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 @ 6:49 PM
Ignite Modification Date:
2025-12-24 @ 6:49 PM
NCT ID:
NCT05496257
Eligibility Criteria:
Inclusion Criteria:
* 1\. Clinical:
1. Children categorized as class I or II according to American Society of Anaesthesiologists (ASA) scale.
2. Children rated as no. 3 or 4 in Frankl behaviour rating scale (FBRS).
3. Presence of a small carious or traumatic pulp exposure (1 mm or less). 2. Radiographic:
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1. Presence of at least two-thirds of root length.
2. Normal lamina dura and periodontal ligament space.
Exclusion Criteria:
* 1\. Clinical:
1. History of spontaneous unprovoked toothache.
2. Extensive crown destruction that preclude coronal restoration.
3. Gingival swelling, sinus tract or other soft tissue pathology.
4. Abnormal tooth mobility.
5. A frank pulp exposure (i.e., greater than 1.0mm), requiring pulpotomy.
6. No evidence of visible pulp exposure.
2\. Radiographic:
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1. Furcation/periapical radiolucency.
2. Pathological internal/external root resorption.
3. Absence of underlying permanent successor
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
6 Years
Study:
NCT05496257
Study Brief:
Protocol Section:
NCT05496257