Impact of Pycnogenol® on Gingival Inflammation

Wuerzburg University Hospital90 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Periodontitis

Interventions

PycnogenolDIETARY_SUPPLEMENT

daily consumption of a pycnogenol-containing capsule

PlaceboDIETARY_SUPPLEMENT

Daily consumption of a placebo capsule

Eligibility

Sex: ALLMin age: 35 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

Dept. of Periodontology, Center for Oral Health

Würzburg, Germany

Outcomes

Primary Outcomes

Bleeding on Probing (BoP)

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.

Time frame: 6 months

Secondary Outcomes

Gingival Index GI

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

Time frame: 6 months

Plaque Control Record (PlaCR)

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.

Time frame: 6 months

Compositional changes within the intestinal microbiota

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

Time frame: 6 months

Compositional changes within the oral microbiota

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

Time frame: 6 months

Change in periodontally inflamed surface area (PISA)

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.

Time frame: 6 months

Change in salivary polyphenol concentration

Data from ClinicalTrials.gov

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