Impact of Pycnogenol® on Gingival Inflammation
- Conditions
- Periodontitis
- Interventions
- Dietary Supplement: PlaceboDietary Supplement: Pycnogenol
- Registration Number
- NCT05786820
- Lead Sponsor
- Wuerzburg University Hospital
- Brief Summary
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
- Detailed Description
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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Group Placebo Professional mechanical plaque removal + placebo capsule Pycnogenol Group Pycnogenol Professional mechanical plaque removal + Pycnogenol capsule
- Primary Outcome Measures
Name Time Method Bleeding on Probing (BoP) 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 Outcome Measures
Name Time Method Change in central aortal pulse pressure 3 months Central aortal pulse pressure (mmHg) is measured at baseline and at 3 months
Change in polyphenol serum concentration 3 months Blood samples for the analysis of polyphenol serum levels are taken at baseline and at 3 months
Change in salivary levels of cytokines, cytokine inhibitors, matrix metalloproteinases and MMP inhibitors 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.
Change in peripheral systolic and diastolic blood pressure 3 months Peripheral systolic and diastolic blood pressure (mmHg) is measured at baseline and at 3 months.
Compositional changes within the intestinal microbiota 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
Compositional changes within the oral microbiota 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
Change in salivary polyphenol concentration 3 months Saliva samples for the analysis of salivary polyphenols levels are taken at baseline and at 3 months
Change in pulse wave velocity 3 months Pulse wave velocity (m/sec) is measured at baseline and at 3 months
Gingival Index GI 6 months Gingival Index will be recorded visually according to the modification of the original GI.
Plaque Control Record (PlaCR) 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.
Change in periodontally inflamed surface area (PISA) 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.
Change in serum levels of cytokines, cytokine inhibitors, matrix metalloproteinases and MMP inhibitors 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.
Trial Locations
- Locations (1)
Dept. of Periodontology, Center for Oral Health
🇩🇪Wuerzburg, Germany