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OpenTrials
Completed

NCT Number: NCT01870973

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

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.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Ohio State University College of Dentistry, Postle Hall

Columbus, Ohio, 43210, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

root canal treatment, anesthesia, pain medications, and antibiotic

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, anesthesia, pain medications, and antibiotic

Procedure

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

    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.

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jun 6, 2013
Registry last updated
Jun 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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