search
Back to results

Impact of Pycnogenol® on Gingival Inflammation (PINEGIN)

Primary Purpose

Periodontitis

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Pycnogenol
Placebo
Sponsored by
Wuerzburg University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis

Eligibility Criteria

35 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dept. of Periodontology, Center for Oral HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Pycnogenol Group

Placebo Group

Arm Description

Professional mechanical plaque removal + Pycnogenol capsule

Professional mechanical plaque removal + placebo capsule

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Gingival Index GI
Gingival Index will be recorded visually according to the modification of the original GI.
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.
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
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
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.
Change in salivary polyphenol concentration
Saliva samples for the analysis of salivary polyphenols levels are taken at baseline and at 3 months
Change in polyphenol serum concentration
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
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 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.
Change in pulse wave velocity
Pulse wave velocity (m/sec) is measured at baseline and at 3 months
Change in central aortal pulse pressure
Central aortal pulse pressure (mmHg) is measured at baseline and at 3 months
Change in peripheral systolic and diastolic blood pressure
Peripheral systolic and diastolic blood pressure (mmHg) is measured at baseline and at 3 months.

Full Information

First Posted
December 19, 2022
Last Updated
April 27, 2023
Sponsor
Wuerzburg University Hospital
Collaborators
University of Wuerzburg
search

1. Study Identification

Unique Protocol Identification Number
NCT05786820
Brief Title
Impact of Pycnogenol® on Gingival Inflammation
Acronym
PINEGIN
Official Title
Impact of a Dietary Supplementation With Maritime Pine Bark Extract (Pycnogenol®) on Gingival Inflammation - a Randomized Clinical Trial (PINEGIN)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 17, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wuerzburg University Hospital
Collaborators
University of Wuerzburg

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized, double-blind, placebo-controlled 2-arm, parallel group clinical trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The experimental pine bark dietary supplement is packaged in neutral capsules, which are dispensed to the study patients in bottles with code labels.
Allocation
Randomized
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pycnogenol Group
Arm Type
Active Comparator
Arm Description
Professional mechanical plaque removal + Pycnogenol capsule
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
Professional mechanical plaque removal + placebo capsule
Intervention Type
Dietary Supplement
Intervention Name(s)
Pycnogenol
Other Intervention Name(s)
Maritime pine bark extract
Intervention Description
daily consumption of a pycnogenol-containing capsule
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Daily consumption of a placebo capsule
Primary Outcome Measure Information:
Title
Bleeding on Probing (BoP)
Description
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 Outcome Measure Information:
Title
Gingival Index GI
Description
Gingival Index will be recorded visually according to the modification of the original GI.
Time Frame
6 months
Title
Plaque Control Record (PlaCR)
Description
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
Title
Compositional changes within the intestinal microbiota
Description
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
Title
Compositional changes within the oral microbiota
Description
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
Title
Change in periodontally inflamed surface area (PISA)
Description
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
Title
Change in salivary polyphenol concentration
Description
Saliva samples for the analysis of salivary polyphenols levels are taken at baseline and at 3 months
Time Frame
3 months
Title
Change in polyphenol serum concentration
Description
Blood samples for the analysis of polyphenol serum levels are taken at baseline and at 3 months
Time Frame
3 months
Title
Change in salivary levels of cytokines, cytokine inhibitors, matrix metalloproteinases and MMP inhibitors
Description
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.
Time Frame
6 months
Title
Change in serum levels of cytokines, cytokine inhibitors, matrix metalloproteinases and MMP inhibitors
Description
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.
Time Frame
6 months
Title
Change in pulse wave velocity
Description
Pulse wave velocity (m/sec) is measured at baseline and at 3 months
Time Frame
3 months
Title
Change in central aortal pulse pressure
Description
Central aortal pulse pressure (mmHg) is measured at baseline and at 3 months
Time Frame
3 months
Title
Change in peripheral systolic and diastolic blood pressure
Description
Peripheral systolic and diastolic blood pressure (mmHg) is measured at baseline and at 3 months.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yvonne Jockel-Schneider, Prof. Dr.
Phone
49-931-201
Ext
-72570
Email
jockel_y@ukw.de
First Name & Middle Initial & Last Name or Official Title & Degree
Nicole Petersen
Phone
49-931-201
Ext
-72570
Email
petersen_n1@ukw.de
Facility Information:
Facility Name
Dept. of Periodontology, Center for Oral Health
City
Wuerzburg
ZIP/Postal Code
97070
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicole Petersen
Phone
0049-931-201
Ext
0049-931-201
Email
petersen_n1@ukw.de
First Name & Middle Initial & Last Name & Degree
Jeanine Hess, Dr.
Phone
0049-931-201
Ext
0049-931-201
Email
hess_j1@ukw.de

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Impact of Pycnogenol® on Gingival Inflammation

We'll reach out to this number within 24 hrs