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

NCT04787731 | Suspended Phase 4 DMC FDA Drug

• 1 other identifier: s19-00069
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative; Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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).

  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.

  4 weeks +-10 days

Study Arms (2)

Lidocaine

ACTIVE COMPARATOR

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

Bupivacaine

ACTIVE COMPARATOR

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

Interventions

Bupivacaine Local Anesthetic DRUG

Long lasting local anesthetic administered to be compared to Lidocaine for quality of life outcomes in dental patients undergoing endodontic treatment

Also known as: Lidocaine Local Anesthetic

Bupivacaine; Lidocaine

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU College of Dentistry: lead

Study Sites (1)

NYU College of Dentistry

New York, New York, 10010, United States

Location

Related Publications (27)

• Pak JG, White SN. Pain prevalence and severity before, during, and after root canal treatment: a systematic review. J Endod. 2011 Apr;37(4):429-38. doi: 10.1016/j.joen.2010.12.016.

  PMID: 21419285 BACKGROUND

• Arias A, de la Macorra JC, Hidalgo JJ, Azabal M. Predictive models of pain following root canal treatment: a prospective clinical study. Int Endod J. 2013 Aug;46(8):784-93. doi: 10.1111/iej.12059. Epub 2013 Feb 12.

  PMID: 23402273 BACKGROUND

• Law AS, Nixdorf DR, Aguirre AM, Reams GJ, Tortomasi AJ, Manne BD, Harris DR; National Dental PBRN Collaborative Group. Predicting severe pain after root canal therapy in the National Dental PBRN. J Dent Res. 2015 Mar;94(3 Suppl):37S-43S. doi: 10.1177/0022034514555144. Epub 2014 Oct 29.

  PMID: 25355775 BACKGROUND

• Rechenberg DK, Held U, Burgstaller JM, Bosch G, Attin T. Pain levels and typical symptoms of acute endodontic infections: a prospective, observational study. BMC Oral Health. 2016 May 27;16(1):61. doi: 10.1186/s12903-016-0222-z.

  PMID: 27234432 BACKGROUND

• Owatz CB, Khan AA, Schindler WG, Schwartz SA, Keiser K, Hargreaves KM. The incidence of mechanical allodynia in patients with irreversible pulpitis. J Endod. 2007 May;33(5):552-6. doi: 10.1016/j.joen.2007.01.023. Epub 2007 Mar 6.

  PMID: 17437870 BACKGROUND

• Khan AA, Owatz CB, Schindler WG, Schwartz SA, Keiser K, Hargreaves KM. Measurement of mechanical allodynia and local anesthetic efficacy in patients with irreversible pulpitis and acute periradicular periodontitis. J Endod. 2007 Jul;33(7):796-9. doi: 10.1016/j.joen.2007.01.021. Epub 2007 Mar 26.

  PMID: 17804314 BACKGROUND

• Menhinick KA, Gutmann JL, Regan JD, Taylor SE, Buschang PH. The efficacy of pain control following nonsurgical root canal treatment using ibuprofen or a combination of ibuprofen and acetaminophen in a randomized, double-blind, placebo-controlled study. Int Endod J. 2004 Aug;37(8):531-41. doi: 10.1111/j.1365-2591.2004.00836.x.

  PMID: 15230906 BACKGROUND

• Joseph P. Crowley CoADA. ADA wants Federal agencies to address Best Practices for managing acute pain. In: Vanilla M. Singh PMBPI-ATF, editor.: American Dental; Association; 2018.

  BACKGROUND

• Shamszadeh S, Shirvani A, Eghbal MJ, Asgary S. Efficacy of Corticosteroids on Postoperative Endodontic Pain: A Systematic Review and Meta-analysis. J Endod. 2018 Jul;44(7):1057-1065. doi: 10.1016/j.joen.2018.03.010. Epub 2018 Apr 30.

  PMID: 29709296 BACKGROUND

• Su N, Wang H, Zhang S, Liao S, Yang S, Huang Y. Efficacy and safety of bupivacaine versus lidocaine in dental treatments: a meta-analysis of randomised controlled trials. Int Dent J. 2014 Feb;64(1):34-45. doi: 10.1111/idj.12060. Epub 2013 Oct 11.

  PMID: 24117122 BACKGROUND

• Parirokh M, Yosefi MH, Nakhaee N, Manochehrifar H, Abbott PV, Reza Forghani F. Effect of bupivacaine on postoperative pain for inferior alveolar nerve block anesthesia after single-visit root canal treatment in teeth with irreversible pulpitis. J Endod. 2012 Aug;38(8):1035-9. doi: 10.1016/j.joen.2012.04.012. Epub 2012 May 30.

  PMID: 22794202 BACKGROUND

• Moradi S, Naghavi N. Comparison of bupivacaine and lidocaine use for postoperative pain control in endodontics. Iran Endod J. 2010 Winter;5(1):31-5. Epub 2010 Feb 20.

  PMID: 24778680 BACKGROUND

• Gordon SM, Mischenko AV, Dionne RA. Long-acting local anesthetics and perioperative pain management. Dent Clin North Am. 2010 Oct;54(4):611-20. doi: 10.1016/j.cden.2010.06.002.

  PMID: 20831925 BACKGROUND

• Balocco AL, Van Zundert PGE, Gan SS, Gan TJ, Hadzic A. Extended release bupivacaine formulations for postoperative analgesia: an update. Curr Opin Anaesthesiol. 2018 Oct;31(5):636-642. doi: 10.1097/ACO.0000000000000648.

