Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
90 participants
INTERVENTIONAL
2022-03-17
2024-07-20
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Pycnogenol Group
Professional mechanical plaque removal + Pycnogenol capsule
Pycnogenol
daily consumption of a pycnogenol-containing capsule
Placebo Group
Professional mechanical plaque removal + placebo capsule
Placebo
Daily consumption of a placebo capsule
Interventions
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Pycnogenol
daily consumption of a pycnogenol-containing capsule
Placebo
Daily consumption of a placebo capsule
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
35 Years
90 Years
ALL
No
Sponsors
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University of Wuerzburg
OTHER
Wuerzburg University Hospital
OTHER
Responsible Party
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Locations
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Dept. of Periodontology, Center for Oral Health
Würzburg, , Germany
Countries
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References
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Bayer J, Petersen NK, Hess JV, Jockel-Schneider Y, Hogger P. Impact of a Dietary Supplementation with French Maritime Pine Bark Extract Pycnogenol(R) on Salivary and Serum Inflammatory Biomarkers During Non-Surgical Periodontal Therapy-A Randomized Placebo-Controlled Double-Blind Trial. Nutrients. 2025 Apr 30;17(9):1546. doi: 10.3390/nu17091546.
Other Identifiers
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PINEGIN_Protocol 1.7 - 17-7-21
Identifier Type: -
Identifier Source: org_study_id
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