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 @ 1:47 AM
Ignite Modification Date:
2025-12-25 @ 1:47 AM
NCT ID:
NCT03624894
Eligibility Criteria:
Inclusion Criteria:
1. Subject ≥18 years.
2. Subjects with restorative treatments on vital teeth in posterior molar region. Will be considered at most one reconstruction per side.
3. Restorations limited to two surfaces (Black's Class II) with one proximal cavity, in occlusion. Max 1 restoration will be included each oral side (right or left).
4. Favorable and stable occlusal relationship between the remaining teeth.
5. Subject must be reliable, cooperative, and in the opinion of the Investigator, likely to be compliant with study procedures.
6. Subject provides written informed consent signed and dated prior to entering the study.
Exclusion Criteria:
Inclusion and exclusion criteria
Inclusion criteria
1. Subject ≥18 years.
2. Subjects with restorative treatments on vital teeth in posterior molar region. Will be considered at most one reconstruction per side.
3. Restorations limited to two surfaces (Black's Class II) with one proximal cavity, in occlusion. Max 1 restoration will be included each oral side (right or left).
4. Favorable and stable occlusal relationship between the remaining teeth.
5. Subject must be reliable, cooperative, and in the opinion of the Investigator, likely to be compliant with study procedures.
6. Subject provides written informed consent signed and dated prior to entering the study.
Exclusion criteria
1. Subject with full dentures or crowns and bridges in occlusal contact with teeth indicated for restorative treatment.
2. Absence of occlusal contact.
3. Subject has a history of drug abuse, addiction to medication or alcohol abuse within the previous year.
4. Pulp exposure during restorative procedure or unvital teeth.
5. Known unavailability of subject for recall Visit(s).
6. Allergy to any ingredient of impression material.
7. Severe bruxism.
8. Subject with clinically significant or unstable medical or physiological condition.
9. Female subject is pregnant or lactating or intends to become pregnant during the course of the study.
10. Subject is not willing to participate in the study or not able to understand the content of the study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03624894
Study Brief:
Protocol Section:
NCT03624894