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 @ 2:11 AM
Ignite Modification Date:
2025-12-25 @ 2:11 AM
NCT ID:
NCT03221660
Eligibility Criteria:
Inclusion Criteria:
* Indication for direct filling of Class I or II with permanent premolars or permanent molars
* replacement of insufficient fillings (e.g., due to edge caries, filling fracture, Lack of quality of the surface, lack of aesthetics, undesirable filling material, leaky edge, edge gap, etc.)
* extensive primary caries
* Vital tooth (cold test)
* One-, two- or three-surface fillings in the lateral tooth area, with a maximum of 25% single-faced (Class I) with antagonists.
* The occlusal area of the filling must be at least 1/3 of the total area of the filling tooth. This criterion is estimated.
* Patient wishes to receive care within the framework of the study (written consent after detailed elucidation and study of patient information).
* Maximum of 2 restorations per patient.
* Preoperative complaints on the tooth to be restored (maximum 3 on visual Analog scale (0 = complaint-free, 10 = maximum possible pain) to temperature or bite sensitivity
* Sufficient language skills
Exclusion Criteria:
* Unfinished hygiene phase or poor oral hygiene
* Sufficient draining of the operating field is not possible
* Patients with proven allergy to one of the ingredients of the materials used
* Patient has allergies to local anesthetic agents Ultracain DS (active substance: articaine; Vasoconstrictor), if anesthesia is desired
* Patients with severe systemic diseases
* Devital or pulpitic teeth
* Periodontal insufficiency
* Supplements with cusp attachments
* open side bite
* missing antagonist
* Indication for direct capping
* Pregnancy (women of childbearing age receive a free pregnancy test for self application, the negative result of which is shown with her confirmed consent).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03221660
Study Brief:
Protocol Section:
NCT03221660