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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: Ohio State University

Current Primary Outcome: 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.



Original Primary Outcome: pain measurement as assessed on a visual analog scale and pain medication usage [ Time Frame: for five days after initial appointment ]

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Ohio State University

Dates:
Date Received: June 4, 2013
Date Started: March 2013
Date Completion:
Last Updated: June 1, 2015
Last Verified: June 2015