Exercise Treatment of Dental Anxiety

Dental Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01933191
• Other study ID #: 221014
• Status: Completed
• Phase: N/A
• First received: July 26, 2013
• Last updated: February 6, 2015
• Start date: August 2011
• Est. completion date: October 2013

Study information

• Verified date: February 2015
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorders
• Dental Anxiety

Intervention

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).
• 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).

Locations

Country	Name	City	State
Germany	Department of Psychiatry and Psychotherapy Campus Charité Mitte	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in VAS - visual analog scale	Change in the visual analogue scale (VAS) for anxiety	Baseline and one hour after dental intervention	No
Secondary	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	No
Secondary	Change from Baseline in alpha-Amylase	Salivary alpha-Amylase	Baseline and one hour after dental intervention	No