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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01870973
• Other study ID #: root canal versus no treatment
• Status: Completed
• Phase: N/A
• First received: June 4, 2013
• Last updated: June 1, 2015
• Start date: March 2013
• Est. completion date: June 2014

Study information

• Verified date: June 2015
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• root canal treatment, anesthesia, pain medications, and antibiotic
Root canal treatment is the intervention (no initial treatment versus initial treatment). We are not studying a drug or device.
• no root canal treatment, anesthesia, pain medications, and antibiotic

Locations

Country	Name	City	State
United States	The Ohio State University College of Dentistry, Postle Hall	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of Patients With Success as Defined by no or Mild Pain as Analyzed on a VAS Scale and no Narcotic Use	pain measurement as assessed on a visual analog scale and pain medication usage; definition of success = no or mild pain as analyzed on VAS scale and no narcotic use; analyzed by logistic regression; VAS scale is 0 to 170 mm with the higher numbers indicating more pain and less success.	each day for 5 days	No