good medical health and able to tolerate the dental procedures
* Has at least 1 pair of qualifying molars or premolars that require Class II restorations.
* Restorations must have a buccal to lingual/palatal width equal to or greater than 1/3 the distance from buccal to lingual/palatal cusp tips
* Study teeth must be in occlusal function and must also be in contact with the neighboring tooth on at least one surface
* Study teeth must be vital (i.e., free of clinical signs and symptoms of periapical pathology)
Exclusion Criteria:
* Is currently taking part in an evaluation of other dental restorative materials
* Has chronic periodontitis or rampant caries
* Teeth exhibiting clinical signs of periapical pathology
* Teeth with a history of self-reported preoperative pulpal problems
* Women who are pregnant (self-reported). It is standard of care to post-pone routine dental procedures and radiographed until after pregnancy.
* Women who are breast feeding.
* Known allergy to resin composites or local anesthetics.
* Abnormal oral soft tissue findings (e.g., open sores, lesions)
* An employee of the sponsor or members of their immediate family.
* Condition affecting salivary flow (e.g., salivary gland disorder, Sjögren's Syndrome)
* Any restorative treatment of the teeth involved in the study in the last 12 months.
* Are unwilling or unable to have dental radiographs or photographs taken of their dentition and soft tissues
* Any other condition which is the view of the investigator may affect the ability of a patient to complete the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03032705
Study Brief:
Protocol Section:
NCT03032705