Exercise Treatment of Dental Anxiety

Study Overview
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Brief Summary
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A single bout of physical activity (treadmill)immediately prior to the dental examination reduces anxiety in patients with dental phobia.

Detailed Description
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The primary objective of the trial is to assess the anxiolytic efficacy of 30 minutes aerobic treadmill exercise versus placebo exercise in subjects experiencing high anxiety prior to a minor dental dental procedure. Primary efficacy endpoint: Change in the visual analogue scale (VAS) for anxiety before and after the intervention prior to the elective minor dental procedure

Official Title
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A Randomised Placebo Controlled Cross-over Trial on Exercise Treatment of Dental Anxiety

Conditions
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Dental Anxiety

Intervention / Treatment
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* Behavioral: Aerobic treadmill exercise
* Behavioral: placebo exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female outpatients 18 years of age or older A total score of 12 points or more on the Dental Anxiety Scale at screening and baseline evaluations Scheduled appointment for an elective minor dental procedure Informed consent Exclusion Criteria: Pregnant or lactating women Current diagnosis of any other DSM-IV, with the exception of other phobic disorders, social anxiety disorder or dysthymia Serious medical disorders which put subjects at risk if they have to exercise 30 minutes at 70% VO2max

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: physical acticity<br>Experimental: Aerobic treadmill exercise (30 minutes, 70% VO2max) | Behavioral: Aerobic treadmill exercise<br>* Experimental training: Aerobic treadmill exercise (30 minutes, 70% VO2max) prior to an elective minor dental procedures (e.g., extractions, endodontics, apicoectomies, dental restorations, periodontal treatment, dental implants).<br>* Other names: physical activity VO2-70%;Behavioral: placebo exercise<br>* placebo exercise: Aerobic treadmill exercise (30 minutes, 20% VO2max) prior to an elective minor dental procedures (e.g., extractions, endodontics, apicoectomies, dental restorations, periodontal treatment, dental implants).<br>* Other names: physical activity VO2-20%;|
| Placebo Comparator: placebo exercise<br>Aerobic treadmill exercise (30 minutes, 20% VO2max) | Behavioral: Aerobic treadmill exercise<br>* Experimental training: Aerobic treadmill exercise (30 minutes, 70% VO2max) prior to an elective minor dental procedures (e.g., extractions, endodontics, apicoectomies, dental restorations, periodontal treatment, dental implants).<br>* Other names: physical activity VO2-70%;Behavioral: placebo exercise<br>* placebo exercise: Aerobic treadmill exercise (30 minutes, 20% VO2max) prior to an elective minor dental procedures (e.g., extractions, endodontics, apicoectomies, dental restorations, periodontal treatment, dental implants).<br>* Other names: physical activity VO2-20%;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in VAS - visual analog scale | Change in the visual analogue scale (VAS) for anxiety | Baseline and one hour after dental intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in cortisol level | Cortisol is one of the main hormones released by the body as a reaction to stress. | Baseline and one hour | 
| Change from Baseline in alpha-Amylase | Salivary alpha-Amylase | Baseline and one hour after dental intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dental Anxiety, Physical Activity, Dental Phobia, Cortisol, Amylase