Dietary Collagen Peptides and Periodontal Inflammation
Condition: Gingivitis
MeSH terms: Gingivitis; Inflammation
Study type: Interventional

Summary: 
      This randomized, double-blind, placebo-controlled 2-arm, parallel group clinical trial is
      designed to evaluate the impact of the regular consumption of collagen peptides on the
      clinical signs of gingival and periodontal inflammation in a cohort of patients suffering
      from periodontal disease.
    

Detailed description: 
      The positive influence of the regular consumption of bioactive collagen peptides on
      connective tissue and skin physiology has already been documented by several clinical trials.
      Preliminary data of an observational clinical trial involving periodontitis patients suggest
      that the adjunctive consumption of bio-active collagen peptides may also improve the outcome
      of established periodontitis therapy comprising the professional mechanical removal of
      disease-associated bacterial biofilms from exposed root surfaces.

      This randomized, double-blind, placebo-controlled 2-arm, parallel group clinical trial is
      designed to evaluate the impact of the regular, 3-month consumption of collagen peptides on
      clinical and microbiological parameter of periodontal health in a cohort of periodontal
      recall patients with the following endpoints:

      Primary Endpoint:

      Change in the percentage of periodontal pockets being positive for bleeding on probing (BoP)
      after the consumption of the collagen peptides in comparison to the consumption of a placebo
      product

      Secondary Endpoints:

        1. changes in probing pocket depth (PPD)

        2. changes in clinical attachment level (CAL)

        3. changes in the periodontal inflammatory load as assessed by the calculation of the
           periodontal inflamed surface area (PISA) index

        4. changes in Gingival Index (GI) scores

        5. changes in Plaque Control Record (PCR) scores

        6. changes in Plaque Index scores

        7. changes in the composition of the sulcular/pocket microbiota

        8. changes in the composition of the intestinal microbiota

      Examiner calibration is performed before the onset of the trial and is repeated in 8 weeks
      intervals throughout the trial.

      Sample Size Calculation As this is the first controlled clinical trial evaluating the impact
      of collagen peptide consumption on the extent of periodontal inflammation, sample size
      calculation is based on substitute data from preceding studies demonstrating an increase in
      tissue healing by up to 30%.

      With a given difference of 30% reduction in the number of bleeding periodontal pockets (BoP)
      and an assumed standard deviation of 30% , sample size calculation resulted in a minimum of
      19 subjects per group in order to be able to statistically verify differences with a power of
      80%, and p<0.05.

      Chi-square-test with maximum likelihood method will be used for the analysis of categorical
      variables, Mann-Whitney U-test will be used for the analysis of independent samples, and
      Wilcoxon signed rank test for the analysis of paired samples. The level of significance will
      be set to p≤0.05.

      Study patients will be recruited from periodontitis patients seeking routine periodontal
      maintenance care comprising professional mechanical plaque removal (PMPR) at the Dept. of
      Periodontology of the University Hospital Wuerzburg.

      At baseline prior to the performance of PMPR all above-mentioned study parameters will be
      recorded. Subsequently the study participants will be randomly assigned to the experimental
      groups (test/placebo) and a supply of the assigned product (test/placebo) will be given to
      them with the instruction to consume it 1 x daily for the 3-month duration of the trial.

      At 2 months (visit 2) and at 3 months (end of study) after the baseline examination all
      clinical and microbiological parameters will be reassessed.
    

Intervention name(s): collagen peptide test; collagen peptide placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Collagen peptides from bovine skin with an average molecular weight of approx. 2,000 g/mol. Average particle size is about 150 μm.; collagen peptide placebo
Other intervention name(s): collagen peptide placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized, double-blind, placebo-controlled 2-arm, parallel group
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: gingivitis; collagen peptide; plaque