B-OHIP14: Efficacy of Two Local Anesthetics on Quality of Life After Endodontic Treatment

Sponsor

NYU College of Dentistry (Other)

Overall Status

Suspended

CT.gov ID

NCT04787731

Collaborator

(none)

100

Enrollment

Location

Arms

38.1

Anticipated Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative Quality of Life	Drug: Bupivacaine Local Anesthetic	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Double blind randomized clinical trialDouble blind randomized clinical trial

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

Jul 29, 2019

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	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 Other Names: Lidocaine Local Anesthetic
Active Comparator: 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.	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 Other Names: Lidocaine Local Anesthetic

Arm

Intervention/Treatment

Active Comparator: 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.

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

Other Names:

Lidocaine Local Anesthetic

Active Comparator: 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.

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

Other Names:

Lidocaine Local Anesthetic

Outcome Measures

Primary Outcome Measures

Effects of Bupivacaine/Lidocaine will be assessed on post-operative pain intensity, medication use and length of numbness compared between the two study groups using Oral Health Related Quality-of-Life (OHQoL) questionnaire and Visual Analog Scale (VAS). [4 weeks +-10 days]
The OHQoL questionnaire contains 14 questions and scores can range from 0 to 56. Pain intensity is measured by VAS scale and scores can range from 0-10. Higher scores represent worse outcomes for both assessments.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Patients between the ages of 18-85 years
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:

Medically complex patients with severe systemic diseases (ASA III or above). These may include uncontrolled diabetes, uncontrolled blood pressure and/or chronic renal failure, for example, and potential participants will be asked about these conditions during the screening process.
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