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 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 12:32 AM
NCT ID:
NCT02635867
Eligibility Criteria:
Inclusion Criteria:
Clinical inclusion criteria:
* Adults in good general health between 18 and 64 years of age;
* Active carious lesions deep into dentin (75% or more of dentin) involving occlusal/incisal and/or proximal surfaces of permanent teeth;
* Absence of clinical symptoms of irreversible pulpitis (spontaneous pain);
* Absence of periapical pathology, sinus tract, swelling or abnormal mobility;
* Restorable teeth.
Radiographic inclusion criteria:
* Extension of carious lesion close to potential exposure upon excavation (within the D3 region - lesion extending 2/3 within dentin); with the presence of a well-defined radiodense zone between the lesion and the pulp;
* Absence of periapical radiolucency;
* Absence of thickening of the periodontal ligament,
* Absence of resorptive defects.
Exclusion Criteria:
* Non restorable teeth;
* Teeth with:
* Recent trauma (within 6 months);
* Calcified root canals;
* Periapical radiolucency;
* Patients experiencing spontaneous moderate to severe pain;
* Patients that are pregnant or planning to become pregnant in the next year.
* Patients taking analgesics, anti-inflammatory, or antidepressant medications;
* Patients with orthodontic treatment;
* Newly erupted teeth.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT02635867
Study Brief:
Protocol Section:
NCT02635867