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:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2025-12-24 @ 10:56 PM
NCT ID:
NCT03153969
Eligibility Criteria:
Inclusion Criteria:
* 18 years or older, in general health
* Must have a minimum of 2 cervical lesions in need of restoration
* Cervical lesions must provide for a minimum of 1mm thickness of restorative material while maintaining natural tooth contour
* At least 50% of lesion must be in dentin
* Coronal margin of lesion must be in enamel
Exclusion Criteria:
* Rampant uncontrolled caries
* Systemic or local disorders that contra-indicate the dental procedures included in this study
* Evidence of xerostomia
* Evidence of severe bruxing or clenching or in need of TMJ related therapy
* Women who are pregnant or breast feeding (self-reported).
* Known allergy to resin composites or local anesthetics
* Abnormal oral soft tissue findings (e.g., open sores, lesions)
* Condition affecting salivary flow (e.g., salivary gland disorder, Sjögren's Syndrome)
* Teeth with periapical pathology or exhibiting symptoms of pulpal pathology
* Teeth that are non-vital or have had root canal therapy
* Teeth that have been pulp capped
* Teeth with near exposures on pre-operative radiographs
* Hypersensitive teeth
* Teeth with a periodontal pocket of more than 4mm with bleeding on probing
* Teeth that are used as abutments for removable partial dentures
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03153969
Study Brief:
Protocol Section:
NCT03153969