Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00007672

Trial Description

start of 1:1-Block title

Title

Clinical investigation of an aluminumtriformate mouthrinse; a double blind trial

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

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

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

Brief Summary in Scientific Language

Evaluation of aluminum triformate on reduction of gum bleeding

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00007672
  •   2015/01/21
  •   [---]*
  •   yes
  •   Approved
  •   837.538.12(8639F), 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

  •   K05.1 -  Chronic gingivitis
end of 1:N-Block indications
start of 1:N-Block interventions

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

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist
  •   Placebo
  •   Prevention
  •   Parallel
  •   N/A
  •   No
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

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

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

Secondary Outcome

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

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

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2013/08/13
  •   40
  •   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

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

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

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.

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

Addresses

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