Clinical trial NCT05786820: Impact of Pycnogenol® on Gingival Inflammation
Official title: Impact of a Dietary Supplementation With Maritime Pine Bark Extract (Pycnogenol®) on Gingival Inflammation - a Randomized Clinical Trial (PINEGIN)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontitis
Lead sponsor: Wuerzburg University Hospital
Sponsor class: OTHER
Collaborators: name: University of Wuerzburg
First posted: 2023-03-28
Enrollment: 90
Sex: ALL
Minimum age (years): 35
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized, double-blind, placebo-controlled 2-arm, parallel group clinical trial
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Bleeding on Probing (BoP)
timeFrame: 6 months
Secondary outcomes:
measure: Gingival Index GI
timeFrame: 6 months
measure: Plaque Control Record (PlaCR)
timeFrame: 6 months
measure: Compositional changes within the intestinal microbiota
timeFrame: 6 months
measure: Compositional changes within the oral microbiota
timeFrame: 6 months
measure: Change in periodontally inflamed surface area (PISA)
timeFrame: 6 months
measure: Change in salivary polyphenol concentration
timeFrame: 3 months
measure: Change in polyphenol serum concentration
timeFrame: 3 months
measure: Change in salivary levels of cytokines, cytokine inhibitors, matrix metalloproteinases and MMP inhibitors
timeFrame: 6 months
measure: Change in serum levels of cytokines, cytokine inhibitors, matrix metalloproteinases and MMP inhibitors
timeFrame: 6 months
measure: Change in pulse wave velocity
timeFrame: 3 months
measure: Change in central aortal pulse pressure
timeFrame: 3 months
measure: Change in peripheral systolic and diastolic blood pressure
timeFrame: 3 months
Other outcomes:
Locations:
city: Wuerzburg
country: Germany
facility: Dept. of Periodontology, Center for Oral Health
Study officials:
References: