Trial document





This trial has been registered retrospectively.
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  DRKS00011318

Trial Description

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Title

Randomized, controlled study comparing two mouthwashes with regard to taste assessment and reduction of oral mucosa in oncological patients "
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Octenidol® vs. Glandomed®

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Trial Acronym

mucoglan

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URL of the Trial

[---]*

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Brief Summary in Lay Language

In a comparative clinical study, the efficacy of two different oral antiseptics (octenidol versus glandomed) should be compared. The target group is especially sensitive to the inflammation of the oral mucosa: oncological patients. The objective is to evaluate the oral mucosa with regard to the occurrence of signs of mucositis on the basis of standardized scores at defined time intervals after the beginning of the treatment with the antiseptic associated with randomization (mouth mucus). Secondary target criterion is the number of germs that can be represented in defined samples and the taste assessment of the mouthwash solution.

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Brief Summary in Scientific Language

A randomized, double-blind, controlled clinical study was conducted to investigate the hypothesis: The regular use of Octenidol® for oral care has significantly reduced the degree of mucositis on day 14 after transplantation compared to chlorhexidine-containing Glandomed®
The central study hypothesis is:
The regular use of octenidine-containing Octinidol® for oral care in oncologic patients has shown a significant reduction in the degree of mucositis as compared to the chlorhexidine-containing Glandomed®, on day 14 after transplantation. It is also expected that the acceptance of oral care in oncological patients can be increased.

Patients with oncological primary disease and stem cell transplantation

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Organizational Data

  •   DRKS00011318
  •   2016/11/17
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  •   no
  •   Approved
  •   18/08, Ethik-Kommission des Fachbereichs Medizin der Philipps-Universität Marburg
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Secondary IDs

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Health Condition or Problem studied

  •   mucositis
  •   K12.3 -  Oral mucositis (ulcerative)
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Interventions/Observational Groups

  •   Patients with oncological primary disease and stem cell transplantation
    Mouthwash solution with Glandomed(Chlorhexidine digluconate) according to individual maintenance plan (5 x mouthwash) for 14 days
  •   Patients with oncological primary disease and stem cell transplantation
    Mouthwash with octenidol(Octenidi) according to individual maintenance plan (5 x mouthwash) for 14 days
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist, caregiver, assessor
  •   Active control (effective treament of control group)
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

State of mucositis by standardc scores.OMAS-Skala (Oral mucositis assessment scoale) and WHO-Skala zur Mucositis)The parameters are measured at three times in day 0, day 3, day 5 and day 14 in the morning)

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Secondary Outcome

Pain (visuel analogue scale), difficulties in swallowing, temperature, microbiological tests of saliva (bacterial material)The parameters are measured at three times, in day 0, day 3 day 5 and day 14 in the morning)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2008/10/01
  •   110
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   80   Years
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Additional Inclusion Criteria

• Participants> 18 years
• Signed declaration of consent to participate or
Written declaration of consent by the supervisor
• German speaking
• oncological patients (KMT autologous or allogeneic)

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Exclusion Criteria

• Mental disorders
• Existing mucositis before radiation therapy / chemotherapy
• Current therapy with chemotherapy or irradiation
• Incompatibility with CHX or octenidine
• Temperatures> 38 degrees Celsius before irradiation / chemotherapy
• Dental defect or loose teeth
• Infection of the upper respiratory tract

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Addresses

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    • Fa. Schülke GmbH
    • Robert – Koch Str. 2
    • 22851  Norderstedt
    • Germany
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    • Institut für medizinische Mikrobiologie und Krankenhaushygiene
    • Mr.  Prof. Dr  Reinier  Mutters 
    • Hans-Meerwein-Straße 1
    • D-35043  Marburg
    • Germany
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    • Universitätsklinikum Giessen und Marburg GmbH
    • Mr.  Dr.  Thomas  Neubert 
    • Baldingerstrasse 1
    • 35033  Marburg
    • Germany
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Sources of Monetary or Material Support

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    • Fa. Schülke GmbH
    • Robert – Koch Str. 2
    • 22851  Norderstedt
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2010/11/30
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.