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OpenTrials
Completed

NCT Number: NCT01933191

Exercise Treatment of Dental Anxiety

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

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Key information

Conditions

Dental Anxiety Behavior Motor Activity

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Psychiatry and Psychotherapy Campus Charité Mitte

Berlin, 10117, Germany

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aerobic treadmill exercise

Behavioral

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).

Other names: physical activity VO2-70%

placebo exercise

Behavioral

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).

Other names: physical activity VO2-20%

Primary outcomes

  1. Change from Baseline in VAS - visual analog scale

    Time frame: Baseline and one hour after dental intervention

    Change in the visual analogue scale (VAS) for anxiety

Secondary outcomes

  1. Change from Baseline in cortisol level

    Time frame: Baseline and one hour

    Cortisol is one of the main hormones released by the body as a reaction to stress.

  2. Change from Baseline in alpha-Amylase

    Time frame: Baseline and one hour after dental intervention

    Salivary alpha-Amylase

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Sep 2, 2013
Registry last updated
Feb 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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