Trial document




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  DRKS00017415

Trial Description

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Title

The use of Perisolv® and hyaluronic acid during scaling and root planing

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Trial Acronym

perisolv

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Treating periodontitis subgingival instrumentation using hand and ultrasonic instruments will be performed. In the test group perisolv and hyaluronic acid will be used additionally. The control group will be treated just via hand and ultrasonic instruments. The results will be compared clinically, via microbiology in the subgingival biofilm and via biomarker in the gingival crevicular fluid three and six months after subgingival instrumentation.

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Brief Summary in Scientific Language

During nonsurgical therapy of periodontitis in the test group perisolv and hyadent will be used during subgingival instrumentation respecting the recommentations of the manufacturer. In the control Group conventional scaling and root planing using Hand and ultrasonic instruments will be performed. The results of the therapy will be verified clinically (PD, AL, BOP), microbiologically (subgingival biofilm, periodontopathogenic bacteria) and biochemically (gingival crevicular fluid, IL-1beta, MMP-8). Statistical Analysis will be performed.

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Organizational Data

  •   DRKS00017415
  •   2019/06/03
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  •   yes
  •   Approved
  •   427/17-ek, Ethikkommission an der Medizinischen Fakultät der Universität Leipzig
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Secondary IDs

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Health Condition or Problem studied

  •   K05.3 -  Chronic periodontitis
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Interventions/Observational Groups

  •   Test group: scaling and root planing with instillation of perisolv for 30 seconds, after that instillation of hyadent.
  •   Control group: scaling and root planing with hand- and ultrasonic instruments.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, assessor, data analyst
  •   Placebo
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Improvement of probing depth, determined via manual periodontal probe at baseline as well as after three and six months.

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Secondary Outcome

Improvement of attachment Level, bleeding on probing as well as of microbiological and biochemical variables
Clinical variables are determined using a manual periodontal probe at baseline as well as after three and six months.
Attachment level and bleeding on probing are measured with manual periodontal probe.
Microbiological and biochemical variables are determined using PCR-kits at the same time points.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2019/05/20
  •   50
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   40   Years
  •   65   Years
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Additional Inclusion Criteria

- chronic Periodontitis, after active phase of the treatment of periodontitis
- minimum 16 natural teeth
- age between 40 and 65 years
- 2 – 8 sites with probing depth = 5 mm, 5 mm + BOP (Bleeding on Probing) positive, 4 mm + BOP positive, not at adjacent teeth, 6 mm at monoradicular teeth at the appointment of reevaluation of SRP (Scaling und Rootplanning), after active Phase of periodontal treatment or during supportive periodontal therapy

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Exclusion Criteria

- patients younger than 18 years
- Periodontitis in relation with systemic diseases
- intake of immunosuppressive or immunomodulating drugs
- intake of antibiotics within the last 3 months befoe the study
- gravidity or lactation
- cancer
- Smoking of more than 5 cigarettes per day
- allergy in relation to ingredients of the used products
- Special nutrition (e. g. vegane nutrition)

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Addresses

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    • Universität Leipzig, FB Parodontologie der Poliklinik für Zahnerhaltung und Parodontologie
    • Mr.  Univ.-Prof. Dr. Dr. h.c.  Holger  Jentsch 
    • Liebigstr. 12, Haus 1
    • 04105  Leipzig
    • Germany
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    • Universität Leipzig,FB Parodontologie der Poliklinik für Zahnerhaltung und Parodontologie
    • Mr.  Univ.-Prof. Dr. Dr. h.c.  Holger  Jentsch 
    • Liebigstr. 12, Haus 1
    • 04105  Leipzig
    • Germany
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    end of 1:1-Block address contact scientific-contact
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    • Universität Leipzig, FB Parodontologie der Poliklinik für Zahnerhaltung und Parodontologie
    • Mr.  Univ.-Prof. Dr. Dr. h.c.  Holger  Jentsch 
    • Liebigstr. 12, Haus 1
    • 04105  Leipzig
    • Germany
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Sources of Monetary or Material Support

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    • Regedent AG
    • Zollikerstr. 144
    • 8008  Zürich
    • Switzerland
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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