Status:
TERMINATED
Combination of Buffered Anesthetic to Treat Mandibular Molars
Lead Sponsor:
Indiana University
Conditions:
Symptomatic Irreversible Pulpitis
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine whether a combination of anesthetics (numbing medicine) will adequately anesthetize teeth over a different combination. A second purpose is to see if the time...
Detailed Description
60 human subjects with Symptomatic Irreversible Pulpitis (SIP) in mandibular molars will be randomly allocated into 2 groups. One group will receive a combination of: 1 cartridge of buffered 2% lidoca...
Eligibility Criteria
Inclusion
- Be between the ages of 18 and 80 years old
- Have the ability and willingness to independently consent to treatment and study participation
- Have an uncomplicated medical history (ASA I and II)
- Not be pregnant
- Have no allergies local anesthetics/sulfites (confirmed or self-reported)
- Not be taking any medications that may affect the proper assessment of the anesthetic (no acetaminophen or short-acting NSAIDs such as ibuprofen within the previous 6 hours; no long-acting NSAIDs such as naproxen within the previous 16 hours)
- Not require nitrous oxide during treatment, and the injection area should appear healthy with no other pre-existing conditions or infections that may compromise an accurate collection of data
- Be experiencing signs of irreversible pulpitis (an exaggerated response to cold that lingers longer than 10 seconds) in a mandibular molar at the time of conducting the study
Exclusion
- A negative response to cold in the proposed treatment tooth
- A radiographic periradicular pathosis more advanced than a widened periodontal ligament or have an intraoral swelling
Key Trial Info
Start Date :
December 5 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 15 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06047366
Start Date
December 5 2023
End Date
May 15 2024
Last Update
May 13 2025
Active Locations (1)
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1
ndiana University School of Dentistry Graduate Endodontics Dept.
Indianapolis, Indiana, United States, 46202