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Effect of Root Canal Treatment (Versus no Treatment) for Patients With Tooth Infections and Toothaches

Information source: Ohio State University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Postoperative Pain

Intervention: root canal treatment, anesthesia, pain medications, and antibiotic (Procedure); no root canal treatment, anesthesia, pain medications, and antibiotic (Procedure)

Phase: N/A

Status: Completed

Sponsored by: Ohio State University

Summary

The purpose of this study is to evaluate patients with emergency pain and a sore (infected) tooth to determine if immediate root canal therapy is better at reducing pain, when compared to initial treatment with antibiotic and pain medication followed by root canal therapy. Each participant will be randomly assigned a number, which will determine if they will receive initial endodontic treatment that day or at a later date. Each participant will receive an anesthetic injection, pain medication and a prescription for an antibiotic. They will be asked to keep a diary to record their pain level after the injection and their pain levels and the amount and type of pain medication taken each day for the next 5 days. Participants who did not receive root canal therapy at the initial appointment will receive it after the 5 day postoperative period. The pain levels and medication use will be compared between the treatment and nontreatment groups.

Clinical Details

Official title: Effect on Initial Endodontic Treatment on Postoperative Pain in Symptomatic Teeth With Pulpal Necrosis

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Percent of Patients With Success as Defined by no or Mild Pain as Analyzed on a VAS Scale and no Narcotic Use

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 18 years or older

- in good health (ASA classification I or II)

- able to give informed consent

- infected tooth with toothache (symptomatic tooth with pulpal necrosis)

Exclusion Criteria:

- allergy to ibuprofen, acetaminophen or codeine

- history of significant medical problems (ASA classification III or greater)

- angioedema or bronchospastic reactivity to aspirin or other NSAIDs

- pregnant or lactating

- inability to give informed consent

Locations and Contacts

The Ohio State University College of Dentistry, Postle Hall, Columbus, Ohio 43210, United States
Additional Information

Related publications:

Houck V, Reader A, Beck M, Nist R, Weaver J. Effect of trephination on postoperative pain and swelling in symptomatic necrotic teeth. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2000 Oct;90(4):507-13.

Nist E, Reader A, Beck M. Effect of apical trephination on postoperative pain and swelling in symptomatic necrotic teeth. J Endod. 2001 Jun;27(6):415-20.

Henry M, Reader A, Beck M. Effect of penicillin on postoperative endodontic pain and swelling in symptomatic necrotic teeth. J Endod. 2001 Feb;27(2):117-23.

Nusstein JM, Reader A, Beck M. Effect of drainage upon access on postoperative endodontic pain and swelling in symptomatic necrotic teeth. J Endod. 2002 Aug;28(8):584-8.

Mickel AK, Wright AP, Chogle S, Jones JJ, Kantorovich I, Curd F. An analysis of current analgesic preferences for endodontic pain management. J Endod. 2006 Dec;32(12):1146-54. Epub 2006 Oct 19.

Wells LK, Drum M, Nusstein J, Reader A, Beck M. Efficacy of Ibuprofen and ibuprofen/acetaminophen on postoperative pain in symptomatic patients with a pulpal diagnosis of necrosis. J Endod. 2011 Dec;37(12):1608-12. doi: 10.1016/j.joen.2011.08.026. Epub 2011 Oct 1.

Starting date: March 2013
Last updated: June 1, 2015

Page last updated: August 23, 2015

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