NCT01870973

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P75+ for not_applicable postoperative-pain

Timeline
Completed

Started Mar 2013

Typical duration for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 4, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 6, 2013

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
1 year until next milestone

Results Posted

Study results publicly available

June 18, 2015

Completed
Last Updated

June 18, 2015

Status Verified

June 1, 2015

Enrollment Period

1.3 years

First QC Date

June 4, 2013

Results QC Date

April 20, 2015

Last Update Submit

June 1, 2015

Conditions

Postoperative Pain

Keywords

postoperative painroot canal treatment

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

root canal treatment

EXPERIMENTAL

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

no root canal treatment

ACTIVE COMPARATOR

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

Interventions

root canal treatment, anesthesia, pain medications, and antibioticPROCEDURE

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

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University College of Dentistry, Postle Hall

Columbus, Ohio, 43210, United States

Location

Related Publications (6)

  • 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.

    PMID: 11027389BACKGROUND

  • 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.

    PMID: 11487138BACKGROUND

  • 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.

    PMID: 11491635BACKGROUND

  • 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.

    PMID: 12184419BACKGROUND

  • 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.

    PMID: 17174670BACKGROUND

  • 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.

    PMID: 22099891BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

AnesthesiaAnti-Bacterial Agents

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia and AnalgesiaAnti-Infective AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Results Point of Contact

Title
Dr. Melissa Drum
Organization
The Ohio State University
drum.13@osu.edu
6142923596

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 4, 2013

First Posted

June 6, 2013

Study Start

March 1, 2013

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

June 18, 2015

Results First Posted

June 18, 2015

Record last verified: 2015-06

Locations

US(1)