Trial document

This trial has been registered retrospectively.
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Trial Description

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Clinical investigation of an aluminumtriformate mouthrinse; a double blind trial

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Trial Acronym


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URL of the Trial


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Brief Summary in Lay Language

In the present study, the effect of aluminum trifaormate mouth rinse in peridontal patients during the maintenance phase is evaluated

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Brief Summary in Scientific Language

Evaluation of aluminum triformate on reduction of gum bleeding

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Organizational Data

  •   DRKS00007672
  •   2015/01/21
  •   [---]*
  •   yes
  •   Approved
  •   837.538.12(8639F), Ethik-Kommission bei der Landesärztekammer Rheinland-Pfalz
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Secondary IDs

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

  •   K05.1 -  Chronic gingivitis
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Interventions/Observational Groups

  •   Aluminumtriformate mouthrinse (Cional ®, 3x daily, 30 seconds each over a seven days period.
  •   Placebo mouthrinse, 3x daily 30 seconds each over a seven days period
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  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist
  •   Placebo
  •   Prevention
  •   Parallel
  •   N/A
  •   No
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Primary Outcome

The reduction of gingival bleeding is determined at baseline and after seven days using MSBI score.

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Secondary Outcome

Theinfluence on plaque formation is determined at baseline and after seven days using API score.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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  •   Actual
  •   2013/08/13
  •   40
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

History of chronic periodontitis, having had active periodontal treatment including non-surgical and surgical therapies and bein in maintenance for ≥ 1 year; ≥ 18 years old; willing to participate and willing to sign the informed consent; Having a modified sulcus bleeding index (MSBI) of ≥ 40 %; No pocket depths ≥ 6 mm; at least 20 teeth (at least 5 teeth in each quadrant); systemically healthy

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Exclusion Criteria

Known hypersensitivity to ATF; known hypersensitivity to other ingredients of Cional® (Cremophor RH40, peppermint oil, mint oil, propylene glycol, glycerol); any antibiotic therapy < 3 months before treatment; smoker; pregnancy or wish for pregnancy; participation in another clinical study; lack of ability to participate in the screening appointments.

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Sources of Monetary or Material Support

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    • Chemische Fabrik Kreussler & Co. GmbH
    • Rheingaustraße 87-93
    • 65203  Wiesbaden
    • Germany
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  •   Recruiting complete, follow-up complete
  •   2013/09/25
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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.