Effect of Root Canal Treatment (Versus no Treatment) for Patients With Tooth Infections and Toothaches
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
root canal treatment, anesthesia, pain medications, and antibiotic
no root canal treatment, anesthesia, pain medications, and antibiotic
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain focused on measuring postoperative pain, root canal treatment
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
Sites / Locations
- The Ohio State University College of Dentistry, Postle Hall
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
root canal treatment
no root canal treatment
Arm 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)
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)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01870973
Brief Title
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
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
postoperative pain, root canal treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
108 (Actual)
8. Arms, Groups, and Interventions
Arm Title
root canal treatment
Arm Type
Experimental
Arm 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)
Arm Title
no root canal treatment
Arm Type
Active Comparator
Arm 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)
Intervention Type
Procedure
Intervention Name(s)
root canal treatment, anesthesia, pain medications, and antibiotic
Intervention Description
Root canal treatment is the intervention (no initial treatment versus initial treatment). We are not studying a drug or device.
Intervention Type
Procedure
Intervention Name(s)
no root canal treatment, anesthesia, pain medications, and antibiotic
Primary Outcome Measure Information:
Title
Percent of Patients With Success as Defined by no or Mild Pain as Analyzed on a VAS Scale and no Narcotic Use
Description
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.
Time Frame
each day for 5 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
The Ohio State University College of Dentistry, Postle Hall
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
11027389
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.
Results Reference
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PubMed Identifier
11487138
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.
Results Reference
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PubMed Identifier
11491635
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.
Results Reference
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PubMed Identifier
12184419
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.
Results Reference
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PubMed Identifier
17174670
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.
Results Reference
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PubMed Identifier
22099891
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.
Results Reference
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Effect of Root Canal Treatment (Versus no Treatment) for Patients With Tooth Infections and Toothaches
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