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Completed

NCT Number: NCT05786820

Impact of Pycnogenol® on Gingival Inflammation

This randomized, double-blind, placebo-controlled 2-arm, parallel group clinical trial is designed to evaluate the impact of the regular consumption of a polyphenol-containing Maritime Pine (Pinus pinaster) bark extract (Pycnogenol®) on clinical signs of gingival inflammation in a cohort of periodontal aftercare patients

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Key information

Conditions

Periodontitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

35 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dept. of Periodontology, Center for Oral Health

Würzburg, 97070, Germany

About this study

Polyphenols are natural compounds produced by plants that have various functions, such as defence against microbial pathogens or protection against UV light. Based on their antioxidant activity, a soothing or preventive effect of polyphenols on various inflammatory diseases has been suspected. There is evidence of an anti-inflammatory effect of polyphenols in manifest periodontitis as well as antibacterial properties of these compounds. In addition, it is discussed that dietary polyphenols intervene in mechanisms involved in the pathophysiology of arteriosclerotic changes and their progression.

This randomized, double-blind, placebo-controlled 2-arm, parallel group clinical trial is designed to evaluate the impact of the regular consumption of a polyphenol-containing Maritime Pine (Pinus pinaster) bark extract (Pycnogenol®) on clinical signs of gingival inflammation in a cohort of periodontal aftercare patients

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • number of teeth ≥ 10
  • age ≥ 35 ≤ 90 years
  • body mass index (BMI) ≥ 20 ≤ 30
  • history of periodontal disease and inclusion in a regular scheme of supportive periodontal therapy (regularly repeated subgingival biofilm removal 2-4 x/year)
  • minimum of 10% probing sites displaying bleeding on probing

Exclusion criteria

  • manifestation of inflammatory oral mucosal diseases other than gingivitis
  • xerostomia (stimulated salivary flow ≤ 0.1 ml/minute)
  • inability to perform regular oral home care
  • inability to follow the study protocol due to intellectual or physical handicaps
  • history of malignancy, radiotherapy, or chemotherapy for malignancy in the past 5 years
  • current pregnancy
  • acute infections such as HIV
  • manifestation of metabolic bone disease
  • use of antibiotics and/or anti-inflammatory medications within 4 weeks prior to screening.
  • current orthodontic therapy

Treatment and study plan

Pycnogenol

Dietary Supplement

daily consumption of a pycnogenol-containing capsule

Other names: Maritime pine bark extract

Placebo

Dietary Supplement

Daily consumption of a placebo capsule

Primary outcomes

  1. Bleeding on Probing (BoP)

    Time frame: 6 months

    Bleeding on Probing (BoP) is defined as the appearance of a bleeding spot within 30 seconds after gently probing the evaluated periodontal pocket by inserting the periodontal probe up to the probable bottom of the pocket.

Secondary outcomes

  1. Gingival Index GI

    Time frame: 6 months

    Gingival Index will be recorded visually according to the modification of the original GI.

  2. Plaque Control Record (PlaCR)

    Time frame: 6 months

    Plaque Control Record (PlaCR) is defined as the percentage of assessed supragingival tooth surfaces covered by bacterial plaque. The presence of bacterial plaque is visually assessed after staining the tooth surfaces with a plaque staining agent.

  3. Compositional changes within the intestinal microbiota

    Time frame: 6 months

    Compositional changes within the intestinal microbiota between baseline and end of the study are assessed by Next Generation Whole Genome Sequencing on a species level

  4. Compositional changes within the oral microbiota

    Time frame: 6 months

    Compositional changes within the oral microbiota between baseline and end of the study are assessed by Next Generation Whole Genome Sequencing on a species level

  5. Change in periodontally inflamed surface area (PISA)

    Time frame: 6 months

    PISA is calculated using the recorded pocket depths and bleeding on probing scores at each evaluated tooth at baseline and at the end of the trial at 6 months.

  6. Change in salivary polyphenol concentration

    Time frame: 3 months

    Saliva samples for the analysis of salivary polyphenols levels are taken at baseline and at 3 months

  7. Change in polyphenol serum concentration

    Time frame: 3 months

    Blood samples for the analysis of polyphenol serum levels are taken at baseline and at 3 months

  8. Change in salivary levels of cytokines, cytokine inhibitors, matrix metalloproteinases and MMP inhibitors

    Time frame: 6 months

    Saliva samples are taken at baseline and at the end of the study at 6 months for the analysis of salivary interleukin (IL) 1ß, IL-6, IL-8, IL-31, matrix metalloproteinase (MMP)-8, MMP-9, tissue inhibitor of metalloproteinase (TIMP)-1 and Histatin 5 levels.

  9. Change in serum levels of cytokines, cytokine inhibitors, matrix metalloproteinases and MMP inhibitors

    Time frame: 6 months

    Blood samples are taken at baseline and at the end of the study at 6 months for the analysis of serum interleukin (IL) 1ß, IL-6, IL-8, IL-31, matrix metalloproteinase (MMP)-8, MMP-9, and tissue inhibitor of metalloproteinase (TIMP)-1 levels.

  10. Change in pulse wave velocity

    Time frame: 3 months

    Pulse wave velocity (m/sec) is measured at baseline and at 3 months

  11. Change in central aortal pulse pressure

    Time frame: 3 months

    Central aortal pulse pressure (mmHg) is measured at baseline and at 3 months

  12. Change in peripheral systolic and diastolic blood pressure

    Time frame: 3 months

    Peripheral systolic and diastolic blood pressure (mmHg) is measured at baseline and at 3 months.

Sponsors and collaborators

Lead sponsor

Wuerzburg University Hospital

Other

Collaborators

  • University of Wuerzburg

Registry information

Official study title

Impact of a Dietary Supplementation With Maritime Pine Bark Extract (Pycnogenol®) on Gingival Inflammation - a Randomized Clinical Trial (PINEGIN)

Acronym: PINEGIN

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 28, 2023
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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