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

• ClinicalTrials.gov Identifier: NCT01870973
• Recruitment Status: Completed
• First Posted: June 6, 2013
• Results First Posted: June 18, 2015
• Last Update Posted: June 18, 2015
• Sponsor: Ohio State University
• Information provided by (Responsible Party): Melissa Drum, Ohio State University

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Postoperative Pain	Procedure: root canal treatment, anesthesia, pain medications, and antibiotic; Procedure: no root canal treatment, anesthesia, pain medications, and antibiotic	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 108 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effect on Initial Endodontic Treatment on Postoperative Pain in Symptomatic Teeth With Pulpal Necrosis
• Study Start Date: March 2013
• Actual Primary Completion Date: June 2014
• Actual Study Completion Date: June 2014

Arms and Interventions

Arm	Intervention/treatment
Experimental: root canal treatment; root canal treatment, anesthesia with 2% lidocaine with 1:100,000 epinephrine, pain medication (1000 mg acetaminophen and 600 mg ibuprofen every 6 hours)five day supply, antibiotic (500 mg penicillin, if allergic 300 mg clindamycin)	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.
Active Comparator: no root canal treatment; no root canal treatment, anesthesia with 2% lidocaine with 1:100,000 epinephrine, pain medication (1000 mg acetaminophen and 600 mg ibuprofen every 6 hours)five day supply, antibiotic (500 mg penicillin if allergic 300 mg clindamycin)	Procedure: no root canal treatment, anesthesia, pain medications, and antibiotic

Outcome Measures

Primary Outcome Measures :

1. Percent of Patients With Success as Defined by no or Mild Pain as Analyzed on a VAS Scale and no Narcotic Use [ Time Frame: each day for 5 days ]

   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Ohio

The Ohio State University College of Dentistry, Postle Hall

Columbus, Ohio, United States, 43210

Sponsors and Collaborators

Ohio State University

More Information

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.

• Responsible Party: Melissa Drum, Associate Professor, Ohio State University
• ClinicalTrials.gov Identifier: NCT01870973
• Other Study ID Numbers: root canal versus no treatment
• First Posted: June 6, 2013
• Results First Posted: June 18, 2015
• Last Update Posted: June 18, 2015
• Last Verified: June 2015

Keywords provided by Melissa Drum, Ohio State University:

postoperative pain; root canal treatment

Additional relevant MeSH terms:

Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Anti-Bacterial Agents; Antibiotics, Antitubercular; Analgesics; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Anti-Infective Agents; Antitubercular Agents; Sensory System Agents; Peripheral Nervous System Agents