Trial document





This trial has been registered retrospectively.
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  DRKS00009552

Trial Description

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Title

Changes of the salivary cortisol in patients with dental phobia before and after psychotheapeutic treatment.

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

The salivary cortisol concentreation reflects the pysilological stress state. With the STAI-state inventrory the psychological stress state is determined. Using both parameters the effects of psychotherapeutic treatment on the subjective (STAI-state) and objective (salivary cortisol) stress state will be investigated.

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Organizational Data

  •   DRKS00009552
  •   2015/10/22
  •   [---]*
  •   yes
  •   Approved
  •   93/2011, Ethik-Kommission der Universität Witten/Herdecke
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   F40.9 -  Phobic anxiety disorder, unspecified
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Interventions/Observational Groups

  •   Forty patients will participate in this study and will belong to two different groups. All patients will receive written information and sign informed consent to participate in the study. Group 1 consists of 20 patients with dental phobia and group 2 consists of patients without dental phobia. Dental phobia is diagnosed using the validated standardized dental anxiety scale (DAS).
    Saliva is collected for 5 minutes at three time intervals (T0-T2). The first collection is immediately after entering the dental office (T0) which is followed by a 10 minute dental investigation. Immediately after the dental investigation the second saliva collection (T1) follows. Then, the dental phobic patients undergo a three week the psychotherapeutic treatment. Psychotherapy comprises 1 hour per week. In the first session the triggering stress factors are explored and strategies for stress coping developed. During the second session stress coping is trained and relaxation exercises are started. In the third session actively dental treatment is discussed using a video demonstrating a dental treatment. Also first signs of recidivism are explored and how the patents con overcome them. After psychotherapeutic treatment a dental treatment follows with a third saliva collection (T2) after the treatment.
  •   Group 2 consists of 20 patients with no dental phobia. This control group follows the same scheme as the dental phobic patients but without psychotherapy.
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Caomparision of the DAS score values at T0 and T2.

time points:
immediately after entering the dental office (T0),
immediately after the dental investigation (T1),
after the second dental investigation (T2)

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Secondary Outcome

Statistical comparison of the following parameters at measuring time points T0 and T2:

STAI-state scores, calivary cortisol concentration, proteinconcentration, salivary secretion rate



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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2011/12/01
  •   40
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   18   Years
  •   60   Years
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Additional Inclusion Criteria

Phobic patients mus show a minimum DAS score of 38. Saliva is collected after 2 pm.

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Exclusion Criteria

hormonal treatment; endicrinological diseases (e.g. hyperthyroidy); radiation within the head and neck area.

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Addresses

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    • Universität Witten/Herdecke
    • Alfred Herrhausenstraße 50
    • 58448  Witten
    • Germany
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    • Universität Witten/HerdeckeLehrstuhl für biologische und materialkundliche Grundlagen der Zahnmedizin
    • Mr.  Prof. Dr.  Wolfgang H.  Arnold 
    • Alfred Herrhausenstraße 44
    • 58455  Witten
    • Germany
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    • Zahnklink Bochum
    • Mr.  Prof. Dr.  Peter  Jöhren 
    • Bergstraße 26
    • 44791  Bochum
    • Germany
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Sources of Monetary or Material Support

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    • Universität Witten/HerdeckeLehrstuhl für biologische und materialkundliche Grundlagen der Zahnmedizin
    • Mr.  Prof. Dr.  Wolfgang H.  Arnold 
    • Alfred Herrhausenstraße 44
    • 58455  Witten
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2015/08/31
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Trial Publications, Results and other Documents

  •   Naumova et al. BMC Oral Health (2017) 17:32 DOI 10.1186/s12903-016-0264-2
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* This entry means the parameter is not applicable or has not been set.