Trial document




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  DRKS00009888

Trial Description

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Title

Effect of an oral health optimized diet on the subgingival biofilm.

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The inflammation of the gums, the periodontium (periodontitis) and caries are widespread diseases. Aim of the study is to study the effect of a oral health optimised diet on the subgingival biofilm. This optimised diet mainly includes a low-glycemic, low processed diet which is rich in vitamins, antioxidants and fibres. The clincal examination aims to study oral, serological and microbiological parameters at baseline and after four weeks of dietary transition.

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Brief Summary in Scientific Language

The inflammation of the gums, the periodontium (periodontitis) and caries are widespread diseases. Besides oral hygiene, diet has an effect on immunological parameters and the oral biofilm. Aim of the study is to study the effect of a oral health optimised diet on the subgingival biofilm. This optimised diet mainly includes a low-glycemic, low processed diet which is rich in vitamins, antioxidants and fibres. The clincal examination aims to study oral parameters (periodontal and plaque indices), serological parameters (IL-6, hs-CRP, TNF-a) and microbiological parameters at baseline and after four weeks of dietary transition. Study hypothesis is that the composition of the subgingival biofilm will be influenced by such a dietary transition. The study is grounded on the results of a prior pilot study with n=15 participants.

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Organizational Data

  •   DRKS00009888
  •   2016/02/15
  •   [---]*
  •   yes
  •   Approved
  •   8/16, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   K05.1 -  Chronic gingivitis
  •   K05.3 -  Chronic periodontitis
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Interventions/Observational Groups

  •   n=15 participants change their diet to a low-carbohydrate, high-Vitamin C and Vitamin D, high Omega 3 fatty acid, high fiber and high antioxidant diet for 6 weeks.
  •   n=15 participants do not change their diet for 6 weeks.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   investigator/therapist, data analyst
  •   Control group receives no treatment
  •   Basic research/physiological study
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Change of the biofilm after 6 weeks of dietary change compared to baseline and the control group.

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Secondary Outcome

Change of clinical parameters (Plaque index, Gingiva index, probing depths, Attachmentlevel, Bleeding on probing) and serological change (hsCRP, TNF-a, IL-6, Adiponectin) after 6 weeks of dietary change compared to baseline and to the control group.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2016/09/01
  •   30
  •   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

Consent for participation, mainly carbohydrate-based diet, no interdental cleaning during the study, gingiva index (Löe & Silness) >0,5

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Exclusion Criteria

- moderate to severe chronic periodontitis or aggressive periodontitis (in case of a light chronic periodontitis, biofilm sampling will be performed only at probing depths <4mm).
- Smoking
- Infectious or life threatening diseases
- Intake of antibiotics < 6 months before or during the study
- drugs influencing the bleeding or the inflammation like anticoagulants, cortisone etc.
- pregnancy or breastfeeding

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Addresses

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    • Uniklinik Freiburg, Abteilung für Zahnerhaltungskunde und Parodontologie
    • Mr.  Dr.  Johan  Wölber 
    • Husgtetter Str. 55
    • 79106  Freiburg
    • Germany
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    • Uniklinik Freiburg, Abteilung für Zahnerhaltungskunde und Parodontologie
    • Mr.  Dr.  Johan  Wölber 
    • Husgtetter Str. 55
    • 79106  Freiburg
    • Germany
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    • Uniklinik Freiburg, Abteilung für Zahnerhaltungskunde und Parodontologie
    • Mr.  Dr.  Johan  Wölber 
    • Husgtetter Str. 55
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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    • Klinik für Zahnerhaltungskunde und Parodontologie, Universitätsklinikum Freiburg i.Br.
    • Mr.  Prof. Dr.  Elmar  Hellwig 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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    •   004976127049570
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Status

  •   Recruiting planned
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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.