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PeriodontitisPINEGINNCT05786820

Impact of Pycnogenol® on Gingival Inflammation

A study testing Pycnogenol in people with Periodontitis, run by Wuerzburg University Hospital at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 35 to 90 years
Conditions the study is for
Periodontitis
What is being tested?
Pycnogenol
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
90 participants
Where
1 siteGermany
Study dates
17 Mar 2022to 20 Jul 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Dept. of Periodontology, Center for Oral Health

    Würzburg, 97070

Other trials in Germany

About this study

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

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

Read the 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

Conditions
Periodontitis
Being tested
Pycnogenol, Placebo
Medical subject headings
Periodontitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PycnogenolDietary supplement

    Also called Maritime pine bark extract

    daily consumption of a pycnogenol-containing capsule

  • PlaceboDietary supplement

    Daily consumption of a placebo capsule

Study groups in NCT05786820
Study groupRoleWhat they receive
Pycnogenol GroupActive comparatorProfessional mechanical plaque removal + Pycnogenol capsule
Receives: Dietary Supplement: Pycnogenol
Placebo GroupPlacebo comparatorProfessional mechanical plaque removal + placebo capsule
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 months

Secondary outcomes (12)

  1. Gingival Index GI

    Gingival Index will be recorded visually according to the modification of the original GI.

    Measured: 6 months

  2. 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.

    Measured: 6 months

  3. 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

    Measured: 6 months

  4. 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

    Measured: 6 months

  5. 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.

    Measured: 6 months

  6. Change in salivary polyphenol concentration

    Saliva samples for the analysis of salivary polyphenols levels are taken at baseline and at 3 months

    Measured: 3 months

  7. Change in polyphenol serum concentration

    Blood samples for the analysis of polyphenol serum levels are taken at baseline and at 3 months

    Measured: 3 months

  8. 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.

    Measured: 6 months

  9. 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.

    Measured: 6 months

  10. Change in pulse wave velocity

    Pulse wave velocity (m/sec) is measured at baseline and at 3 months

    Measured: 3 months

  11. Change in central aortal pulse pressure

    Central aortal pulse pressure (mmHg) is measured at baseline and at 3 months

    Measured: 3 months

  12. Change in peripheral systolic and diastolic blood pressure

    Peripheral systolic and diastolic blood pressure (mmHg) is measured at baseline and at 3 months.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Mar 2023
  2. Study start17 Mar 2022
  3. Primary completion20 Jul 2024
  4. Study completion20 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
randomized, double-blind, placebo-controlled 2-arm, parallel group clinical trial
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05786820
Sponsor's protocol ID
PINEGIN_Protocol 1.7 - 17-7-21
Acronym
PINEGIN
Status last verified
Aug 2024
First submitted
19 Dec 2022
Last updated
9 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 40362854

Questions about this trial

What is this clinical trial studying?

A study testing Pycnogenol in people with Periodontitis, run by Wuerzburg University Hospital at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bleeding on Probing (BoP) (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05786820, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.

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