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 @ 7:51 PM
Ignite Modification Date:
2025-12-24 @ 7:51 PM
NCT ID:
NCT04732104
Eligibility Criteria:
INCLUSION CRITERIA
* Adults aged 18-40 years,
* Patients having a vital maxillary premolar, canine or incisor.
* Patients having Class 1,2,3,4 or 5 restorations (G.V. Black).95
* Patients having heart rate between 55 and 100 beats per min.
* Patients with a seated Systolic blood pressure between 95 and 150 mm Hg and diastolic blood pressure between 60 and 100 mm of Hg. (Although short-term use of topical alpha-2 agonists like xylometazoline has no systemic toxicity and are available as over the counter drugs but long-term abuse has been reported to cause systemic vasoconstriction and cardiovascular complications like hypertensive crisis therefore the cut off limit has been selected for blood pressure).
* Teeth with no radiographic evidence of pulpal or periapical pathosis.
* Patients having ICDAS caries detection score of 4, 5 or 6.
* Patients who fulfilled alcohol sniff test criterion.
EXCLUSION CRITERIA
* Patients with Upper respiratory tract infection.
* Patients with Uncontrolled thyroid disease.
* Patients having a known allergy to any of the components used in the solution.
* Pregnant or breast feeding patients.
* Those patients having 5 or more nosebleeds per month.
* Patients who received any local anesthetic/analgesic within 24 hours of study drug administration.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT04732104
Study Brief:
Protocol Section:
NCT04732104