Exercise Treatment of Dental Anxiety

This study is currently recruiting participants.
Verified August 2013 by Charite University, Berlin, Germany
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Andreas Ströhle, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01933191
First received: July 26, 2013
Last updated: August 30, 2013
Last verified: August 2013
  Purpose

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


Condition Intervention
Dental Anxiety
Behavioral: Aerobic treadmill exercise
Behavioral: placebo exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised Placebo Controlled Cross-over Trial on Exercise Treatment of Dental Anxiety

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Change from Baseline in VAS - visual analog scale [ Time Frame: Baseline and one hour after dental intervention ] [ Designated as safety issue: No ]
    Change in the visual analogue scale (VAS) for anxiety


Secondary Outcome Measures:
  • Change from Baseline in cortisol level [ Time Frame: Baseline and one hour ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Salivary alpha-Amylase


Estimated Enrollment: 30
Study Start Date: August 2011
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: physical acticity
Experimental: Aerobic treadmill exercise (30 minutes, 70% VO2max)
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).
Other Name: physical activity VO2-70%
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).
Other Name: physical activity VO2-20%
Placebo Comparator: placebo exercise
Aerobic treadmill exercise (30 minutes, 20% VO2max)
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).
Other Name: physical activity VO2-70%
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).
Other Name: physical activity VO2-20%

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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01933191

Locations
Germany
Department of Psychiatry and Psychotherapy Campus Charité Mitte Recruiting
Berlin, Germany, 10117
Contact: Andreas Ströhle, Prof. Dr.    +4930 450517034    andreas.stroehle@charite.de   
Contact: Brigitt-Leila v. Lindenberger, M.Sc    +4930450517 273    brigitt-leila.lindenberger@charite.de   
Principal Investigator: Andreas Ströhle, Prof. Dr.         
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Principal Investigator: Andreas Ströhle, Prof. Dr. Department of Psychiatry and Psychotherapie, CCM, Charité-Universitätsmedizin Berlin
  More Information

No publications provided

Responsible Party: Prof. Dr. Andreas Ströhle, Prof. Dr., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01933191     History of Changes
Other Study ID Numbers: 221014
Study First Received: July 26, 2013
Last Updated: August 30, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by Charite University, Berlin, Germany:
Dental Anxiety, Physical Activity, Dental Phobia
Cortisol, Amylase

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014