NCT04787731

Efficacy of Two Local Anesthetics on Quality of Life After Endodontic Treatment

Efficacy of Two Dental Local Anesthetics on the Oral Health-Related Quality of Life After Endodontic Treatment in the Symptomatic Mandibular Molars: A Double Blind Randomized Controlled Trial

• Status: Suspended
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: NYU College of Dentistry · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

In this randomized controlled double-blinded study, subjects will be assigned to one of two study groups to either be anesthetized with Bupivacaine or Lidocaine prior to needed treatment of pulpectomy/endodontic debridement on a symptomatic tooth. Subjects' oral health related quality of life and postoperative pain resolution, pain medication use and numbness will be compared in two study groups.

Detailed description

This is a double-blind randomized controlled single-site trial. We aim to recruit 100 subject, with an anticipated dropout rate of 20%; our goal is to enroll 40 subjects in each study arm based on the power analysis described in data analysis section as well as general feasibility for recruitment, and the ability to complete the study in within one year. 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

• Pain, Postoperative
• Quality of Life

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-07-29
• Primary completion: 2024-10-01
• Completion: 2024-10-01
• First posted: 2021-03-09
• Last updated: 2023-11-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study