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 @ 7:35 PM
Ignite Modification Date:
2025-12-24 @ 7:35 PM
NCT ID:
NCT06183203
Eligibility Criteria:
Inclusion Criteria:
1. Healthy (ASA I and II) co-operative children (Frankl Scale + and ++) between the ages of four and nine years.
2. Participants have symptoms typical of irreversible pulpitis in one of the primary molars.
3. The pulp of the affected primary molar is vital.
4. Radicular pulp health is confirmed by attainment of radicular pulp haemostasis within 8 minutes of coronal pulp amputation.
5. The affected primary molars can be restored with full coverage crowns.
6. Any physiologic root resorption, if present, is less than ⅓ the root length
Exclusion Criteria:
1. Clinical examination of affected primary molar reveals signs of pulpal infection (e.g.
pathologic tooth mobility, parulis/fistula, or soft tissue swelling)
2. Pre-operative periapical radiograph suggests presence of periapical radiolucency.
3. Pre-operative periapical radiograph suggests presence of furcal radiolucency more than ½ the furcation to periapical area.
4. Visual examination of pulp tissue after deroofing reveals signs of necrosis (e.g. avascular/minimally bleeding pulp tissue or yellowish necrotic areas/purulent exudate).
5. Signs of extensive radicular pulp inflammation.
6. Parents not willing to place full coverage crowns post-treatment.
7. Clinical diagnosis of irreversible pulpitis between two primary molars is not sharply defined
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
9 Years
Study:
NCT06183203
Study Brief:
Protocol Section:
NCT06183203