Clinical investigation of an aluminumtriformate mouthrinse; a double blind trial
Organizational Data
- DRKS-ID:
- DRKS00007672
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2015-01-21
- Last update in DRKS:
- 2015-01-21
- Registration type:
- Retrospective
Acronym/abbreviation of the study
No Entry
URL of the study
No Entry
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
Brief summary in scientific language
Evaluation of aluminum triformate on reduction of gum bleeding
Health condition or problem studied
- ICD10:
- K05.1 - Chronic gingivitis
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- Aluminumtriformate mouthrinse (Cional ®, 3x daily, 30 seconds each over a seven days period.
- Arm 2:
- Placebo mouthrinse, 3x daily 30 seconds each over a seven days period
Endpoints
- Primary outcome:
- The reduction of gingival bleeding is determined at baseline and after seven days using MSBI score.
- Secondary outcome:
- Theinfluence on plaque formation is determined at baseline and after seven days using API score.
Study Design
- Purpose:
- Prevention
- Allocation:
- Randomized controlled study
- Control:
-
- Placebo
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- Yes
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
-
- Investigator/therapist
- Patient/subject
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center Poliklinik für Zahnerhaltungskunde Mainz
Recruitment period and number of participants
- Planned study start date:
- No Entry
- Actual study start date:
- 2013-08-13
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2013-09-25
- Target Sample Size:
- 40
- Final Sample Size:
- 40
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- 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
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.
Addresses
Primary Sponsor
- Address:
- Universitätsmedizin MainzPoliklinik für ZahnerhaltungskundeAugustusplatz 255131 MainzGermany
- Telephone:
- 06131/177247
- Fax:
- 06131/173406
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.unimedizin-mainz.de/zahnerhaltungskunde/uebersicht.html
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Universitätsmedizin MainzPoliklinik für ZahnerhaltungskundeDr. Adriano AzaripourAugustusplatz 255131 MainzGermany
- Telephone:
- 06131/177247
- Fax:
- 06131/173406
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.unimedizin-mainz.de/zahnerhaltungskunde/uebersicht.html
Principal Investigator
- Address:
- Universitätsmedizin MainzPoliklinik für ZahnerhaltungskundeDr. Adriano AzaripourAugustusplatz 255131 MainzGermany
- Telephone:
- 06131/177247
- Fax:
- 06131/173406
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.unimedizin-mainz.de/zahnerhaltungskunde/uebersicht.html
Sources of Monetary or Material Support
Commercial (pharmaceutical industry, medical engineering industry, etc.)
- Address:
- Chemische Fabrik Kreussler & Co. GmbHRheingaustraße 87-9365203 WiesbadenGermany
- Telephone:
- 0611/9271184
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.kreussler-pharma.de/
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission bei der Landesärztekammer Rheinland-PfalzDeutschhausplatz 355116 MainzGermany
- Telephone:
- +49-6131-288220
- Fax:
- +49-6131-2882266
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2012-11-21
- Ethics committee number:
- 837.538.12(8639F)
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2012-12-14
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No Entry
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry