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

NCT ID: NCT01870973

Last Updated: 2015-06-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2014-06-30

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.

Detailed Description

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Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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root canal treatment

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)

Group Type EXPERIMENTAL

root canal treatment, anesthesia, pain medications, and antibiotic

Intervention Type PROCEDURE

Root canal treatment is the intervention (no initial treatment versus initial treatment). We are not studying a drug or device.

no root canal treatment

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)

Group Type ACTIVE_COMPARATOR

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

Intervention Type PROCEDURE

Interventions

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root canal treatment, anesthesia, pain medications, and antibiotic

Root canal treatment is the intervention (no initial treatment versus initial treatment). We are not studying a drug or device.

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ohio State University

OTHER

Sponsor Role lead

Responsible Party

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Melissa Drum

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The Ohio State University College of Dentistry, Postle Hall

Columbus, Ohio, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 11027389 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11487138 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11491635 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12184419 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17174670 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22099891 (View on PubMed)

Other Identifiers

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root canal versus no treatment

Identifier Type: -

Identifier Source: org_study_id

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