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Sensory Examination and Pharmacological Modulation of Oral Hyperexcitability in Patients With Atypical Odontalgia and Matched Healthy Controls

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ClinicalTrials.gov Identifier: NCT00115102
Recruitment Status : Completed
First Posted : June 21, 2005
Last Update Posted : June 20, 2006
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
This project examines experimental pain and chronic pain in the mouth, specifically the condition called atypical odontalgia (AO:atypical toothpain). In 16 patients with AO and 16 healthy persons, capsaicin (chili-pepper) is applied to the gingiva to cause pain. This pain is evaluated by the participants. In three sessions, 3 different medications are tested for effect on the pain. The medications are fentanyl, S-ketamine and placebo-treatment (saline). The aim is to know more about pain mechanisms in AO in order to develop an effective treatment.

Condition or disease Intervention/treatment Phase
Odontalgia Drug: fentanyl Drug: S-ketamine Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Diagnostic
Study Start Date : March 2004
Estimated Study Completion Date : October 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Fentanyl
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Pain
  2. Sensitivity to heat and cold
  3. Sensitivity to mechanical stimuli

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Atypical odontalgia

Exclusion Criteria:

  • BMI > 30
  • Heart conditions
  • Lung disease
  • Diseases of the liver or kidneys
  • Hypertension, untreated
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00115102


Locations
Denmark
Danish Pain Research Center
Aarhus, Denmark, DK-8000
Sponsors and Collaborators
University of Aarhus
Danish Pain Research Center
Investigators
Study Chair: Troels Staehelin Jensen, MD, PhD, Dr.Sci Aarhus University Hospital
More Information

ClinicalTrials.gov Identifier: NCT00115102     History of Changes
Other Study ID Numbers: AO1
First Posted: June 21, 2005    Key Record Dates
Last Update Posted: June 20, 2006
Last Verified: June 2006

Keywords provided by University of Aarhus:
Atypical odontalgia
capsaicin
pain
neuropathic pain

Additional relevant MeSH terms:
Toothache
Tooth Diseases
Stomatognathic Diseases
Facial Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Ketamine
Fentanyl
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Adjuvants, Anesthesia