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:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-26 @ 3:14 PM
NCT ID:
NCT07466095
Eligibility Criteria:
Inclusion Criteria:
* Male and female patients. Age between 14 years and 50 years . Diagnosis established in accordance with the American Association of Endodontists (AAE) (2013) for normal pulp, reversible pulpitis, or symptomatic irreversible pulpitis. Participants will be asked if they wish to be included in the study (implying informed consent).
Normal pulp Sound, unrestored non-carious vital teeth will be included. The teeth with healthy pulp. The teeth indicated for orthodontic extraction or elective root canal treatment before prosthodontic intervention.
There with no clinical signs or symptoms of pulpitis. There with no history of pain. The response to the cold test within normal limits. No sensitivity to percussion. No periodontal ligament space widening (Periapical Index (PAI) = 1). Teeth with Reversible Pulpitis \[RP\] Medically healthy patients will be included.
Patients with extremely deep carious lesion (according to Bjørndal, 2017) One or more of the following signs and symptoms present:
Clinical symptoms of minor intensity. Slightly exaggerated reaction to cold or sweet stimuli. No history of spontaneous pain. Response to the cold test within normal limits. No sensitivity to chewing. No sensitivity to percussion. No widening of the periodontal ligament space (Periapical Index (PAI) = 1). Teeth with Irreversible Pulpitis \[IRP\] Medically healthy patients will be included. Patients with extremely deep carious lesion
One or more of the following signs and symptoms were present:
History of continuous moderate or severe pain. Either provoked or spontaneous lingering pain initiated by provocation (cold test).
Tenderness to chewing or percussion. No widening of the periodontal ligament space (Periapical Index (PAI) = 1) (Orstavik,1988)
Exclusion Criteria:
* Absence of a response to pulp sensibility tests. Non-restorable teeth. Periodontal involvement. Presence of a sinus tract. Presence of periapical pathology on radiograph. Presence of resorption (external or internal). Cracked teeth. Immature teeth with an open apex. Presence of any systemic disease. Pregnant females. History of intake of Non-Steroidal Anti-inflammatory Drugs (NSAIDs) or antibiotics within the last 1 week.
Patients who needed prophylactic antibiotics. No pulp exposure after complete caries removal. Inadequate blood volume collection after pulpal exposure.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
14 Years
Maximum Age:
50 Years
Study:
NCT07466095
Study Brief:
Protocol Section:
NCT07466095