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

June 1, 2015 updated by: Melissa Drum, Ohio State University

Effect on Initial Endodontic Treatment on Postoperative Pain in Symptomatic Teeth With Pulpal Necrosis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

108

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University College of Dentistry, Postle Hall

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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)
Procedure: 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.
ACTIVE_COMPARATOR: 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)
Procedure: no root canal treatment, anesthesia, pain medications, and antibiotic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent of Patients With Success as Defined by no or Mild Pain as Analyzed on a VAS Scale and no Narcotic Use
Time Frame: each day for 5 days

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ohio State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (ACTUAL)

June 1, 2014

Study Completion (ACTUAL)

June 1, 2014

Study Registration Dates

First Submitted

June 4, 2013

First Submitted That Met QC Criteria

June 4, 2013

First Posted (ESTIMATE)

June 6, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

June 18, 2015

Last Update Submitted That Met QC Criteria

June 1, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • root canal versus no treatment

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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