Dental Anxiety
Conditions
Keywords
Dental Anxiety, Physical Activity, Dental Phobia, Cortisol, Amylase
Brief summary
A single bout of physical activity (treadmill)immediately prior to the dental examination reduces anxiety in patients with dental phobia.
Detailed description
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
Interventions
BEHAVIORALAerobic treadmill exercise
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).
BEHAVIORALplacebo exercise
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).
Sponsors
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in VAS - visual analog scale | Baseline and one hour after dental intervention | Change in the visual analogue scale (VAS) for anxiety |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in cortisol level | Baseline and one hour | Cortisol is one of the main hormones released by the body as a reaction to stress. |
| Change from Baseline in alpha-Amylase | Baseline and one hour after dental intervention | Salivary alpha-Amylase |
Countries
Germany
Outcome results
None listed