Trial document



drksid header

  DRKS00003462

Trial Description

start of 1:1-Block title

Title

Interactions between chronic orofacial pain, sleep disorder and bruxism (clenching/grinding)

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Many people suffer from stress, insomnia and bruxism. In the long term chronical orofacial pain can develop. The precise relationship between insomnia, teeth grinding and facial pain has been studied very little. Sufficiently well known, however is, that an improved stress management has a positive effect on both sleep quality and pain processing. The aim of this study is to investigate the relationship between teeth grinding, chronic orofacial pain and insomnia as well as to clarify the effectiveness of a stress-reducing treatment regarding MBSR (Mindfulness Based Stress Reduction).

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

As part of an interdisciplinary prospective clinical study sleep parameters will be checked at patients with orofacial pain, bruxism and sleep disorder in order to clarify the question whether a further differentiation within this group of patients is possible. Furtheron it should be examined whether a mindfulness-based therapeutic treatment in a group leads to a change of the parameter "pain" - with the overarching aim to create a differentiated interdisciplinary concept of treatment for this patient group.

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

Do you plan to share individual participant data with other researchers?

[---]*

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

[---]*

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00003462
  •   2012/01/16
  •   [---]*
  •   yes
  •   Approved
  •   837.318.11(7860), Ethik-Kommission bei der Landesärztekammer Rheinland-Pfalz
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   chronic orofacial pain, insomnia, bruxism
  •   G47 -  Sleep disorders
  •   F45.8 -  Other somatoform disorders
  •   R51 -  Headache
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   MBSR (mindfulness-based stress reduction): The psychotherapeutic intervention takes place in the group, each with 10-15 participants. It will last over eight sessions weekly with 2.5 to 3.5 hours per meeting. Contents will be the instruction in the formal methods of mindfulness (including body scan meditation, Hatah yoga, sitting meditation, walking meditation) and in the informal practice of mindfulness (mindfulness in everyday life). In the 6th week an all-day silent retreat is planned. Participants will receive for the practice of fomal mindfulness a special CD (45 min per day). The informal mindfulness should be practiced six days per week for 5-15 min.

end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Main target is the bruxism index, that will be defined pre-and post-intervention by using the "Grindcare" and EMG derivation in the polysomnography.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Further targets are 1. sleep parameters (subjective based on questionnaires as PSQI/ Munich Parasomnia Screening/ International RLS Study group Rating Scale/Epworth Sleepiness Scale/ Jenkins)
standardized sleep protocol of the German Society for Sleep Medicine and objectively using polysomnography 2. chronic pain: by using individualized pain questionnaire, HADS 3. Salivary cortisol (determination cortisollevels before and after MBSR).

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • Doctor's Practice 
  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Planned
  •   2012/01/16
  •   50
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

minimal age of 18 years, patients with at least 3 months of chronic orofacial pain, patients with insomnia, patients with Parafnktionenbruxism, dentition with at least prosthetic rehabilitation on both sides, no presence of occlusal trigger, good compliance, sufficient knowledge of German language,
no analgetic and/or psychotropic medication (or cessation of medication at least three weeks prior study onset)

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

Age under 18 years, presence of occlusal interferences or triggers, no good compliance,
insufficient german language skills,
abusive alcohol consumption or alcohol dependence, excessive nicotine or other addictive disorders,
patients with sleep-associated breathing disorder, patients with neurological diseases,
patients with serious psychiatric disorders, patients with a complete denture care or no teeth, patients taking centrally acting drugs,co-analgetics and/ or psychotropic medication

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Poliklinik für Zahnärztliche Chirurgie
    • Ms.  Univ.-Prof. Dr. Dr.   Monika  Daubländer 
    • Augustusplatz 2
    • 55131  Mainz
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Poliklinik für Zahnärztliche Chirurgie
    • Ms.  Dr.   Anastasia  Mouratidou 
    • Augustusplatz 2
    • 55131  Mainz
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Poliklinik für Zahnärztliche Chirurgie
    • Ms.  Dr.   Anastasia  Mouratidou 
    • Augustusplatz 2
    • 55131  Mainz
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Poliklinik für Zahnärztliche Chirurgie, Minazer Forschungsförderprogramm "MAIFOR"
    • Ms.  Dr.   Anastasia  Mouratidou 
    • Augustusplatz 2
    • 55131  Mainz
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.