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

The Ohio State University

Status: Completed

Conditions: Postoperative Pain

Treatments: Procedure: no root canal treatment, anesthesia, pain medications, and antibiotic; Procedure: root canal treatment, anesthesia, pain medications, and antibiotic

Study type: Interventional

Funder types: Other

Identifiers

NCT01870973

root canal versus no treatment

Details and patient eligibility

About

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.

Enrollment: 108 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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108 participants in 2 patient groups

root canal treatment

Experimental group

Description:

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)

Treatment:

Procedure: root canal treatment, anesthesia, pain medications, and antibiotic

no root canal treatment

Active Comparator group

Description:

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)

Treatment:

Procedure: no root canal treatment, anesthesia, pain medications, and antibiotic