  PMID: 30074492 BACKGROUND

• Sampaio RM, Carnaval TG, Lanfredi CB, Horliana AC, Rocha RG, Tortamano IP. Comparison of the anesthetic efficacy between bupivacaine and lidocaine in patients with irreversible pulpitis of mandibular molar. J Endod. 2012 May;38(5):594-7. doi: 10.1016/j.joen.2012.01.008. Epub 2012 Feb 4.

  PMID: 22515885 BACKGROUND

• Fernandez C, Reader A, Beck M, Nusstein J. A prospective, randomized, double-blind comparison of bupivacaine and lidocaine for inferior alveolar nerve blocks. J Endod. 2005 Jul;31(7):499-503. doi: 10.1097/01.don.0000167395.61075.38.

  PMID: 15980707 BACKGROUND

• Aggarwal V, Singla M, Miglani S. Comparative Evaluation of Anesthetic Efficacy of 2% Lidocaine, 4% Articaine, and 0.5% Bupivacaine on Inferior Alveolar Nerve Block in Patients with Symptomatic Irreversible Pulpitis: A Prospective, Randomized, Double-blind Clinical Trial. J Oral Facial Pain Headache. 2017 Spring;31(2):124-128. doi: 10.11607/ofph.1642.

  PMID: 28437508 BACKGROUND

• Parirokh M, Yosefi MH, Nakhaee N, Abbott PV, Manochehrifar H. The success rate of bupivacaine and lidocaine as anesthetic agents in inferior alveolar nerve block in teeth with irreversible pulpitis without spontaneous pain. Restor Dent Endod. 2015 May;40(2):155-60. doi: 10.5395/rde.2015.40.2.155. Epub 2015 Mar 16.

  PMID: 25984478 BACKGROUND

• St George G, Morgan A, Meechan J, Moles DR, Needleman I, Ng YL, Petrie A. Injectable local anaesthetic agents for dental anaesthesia. Cochrane Database Syst Rev. 2018 Jul 10;7(7):CD006487. doi: 10.1002/14651858.CD006487.pub2.

  PMID: 29990391 BACKGROUND

• Montero J, Lorenzo B, Barrios R, Albaladejo A, Miron Canelo JA, Lopez-Valverde A. Patient-centered Outcomes of Root Canal Treatment: A Cohort Follow-up Study. J Endod. 2015 Sep;41(9):1456-61. doi: 10.1016/j.joen.2015.06.003. Epub 2015 Jul 26.

  PMID: 26211565 BACKGROUND

• Hamasha AA, Hatiwsh A. Quality of life and satisfaction of patients after nonsurgical primary root canal treatment provided by undergraduate students, graduate students and endodontic specialists. Int Endod J. 2013 Dec;46(12):1131-9. doi: 10.1111/iej.12106. Epub 2013 Apr 6.

  PMID: 23560436 BACKGROUND

• Slade GD. Derivation and validation of a short-form oral health impact profile. Community Dent Oral Epidemiol. 1997 Aug;25(4):284-90. doi: 10.1111/j.1600-0528.1997.tb00941.x.

  PMID: 9332805 BACKGROUND

• Chou R, Gordon DB, de Leon-Casasola OA, Rosenberg JM, Bickler S, Brennan T, Carter T, Cassidy CL, Chittenden EH, Degenhardt E, Griffith S, Manworren R, McCarberg B, Montgomery R, Murphy J, Perkal MF, Suresh S, Sluka K, Strassels S, Thirlby R, Viscusi E, Walco GA, Warner L, Weisman SJ, Wu CL. Management of Postoperative Pain: A Clinical Practice Guideline From the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016 Feb;17(2):131-57. doi: 10.1016/j.jpain.2015.12.008.

  PMID: 26827847 BACKGROUND

• Shahi S, Rahimi S, Yavari HR, Ghasemi N, Ahmadi F. Success Rate of 3 Injection Methods with Articaine for Mandibular First Molars with Symptomatic Irreversible Pulpitis: A CONSORT Randomized Double-blind Clinical Trial. J Endod. 2018 Oct;44(10):1462-1466. doi: 10.1016/j.joen.2018.07.010. Epub 2018 Aug 31.

  PMID: 30174101 BACKGROUND

• Shapiro MR, McDonald NJ, Gardner RJ, Peters MC, Botero TM. Efficacy of Articaine versus Lidocaine in Supplemental Infiltration for Mandibular First versus Second Molars with Irreversible Pulpitis: A Prospective, Randomized, Double-blind Clinical Trial. J Endod. 2018 Apr;44(4):523-528. doi: 10.1016/j.joen.2017.10.003. Epub 2018 Feb 1.

  PMID: 29397214 BACKGROUND

• Hargreaves KM, Berman L. H. Cohen's Pathways of the Pulp. Missouri:Elsevier;2016

  BACKGROUND

• Olmedo-Gaya MV, Manzano-Moreno FJ, Munoz-Lopez JL, Vallecillo-Capilla MF, Reyes-Botella C. Double-blind, randomized controlled clinical trial on analgesic efficacy of local anesthetics articaine and bupivacaine after impacted third molar extraction. Clin Oral Investig. 2018 Dec;22(9):2981-2988. doi: 10.1007/s00784-018-2386-1. Epub 2018 Feb 15.

  PMID: 29450738 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Asgeir Sigurdsson

  NYU Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair Department of Endodontics

Model Details: Double blind randomized clinical trial

Study Record Dates

• First Submitted: March 4, 2021
• First Posted: March 9, 2021
• Study Start: July 29, 2019
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: November 8, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)