Trial document




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  DRKS00007821

Trial Description

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Title

Treatment of periimplant mucositis with PerioChip®.
A randomized controlled clinical trial.

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Trial Acronym

[---]*

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URL of the Trial

http://-

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Brief Summary in Lay Language


Aim of the study is to investigate a simple practicable concept for the treatment of mucositis (inflammation of the mucosal around a dental implant), which simply can be performed by the dental hygienist (DH) in the recall. Thus 1-4 Periochips, when a mucositis is observed in the recall, applied to the imlantat. Periochips are gelatine chips which dissolve over a period of 10 days and proposed the disinfecting with agent chlorhexidine.
In this clinical trial are forty patients in whom mucositis was observed in regular recall, divided into two groups by drawing lots. Both groups are elucidated obtained from the DH on the findings and the relationship of mucostitis with the long-term success of the implants. They will receive an oral hygiene instruction. The implant is cleaned and disinfected by the DH.
In one group (Periochipgroup) additionally a Periochips be applied by dentist to obtain the disinfection over a longer period of time.
After three months, the general and group-specific procedure is repeated.
After 6 months, the finally check in the two groups will be held.
For participating in the trials, nothing will change compared to the procedure in a non-participating patient in our practice, except that is applied in a group a Periochip.
The products used, are all authorized products.

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Brief Summary in Scientific Language

Chronic inflammation around implants without progressive loss of the supporting bone is called periimplant mucositis. In half of patients with dental implants after 8-14 years of implant loading, mucositis is a common finding. Mucositis is the precursor of periimplantitis, which may lead to the loss of the implant, especially if left untreated. Thus, it is crucial to treat mucositis in an early stage.
Up to today, there have been attempts to reverse mucositis with disinfection and by instruction of the oral hygiene during the maintenance sessions.
With an intensified antiseptic protocol using chlorhexidine (CHX) as solution and slow-release chips, it has been shown that the treatment of periodontitis may be positively affected {Machtei et al., 2012, J Clin Periodontol, 39, 1198-205}. In addition, this intensified antiseptic protocol has also been successfully used in the treatment of periimplantitis and mucositis in patients at the Center of Dental Medicine of the University of Zurich. It is the aim of this controlled clinical study to scientifically validate our traditionally performed treatment protocol with chlorhexidine and Periochips.

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Organizational Data

  •   DRKS00007821
  •   2015/07/23
  •   [---]*
  •   yes
  •   Approved
  •   EKNZ 2015-175, EK Nordwest- und Zentralschweiz
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Secondary IDs

  •   U1111-1172-3840 
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Health Condition or Problem studied

  •   mucositis
  •   K05.5 -  Other periodontal diseases
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Interventions/Observational Groups

  •   PerioChip®-group (PerioChip® = gelatine chip with chlorhexidine). The PerioChip® applicated arround the implant after 0 and 3 months
  •   Chlorhexidine-group (Curasept ADS 1% Parodontal Gel). The gel applicated arround the Implant after 0 and 3 months
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject
  •   Active control
  •   Treatment
  •   Parallel
  •   IV
  •   No
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Primary Outcome

Primary outcome variable is bleeding-on-probing after 3 and 6 months after Baseline.

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Secondary Outcome

Secondary outcomes: Changes in the bacterial colonization (bacterial tests), a-MMP8 tests indicating the grade of collagen destruction and plaqueindex

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Countries of Recruitment

  •   Switzerland
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2015/07/17
  •   40
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

• Informed Consent as documented by signature
• Systemically healthy subjects
• At least one dental implant with mucositis in terms of a probing pocket depth less than 5 and bleeding on probing and no obvious bone loss (< 2mm).
• Ability to read and understand the patient inform

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Exclusion Criteria

• Patients with untreated periodontitis
• Pregnant or nursing women
• Patients with antibiotic therapy within the last 6 months
• Patients with periimplantitis therapy within the last 3 months
• Subjects with an allergy to or chlorhexidine
• Anti-coagulated patients
• Periimplantitis: probing pocket depth more than 5 mm and obvious bone loss (> 2mm)
• Intake of medical products containing Nystatin

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Zentrum für ZahnmedizinKlinik für Präventivzahnmedizin, Parodontologie und Kariologie
    • Mr.  Prof  Patrick  Schmidlin 
    • Plattenstr. 11
    • 8032  Zürich
    • Switzerland
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    •   0041 44 634 32 71
    •   [---]*
    •   [---]*
    •   [---]*
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    • Dr. Mattiola und Partner AG
    • Mr.  Dr.  cyrill  Bettschart 
    • Bahnhofstrasse 6
    • 5610  Wohlen
    • Switzerland
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    end of 1:1-Block address contact scientific-contact
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    • Dr. Mattiola und Partner AG
    • Mr.  Dr.  cyrill  Bettschart 
    • Bahnhofstrasse 6
    • 5610  Wohlen
    • Switzerland
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Sources of Monetary or Material Support

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    • Zentrum für ZahnmedizinKlinik für Präventivzahnmedizin, Parodontologie und Kariologie
    • Mr.  Prof  Patrick  Schmidlin 
    • Plattenstr. 11
    • 8032  Zürich
    • Switzerland
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    •   0041 44 634 32 71
    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting ongoing
  •   [---]*
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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.