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 @ 10:34 PM
Ignite Modification Date:
2025-12-24 @ 10:34 PM
NCT ID:
NCT02889835
Eligibility Criteria:
Inclusion Criteria:
* must have given written informed consent to participate in the trial
* must need at least three posterior dental fillings
* replacement restorations due to caries or an esthetic replacement with or without caries are acceptable.
* must be available for the required post-operative follow-up visits
* restorations must be in contact with opposing natural or crowned teeth with at least at least one occlusal contact in habitual closure
* Class II restorations must have at least one proximal contact
* restorations must have a buccal to lingual/palatal width no greater than 1/3 the distance from buccal to lingual/palatal cusp tips
* all restorations must Class II with a proximal contact with a natural or artificial tooth
Exclusion Criteria:
* have severe medical complications (organ transplants, long term antibiotic or steroid treatment, cancer or immunocompromised) and disabilities who may not be able to tolerate the time required to complete the restorations or to provide adequate oral hygiene
* have xerostomia either by taking medications known to produce xerostomia or those with radiation induced or Sjogren's syndrome patients
* have chronic periodontitis, rampant caries or poor oral hygiene which may require extraction of the teeth to be restored
* are unavailable for long term recall
* cannot tolerate the rubber dam required for isolation of the tooth during preparation and restoration.
* do not meet all inclusion criteria
* present with any systemic or local disorders that contra-indicate the dental procedures included in this study
* have an unstable occlusion
* have severe bruxing or clenching or in need of TMJ related therapy
* have teeth with periapical pathology or expected pulp exposures
* have teeth that are non-vital or that exhibit signs of pulpal pathology
* are pregnant.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
90 Years
Study:
NCT02889835
Study Brief:
Protocol Section:
NCT02889835