Efficacy of Two Local Anesthetics on Quality of Life After Endodontic Treatment
NCT ID: NCT04787731
Last Updated: 2023-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
PHASE4
100 participants
INTERVENTIONAL
2019-07-29
2024-10-01
Brief Summary
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Subjects' oral health related quality of life and postoperative pain resolution, pain medication use and numbness will be compared in two study groups.
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Detailed Description
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After screening for eligibility based on the inclusion and exclusion criteria listed below, and after preoperative data collection, in the experimental arm, inferior alveolar nerve block (IANB) will be administered 0.5% bupivacaine with 1:200,000 epinephrine whereas in the control arm, IANB will be administered 2% lidocaine with 1:100,000 epinephrine for a standardized pulpectomy/endodontic debridement treatment as the 1st visit endodontic treatment for subjects with preoperative pain. Postoperative oral health related quality of life questionnaire (OHIP-14) responses at day 1 and 5 as well as 5-day postoperative pain intensity questionnaire will be collected remotely. In this way, we will be able to compare OHQoL change as well as postoperative pain resolution, pain medication use and postoperative soft tissue anesthesia reported by the patient in two study arms.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
TRIPLE
Study Groups
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Lidocaine
Lidocaine HCI (1.7mL) 2% concentration with epinephrine (1:100,000) is the control agent. It exists in liquid form in cartridges. Lidocaine is a FDA approved marketed anesthetic drug.
Bupivacaine Local Anesthetic
Long lasting local anesthetic administered to be compared to Lidocaine for quality of life outcomes in dental patients undergoing endodontic treatment
Bupivacaine
Bupivacaine HCI (1.8mL) 5% concentration, with epinephrine (1:200,000) is the investigational product. It exists in liquid form in cartridges. Bupivacaine is a FDA approved marketed anesthetic drug and meets IND Exemption.
Bupivacaine Local Anesthetic
Long lasting local anesthetic administered to be compared to Lidocaine for quality of life outcomes in dental patients undergoing endodontic treatment
Interventions
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Bupivacaine Local Anesthetic
Long lasting local anesthetic administered to be compared to Lidocaine for quality of life outcomes in dental patients undergoing endodontic treatment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with pulpal diagnosis of either symptomatic irreversible pulpitis or pulp necrosis and periapical diagnosis of normal apical tissues, symptomatic apical periodontitis or asymptomatic apical periodontitis.
* Patients who only have one tooth with odontogenic pain at the time point of the screening.
* Patients who are treatment planned, and have agreed to have, pulpectomy/endodontic debridement.
* Patients with acute dental pain of at least 3/10 on NRS
* Patients must be able to comprehend and complete all study questionnaires
* Patients must be able to comprehend the description of the study protocol and written consent Patients must be able to be contacted by text messages, phone calls or email during 5 days after pulpectomy/endodontic debridement
Exclusion Criteria
* Pregnant Patients
* Patients who have already been enrolled in the study. Patients can only be enrolled for treatment on one tooth.
* Patients with known hypersensitivity or allergy to any local anesthetic agent of the amide group, or any other components of the two anesthetic solutions such as epinephrine, sodium metabisulfite used in the study.
* Patients who use ergot-type oxytocic drugs for uterine contraction, monoamine oxidase inhibitors, antidepressant of triptyline or imipramine types or patients who are planned to receive sedatives for the treatment.
* Patients with additional elective dental treatments like extraction, implant placement, root canal therapy planned in the 5 days following the date of enrollment in this study
* Patients with pain whose examined tooth is planned for vital pulp therapies e.g. pulpotomy, retreatment, apical surgery or extraction
* Patients with a pulpal diagnosis or reversible pulpitis, previously treated, previously initiated therapy and periapical diagnosis of acute apical abscess or chronic apical abscess.
* Patients who have multiple teeth with odontogenic pain at the time of the screening
* Patients who do not understand or are able to read the questionnaires
* Non-English speaking patients
18 Years
85 Years
ALL
Yes
Sponsors
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NYU College of Dentistry
OTHER
Responsible Party
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Asgeir Sigurdsson, DDS, MS
Professor and Chair Department of Endodontics
Principal Investigators
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Asgeir Sigurdsson
Role: PRINCIPAL_INVESTIGATOR
NYU Dentistry
Locations
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NYU College of Dentistry
New York, New York, United States
Countries
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References
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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s19-00069
Identifier Type: -
Identifier Source: org_study_id
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