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

Study Overview
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Brief Summary
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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.

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

Conditions
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Postoperative Pain

Intervention / Treatment
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* Procedure: root canal treatment, anesthesia, pain medications, and antibiotic
* Procedure: no root canal treatment, anesthesia, pain medications, and antibiotic


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: root canal treatment<br>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<br>* Root canal treatment is the intervention (no initial treatment versus initial treatment). We are not studying a drug or device.<br>|
| Active Comparator: no root canal treatment<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postoperative pain, root canal treatment