Clinical trial NCT01870973: Effect of Root Canal Treatment (Versus no Treatment) for Patients With Tooth Infections and Toothaches
Official title: Effect on Initial Endodontic Treatment on Postoperative Pain in Symptomatic Teeth With Pulpal Necrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Keywords: postoperative pain
root canal treatment
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2013-06-06
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percent of Patients With Success as Defined by no or Mild Pain as Analyzed on a VAS Scale and no Narcotic Use
timeFrame: each day for 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University College of Dentistry, Postle Hall
state: Ohio
Study officials:
References:
citation: 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. doi: 10.1067/moe.2000.108960.
citation: 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. doi: 10.1097/00004770-200106000-00013.
citation: 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. doi: 10.1097/00004770-200102000-00016.
citation: 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. doi: 10.1097/00004770-200208000-00005.
citation: 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. doi: 10.1016/j.joen.2006.07.015. Epub 2006 Oct 19.
citation: 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.