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 @ 11:09 PM
Ignite Modification Date:
2025-12-24 @ 11:09 PM
NCT ID:
NCT04966169
Eligibility Criteria:
Inclusion Criteria:
* Age 18+ years
* Speak and Read English
* Able to attend follow-up visits at 6 months AND 1 year (post-baseline treatment)
* A tooth with no response to cold and electric pulp testing.
* Tooth is a 1st or 2nd mandibular molar
* Tooth has no response to cold/electric pulp testing
* Tooth has a diagnosis of pulp necrosis with asymptomatic apical periodontitis
* 1st and 2nd mandibular molars.
* Current (i.e., taken within the last week) radiograph available (or done at screening, as needed)
* A limited-volume, cone-beam computed tomography (CBCT) taken at the first visit confirms apical periodontitis (radiolucency).
Exclusion Criteria:
* Patient has advanced untreated periodontal disease/recent periodontal surgery
* Patient has non-odontogenic facial pan (e.g., face pain of unknown cause)
* Patient has a history of poor attendance at dental visits
* Patient is pregnant
* Patient reports taking corticosteroids
* Patient is supervised by the Principal Investigator or a member of the research team
* Patient is subordinate to the Principal Investigator or a member of the research team
* Patient is a student/trainee under the direction of the Principal Investigator or a member of the research team
* Tooth had previous intervention (e.g., pulp debridement: removal of the pulp/nerve of the tooth)
* Tooth has incomplete root formation (e.g., immature with apical periodontitis)
* Tooth has defective restorations or carious lesions (i.e., cavities) that could lead to microleakage
* Tooth has internal or external resorption
* Tooth has a mobility score of 3
* Tooth has a fracture/visibly cracked
* Tooth has vital (i.e., functioning) pulp
* Advanced untreated periodontal disease or recent periodontal surgery.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT04966169
Study Brief:
Protocol Section:
NCT04966169