Trial document




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  DRKS00006296

Trial Description

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Title

Controlled, randomized trial of trehalose powder in air-polishing for subgingival debridement during supportive periodontal treatment.

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Trial Acronym

Crtotpiafsddspt

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Regular cleaning of the root surface of tooth with periodontal pockets during maintenance plays an outstanding role for periodontitis patients in order to achieve succeess in therapy. The Participants of the study are patients in periodontal maintenance whose last systematic periodontitis therapy hasn’t dated back longer than 2 years. The study compares the effectiveness of root cleaning via ultrasonic device to cleaning via air-polishing. The powder being used is trehalose. The main criteria of the comparison is the level of attachment after 3 and after 6 months.

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Brief Summary in Scientific Language

Randomized blinded split-mouth studyfor comparison of ultrasonic cleaning to cleaning via air-polishing of subgingival tooth surfaces with patients in PMT. The powder being used for air-polishing is trehalose. Crieria for comparison is the level of attachment after 3 and after 6 months as well as changes of the microbiological findings in the pocket during the study.

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Organizational Data

  •   DRKS00006296
  •   2015/06/10
  •   [---]*
  •   no
  •   Approved
  •   317/14 (MPG §23b), Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  •   U1111-1170-0285 
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Health Condition or Problem studied

  •   K05.3 -  Chronic periodontitis
  •   Chronic marginal periodontitis
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Interventions/Observational Groups

  •   Treatment of a periodontal pocket of at least 5 mm probing depth with an ultra sonic device for 20 sec. Microbiological out of the pocket are taken beforte and after treatment. Controles are set after 3 and after 6t months. At the appointment of the 3 month control the participants receive PTC. Pockets of persisting increased depth are re-treated.
  •   Treatment of a periodontal pockets of at least 5 mm probing depth with trehalose powder. The powder is applicated for 20 sec via air-polishing. Microbiological out of the pocket are taken beforte and after treatment. Controles are set after 3 and after 6t months. At the appointment of the 3 month control the participants receive PTC. Pockets of persisting increased depth are re-treated.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   investigator/therapist, assessor
  •   Active control (effective treament of control group)
  •   Treatment
  •   Other
  •   N/A
  •   No
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Primary Outcome

attachment gain after 3 months

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Secondary Outcome

reduction of pocket probing depth, reduction of bleeding on probing (BOP), decrease of clinically healthy periodontal sites in percent (probing depth ≤ 4mm, no bleeding) from baseline to 3 months after treatment and to 6 months after treatment.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2015/06/15
  •   50
  •   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

Two one-rooted teeth in the same jaw in different quadrants; probing depth at least 6mm or 5mm with BOP; no intake of antibiotics during the last 3 months; last systematic periodontitis therapy within the last 2 years

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Exclusion Criteria

Probing depths under 6mm; several-rooted teeth; probing depth at least 6mm or 5mm with BOP; intake of antibiotics during the last 3 months; last systematic periodontitis therapy more than 2 years ago

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Orochemie GmbH + Co KG
    • Mr.  Dr.  Frank  Zimmermann 
    • Max-Planck-Str. 27
    • 70806  Kornwestheim
    • Germany
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    • Klinik für Zahnerhaltungskunde und Parodontologie, Department für Zahn-, Mund- und Kieferheilkunde, Uniklinik Freiburg
    • Ms.  Prof. Dr.  Petra  Ratka-Krüger 
    • Hugstetter Str. 5579106
    • 79106  Freiburg
    • Germany
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    • Klinik für Zahnerhaltungskunde und Parodontologie, Department für Zahn-, Mund- und Kieferheilkunde, Uniklinik Freiburg
    • Mr.  Dr.  Johan Peter  Wölber 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Orochemie GmbH + Co KG
    • Mr.  Dr.  Frank  Zimmermann 
    • Max-Planck-Str. 27
    • 70806  Kornwestheim
    • Germany
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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.