Evaluation of Methylprednisolone or Ibuprofen on Efficacy of Nerve Blocks With Symptomatic Irreversible Pulpitis

NCT04157036 | Terminated Phase 3 FDA Drug

• 1 other identifier: WRNMMC-2019-0249
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective, randomized, double-blind study will compare the effect of oral premedication of ibuprofen and methylprednisolone on the anesthetic efficacy of an Inferior Alveolar Nerve Block (IANB) in adult patients with symptomatic irreversible pulpitis.

Conditions

Irreversible Pulpitis

Keywords

Inferior alveolar nerve block; Symptomatic irreversible pulpitis; Preoperative steroid; Preoperative NSAID

Outcome Measures

Primary Outcomes (1)

• Analgesic Effect on Nerve Block

  To compare the effect of two oral pre-medications, ibuprofen and methylprednisolone, on the anesthetic efficacy of the inferior alveolar nerve block (IANB) using a VAS scale in patients with symptomatic irreversible pulpitis. The scale is 100mm long. If the subject experiences pain during the procedure, he/she will mark the scale. If it is marked at 50mm or lower, the nerve block is considered a success (no or mild pain), if it is marked above 50mm, the nerve block failed and supplemental anesthetic will be administered. We will be looking at whether the preoperative medications had an effect on the nerve block success.

  48 hours

Secondary Outcomes (2)

• Analgesic Effect on Supplemental Anesthesia Techniques

  48 hours

• Analgesic Effect on Post-Operative Pain

  48 hours

Study Arms (2)

800mg Ibuprofen

EXPERIMENTAL

Subject will take 800mg of Ibuprofen 45 minutes prior to anesthetic delivery.

Drug: Ibuprofen

40mg Methylprednisolone

EXPERIMENTAL

Subject will take 40mg of Methylprednisolone 45 minutes prior to anesthetic delivery.

Drug: Methylprednisolone

Interventions

Ibuprofen DRUG

Subject will take 800mg Ibuprofen 45 minutes prior to anesthetic delivery

800mg Ibuprofen

Methylprednisolone DRUG

Subject will take 40mg Methylprednisolone 45 minutes prior to anesthetic delivery

40mg Methylprednisolone

Eligibility Criteria

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

You may qualify if:

• years or older
• Has a vital mandibular posterior tooth experiencing pain
• Has a prolonged response to thermal cold testing using Green Endo Ice (1, 1, 1, 2 tetraflouroethane
• Diagnosis of symptomatic irreversible pulpitis

You may not qualify if:

• Has taken an analgesic within the past 8 hours
• Allergies or sensitivities to Ibuprofen or Methylprednisolone
• Allergies or sensitivities to local anesthetics or sulfites
• Pregnant or nursing
• Has a history of a serious medical condition preventing routine dental treatment
• Has a medical condition requiring the use of steroid medications
• Active or latent peptic ulcers
• Crohn's Disease
• Ulcerative colitis
• Gastroesophageal reflux
• Systemic fungal infection
• Active herpetic infection
• Asthma
• Open-angle glaucoma
• Cirrhosis

Sponsors & Collaborators

• Walter Reed National Military Medical Center: lead

Study Sites (1)

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Location

Related Publications (10)

• Nagendrababu V, Pulikkotil SJ, Veettil SK, Teerawattanapong N, Setzer FC. Effect of Nonsteroidal Anti-inflammatory Drug as an Oral Premedication on the Anesthetic Success of Inferior Alveolar Nerve Block in Treatment of Irreversible Pulpitis: A Systematic Review with Meta-analysis and Trial Sequential Analysis. J Endod. 2018 Jun;44(6):914-922.e2. doi: 10.1016/j.joen.2018.02.017. Epub 2018 Apr 27.

  PMID: 29709297 RESULT

• Aggarwal V, Singla M, Kabi D. Comparative evaluation of effect of preoperative oral medication of ibuprofen and ketorolac on anesthetic efficacy of inferior alveolar nerve block with lidocaine in patients with irreversible pulpitis: a prospective, double-blind, randomized clinical trial. J Endod. 2010 Mar;36(3):375-8. doi: 10.1016/j.joen.2009.11.010.

  PMID: 20171350 RESULT

• Fowler S, Drum M, Reader A, Beck M. Anesthetic Success of an Inferior Alveolar Nerve Block and Supplemental Articaine Buccal Infiltration for Molars and Premolars in Patients with Symptomatic Irreversible Pulpitis. J Endod. 2016 Mar;42(3):390-2. doi: 10.1016/j.joen.2015.12.025. Epub 2016 Jan 28.

  PMID: 26831048 RESULT

• Fowler S, Reader A, Beck M. Incidence of missed inferior alveolar nerve blocks in vital asymptomatic subjects and in patients with symptomatic irreversible pulpitis. J Endod. 2015 May;41(5):637-9. doi: 10.1016/j.joen.2015.01.029. Epub 2015 Mar 11.

  PMID: 25770038 RESULT

• Drum M, Reader A, Nusstein J, Fowler S. Successful pulpal anesthesia for symptomatic irreversible pulpitis. J Am Dent Assoc. 2017 Apr;148(4):267-271. doi: 10.1016/j.adaj.2017.01.002. Epub 2017 Feb 9.

  PMID: 28190451 RESULT

• Henry MA, Hargreaves KM. Peripheral mechanisms of odontogenic pain. Dent Clin North Am. 2007 Jan;51(1):19-44, v. doi: 10.1016/j.cden.2006.09.007.

  PMID: 17185058 RESULT

• Nagori SA, Jose A, Roy ID, Chattopadhyay PK, Roychoudhury A. Does methylprednisolone improve postoperative outcomes after mandibular third molar surgery? A systematic review and meta-analysis. Int J Oral Maxillofac Surg. 2019 Jun;48(6):787-800. doi: 10.1016/j.ijom.2018.09.005. Epub 2018 Oct 9.

  PMID: 30314709 RESULT

• Collins SL, Moore RA, McQuay HJ. The visual analogue pain intensity scale: what is moderate pain in millimetres? Pain. 1997 Aug;72(1-2):95-7. doi: 10.1016/s0304-3959(97)00005-5.

  PMID: 9272792 RESULT

• Nusstein J, Reader A, Nist R, Beck M, Meyers WJ. Anesthetic efficacy of the supplemental intraosseous injection of 2% lidocaine with 1:100,000 epinephrine in irreversible pulpitis. J Endod. 1998 Jul;24(7):487-91. doi: 10.1016/S0099-2399(98)80053-8.

  PMID: 9693577 RESULT

• Reisman D, Reader A, Nist R, Beck M, Weaver J. Anesthetic efficacy of the supplemental intraosseous injection of 3% mepivacaine in irreversible pulpitis. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1997 Dec;84(6):676-82. doi: 10.1016/s1079-2104(97)90372-3.

  PMID: 9431539 RESULT

MeSH Terms

Interventions

Ibuprofen; Methylprednisolone

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Advanced Specialty Program in Endodontics

Study Record Dates

• First Submitted: November 6, 2019
• First Posted: November 8, 2019
• Study Start: February 1, 2020
• Primary Completion: September 1, 2021
• Study Completion: October 6, 2021
• Last Updated: August 29, 2022

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)