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

Not Applicable

Completed

• Conditions: Postoperative Pain
• Interventions: Procedure: root canal treatment, anesthesia, pain medications, and antibiotic; Procedure: no root canal treatment, anesthesia, pain medications, and antibiotic

• Registration Number: NCT01870973
• Lead Sponsor: Ohio State University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-06-04
• Study First Submitted QC: 2013-06-04
• Study First Posted: 2013-06-06
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Results First Submitted: 2015-04-20
• Status Verified: 2015-06
• Results First Submitted QC: 2015-06-01
• Last Update Submitted: 2015-06-01
• Results First Posted: 2015-06-18
• Last Update Posted: 2015-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
root canal treatment	root canal treatment, anesthesia, pain medications, and antibiotic	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)
no root canal treatment	no root canal treatment, anesthesia, pain medications, and antibiotic	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)

Primary Outcome Measures

Name	Time	Method
Percent of Patients With Success as Defined by no or Mild Pain as Analyzed on a VAS Scale and no Narcotic Use	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.

Trial Locations

Locations (1)

The Ohio State University College of Dentistry, Postle Hall; 🇺🇸 Columbus, Ohio, United States