Skip to main content
OpenTrials
Completed

NCT Number: NCT00631111

Study Evaluating the Efficacy of an Ibuprofen Effervescent Tablet in the Treatment of Post-Surgical Dental Pain

Evaluation of the efficacy and safety of a single dose of an ibuprofen effervescent tablet in the treatment of pain following third molar extraction in comparison to single doses of placebo, standard ibuprofen tablets, and effervescent aspirin plus vitamin C tablets.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pain Facial Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomatognathic Diseases Tooth Diseases Toothache

Age range

16 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Austin, Texas, 78705, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion:

  • Moderate or severe post-operative pain following surgical extraction of two or more third molars, at least one of which must be a partial or complete bony mandibular impaction
  • In general good health with no contraindications to the study medication or rescue medication (tramadol or acetaminophen + hydrocodone)
  • Use of only short-acting local anesthetics with or without vasocontrictor and/or nitrous oxide

Exclusion:

  • Presence of a serious medical condition (e.g., poorly controlled hypertension, diabetes, or hyper-/hypo-thyroidism; significantly impaired renal, cardiac, or hepatic function)
  • Acute localized dental alveolar infection at the time of surgery that could confound the post-surgical evaluation
  • Females who are pregnant, lactating, of child-bearing potential, or post-menopausal for less than 2 years and not using a medically-approved method of contraception

Treatment and study plan

effervescent ibuprofen tablets

Drug

effervescent Aspirin plus Vitamin C tablets

Drug

ibuprofen tablets

Drug

Placebo

Drug

Primary outcomes

  1. Sum of pain relief and pain intensity difference scores

    Time frame: 8 hours

Secondary outcomes

  1. Time to meaningful pain relief

    Time frame: 8 hours

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

Ibuprofen 400 mg Effervescent Tablet Dental Pain Study II

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Mar 7, 2008
Registry last updated
Aug 10, 2009

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.