Exercise Treatment of Dental Anxiety

Overview

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

Full Title of Study: “A Randomised Placebo Controlled Cross-over Trial on Exercise Treatment of Dental Anxiety”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: September 2013

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

  • Behavioral: Aerobic 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).
  • Behavioral: placebo 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).

Arms, Groups and Cohorts

  • Experimental: physical acticity
    • Experimental: Aerobic treadmill exercise (30 minutes, 70% VO2max)
  • Placebo Comparator: placebo exercise
    • Aerobic treadmill exercise (30 minutes, 20% VO2max)

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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.
  • Change from Baseline in alpha-Amylase
    • Time Frame: Baseline and one hour after dental intervention
    • Salivary alpha-Amylase

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Charite University, Berlin, Germany
  • Provider of Information About this Clinical Study
    • Principal Investigator: Prof. Dr. Andreas Ströhle, Prof. Dr. – Charite University, Berlin, Germany
  • Overall Official(s)
    • Andreas Ströhle, Prof. Dr., Principal Investigator, Department of Psychiatry and Psychotherapie, CCM, Charité-Universitätsmedizin Berlin

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