Status:
COMPLETED
Efficacy of Lidocaine and Xylometazoline Intranasal Spray in Anesthetizing Maxillary Teeth
Lead Sponsor:
Dow University of Health Sciences
Conditions:
Effect of Drug
Eligibility:
All Genders
18-40 years
Phase:
EARLY_PHASE1
Brief Summary
Different anesthetic techniques are used for achieving pulpal anesthesia of maxillary teeth. Recently tetracaine and oxymetazoline were used as local anesthetic agents in the form of an intranasal spr...
Detailed Description
Different anesthetic techniques are used for achieving pulpal anesthesia of maxillary teeth. The most commonly used technique is the infiltration anesthesia that currently is the gold standard. Howeve...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
July 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 14 2020
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04732104
Start Date
July 20 2018
End Date
August 14 2020
Last Update
February 1 2021
Active Locations (1)
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1
Dow University of Health Sciences
Karachi, Sindh, Pakistan