Impact of Pycnogenol® on Gingival Inflammation

Periodontitis Clinical Trial

— PINEGIN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05786820
• Other study ID #: PINEGIN_Protocol 1.7 - 17-7-21
• Status: Recruiting
• Phase: N/A
• Start date: March 17, 2022
• Est. completion date: March 1, 2024

Study information

• Verified date: April 2023
• Source: Wuerzburg University Hospital
• Contact: Yvonne Jockel-Schneider, Prof. Dr.
• Phone: 49-931-201
• Email: jockel_y[@]ukw.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: March 1, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Gingivitis
• Inflammation
• Periodontitis

Intervention

Dietary Supplement:
• Pycnogenol
daily consumption of a pycnogenol-containing capsule
• Placebo
Daily consumption of a placebo capsule

Locations

Country	Name	City	State
Germany	Dept. of Periodontology, Center for Oral Health	Wuerzburg

Sponsors (2)

Lead Sponsor	Collaborator
Wuerzburg University Hospital	University of Wuerzburg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months
Secondary	Gingival Index GI	Gingival Index will be recorded visually according to the modification of the original GI.	6 months
Secondary	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.	6 months
Secondary	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	6 months
Secondary	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	6 months
Secondary	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.	6 months
Secondary	Change in salivary polyphenol concentration	Saliva samples for the analysis of salivary polyphenols levels are taken at baseline and at 3 months	3 months
Secondary	Change in polyphenol serum concentration	Blood samples for the analysis of polyphenol serum levels are taken at baseline and at 3 months	3 months
Secondary	Change in salivary levels of cytokines, cytokine inhibitors, matrix metalloproteinases and MMP inhibitors	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.	6 months
Secondary	Change in serum levels of cytokines, cytokine inhibitors, matrix metalloproteinases and MMP inhibitors	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.	6 months
Secondary	Change in pulse wave velocity	Pulse wave velocity (m/sec) is measured at baseline and at 3 months	3 months
Secondary	Change in central aortal pulse pressure	Central aortal pulse pressure (mmHg) is measured at baseline and at 3 months	3 months
Secondary	Change in peripheral systolic and diastolic blood pressure	Peripheral systolic and diastolic blood pressure (mmHg) is measured at baseline and at 3 months.	3 months