Back to resultsSensory Examination and Pharmacological Modulation of Oral Hyperexcitability in Patients With Atypical Odontalgia and Matched Healthy Controls
Primary Purpose
Odontalgia
Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
fentanyl
S-ketamine
Sponsored by
About this trial
This is an interventional diagnostic trial for Odontalgia focused on measuring Atypical odontalgia, capsaicin, pain, neuropathic pain
Eligibility Criteria
Inclusion Criteria: Atypical odontalgia Exclusion Criteria: BMI > 30 Heart conditions Lung disease Diseases of the liver or kidneys Hypertension, untreated
Sites / Locations
- Danish Pain Research Center
Outcomes
Primary Outcome Measures
Pain
Sensitivity to heat and cold
Sensitivity to mechanical stimuli
Secondary Outcome Measures
Full Information
NCT ID
NCT00115102
First Posted
June 20, 2005
Last Updated
June 15, 2006
Sponsor
University of Aarhus
Collaborators
Danish Pain Research Center
1. Study Identification
Unique Protocol Identification Number
NCT00115102
Brief Title
Sensory Examination and Pharmacological Modulation of Oral Hyperexcitability in Patients With Atypical Odontalgia and Matched Healthy Controls
Study Type
Interventional
2. Study Status
Record Verification Date
June 2006
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Aarhus
Collaborators
Danish Pain Research Center
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Odontalgia
Keywords
Atypical odontalgia, capsaicin, pain, neuropathic pain
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
20 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
fentanyl
Intervention Type
Drug
Intervention Name(s)
S-ketamine
Primary Outcome Measure Information:
Title
Pain
Title
Sensitivity to heat and cold
Title
Sensitivity to mechanical stimuli
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Atypical odontalgia
Exclusion Criteria:
BMI > 30
Heart conditions
Lung disease
Diseases of the liver or kidneys
Hypertension, untreated
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Troels Staehelin Jensen, MD, PhD, Dr.Sci
Organizational Affiliation
Aarhus University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Danish Pain Research Center
City
Aarhus
ZIP/Postal Code
DK-8000
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Sensory Examination and Pharmacological Modulation of Oral Hyperexcitability in Patients With Atypical Odontalgia and Matched Healthy Controls
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