N/A
N=108
Effect of Root Canal Treatment (Versus no Treatment) for Patients With Tooth Infections and Toothaches
Postoperative Pain
Bottom Line
View on ClinicalTrials.gov: NCT01870973 ↗Enrolled (actual)
108
Serious AEs
0.0%
Results posted
Jun 2015
Primary outcome: Primary: Percent of Patients With Success as Defined by no or Mild Pain as Analyzed on a VAS Scale and no Narcotic Use — 52; 43 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- root canal treatment, anesthesia, pain medications, and antibiotic (Procedure); no root canal treatment, anesthesia, pain medications, and antibiotic (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ohio State University
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Patients With Success as Defined by no or Mild Pain as Analyzed on a VAS Scale and no Narcotic Use |
52; 43 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01870973). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.