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

Odontalgia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00115102
• Other study ID #: AO1
• Status: Completed
• Phase: Phase 4
• First received: June 20, 2005
• Last updated: June 15, 2006
• Start date: March 2004
• Est. completion date: October 2005

Study information

• Verified date: June 2006
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Atypical odontalgia

Exclusion Criteria:

• BMI > 30

• Heart conditions

• Lung disease

• Diseases of the liver or kidneys

• Hypertension, untreated

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Odontalgia
• Toothache

Intervention

Drug:
• fentanyl

• S-ketamine

Locations

Country	Name	City	State
Denmark	Danish Pain Research Center	Aarhus

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Danish Pain Research Center

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain
Primary	Sensitivity to heat and cold
Primary	Sensitivity to mechanical stimuli