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 @ 9:24 PM
Ignite Modification Date:
2025-12-24 @ 9:24 PM
NCT ID:
NCT01728532
Eligibility Criteria:
Inclusion Criteria
* Male or female \>18 years old
* provide signed, informed consent.
* be affiliated to social security.
In addition, the subjects must fulfill all of the following criteria for root canal sealer treatment:
* Permanent mature single rooted teeth : maxillary incisors, mandibular incisor with only one canal, upper and lower canine, upper and lower premolars with only one canal
* Permanent mature mandibular molars Pulp status
* Vital pulp that needs pulpectomy without clinical and/or radiological findings of apical periodontitis.
* Irreversible pulpitis with or without pain
* Non infected tooth that positively responds of pulp vitality test Or necrotic pulp with and without radiographic signs of apical pathosis Periodontal status
* No active periodontal disease
Exclusion criteria:
* History of malignancy in the last 5 years.
* Systemic disease not stabilized within 1 month before the Inclusion Visit (e.g., diabetes, thyroid malfunction, uncontrolled autoimmune disease) or judged by the investigator to be incompatible with the study (e.g. current systemic infections) or condition incompatible with the frequent assessments needed by the study.
* Risk A cardiopathies
* Known hypersensitivity to one of the components of the study or procedural medications.
* Presence or history of severe systemic allergy.
* Presence or history of drug addiction or alcohol abuse.
* Patient who has participated in a clinical trial with a new active substance during the month before study entry.
* Participation in another clinical study at the same time as the present study.
* Known pregnancy or lactation at study entry.
* Patients with legal protection
Specific criteria relative to root canal sealing are:
* Extreme curvature of the canals
* Dilacerations
* Root dilacerations and sharp apical curvature for mandibular molars
* Superimposition of mesial canals for mandibular molar
* Large peri-apical radiolucencies
* Periodontal disease
* Not primary endodontic treatment
* Perforated root canals
* Supracrestal iatrogenic perforation
* Inadequate or insufficient periodontal support
* Combined endo-periodontal lesion
* Loss of tooth structure (Coronal decay and/or concomitant root decay) compromising the tooth's maintenance on the dental arch)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01728532
Study Brief:
Protocol Section:
NCT01728532