Impact of Pycnogenol® on Gingival Inflammation

NCT05786820 | Completed

• 1 other identifier: PINEGIN_Protocol 1.7 - 17-7-21
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Conditions

Periodontitis

Outcome Measures

Primary Outcomes (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.

  6 months

Secondary Outcomes (12)

• Gingival Index GI

  6 months

• Plaque Control Record (PlaCR)

  6 months

• Compositional changes within the intestinal microbiota

  6 months

• Compositional changes within the oral microbiota

  6 months

• Change in periodontally inflamed surface area (PISA)

  6 months

Study Arms (2)

Pycnogenol Group

ACTIVE COMPARATOR

Professional mechanical plaque removal + Pycnogenol capsule

Dietary Supplement: Pycnogenol

Placebo Group

PLACEBO COMPARATOR

Professional mechanical plaque removal + placebo capsule

Dietary Supplement: Placebo

Interventions

Pycnogenol DIETARY_SUPPLEMENT

daily consumption of a pycnogenol-containing capsule

Also known as: Maritime pine bark extract

Pycnogenol Group

Placebo DIETARY_SUPPLEMENT

Daily consumption of a placebo capsule

Placebo Group

Eligibility Criteria

• Age: 35 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• number of teeth ≥ 10
• age ≥ 35 ≤ 90 years
• body mass index (BMI) ≥ 20 ≤ 30
• minimum of 10% probing sites displaying bleeding on probing

You may not qualify if:

• 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

Sponsors & Collaborators

• Wuerzburg University Hospital: lead
• University of Wuerzburg: collaborator

Study Sites (1)

Dept. of Periodontology, Center for Oral Health

Würzburg, 97070, Germany

Location

Related Publications (1)

• 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.

  PMID: 40362854 DERIVED

MeSH Terms

Conditions

Periodontitis

Interventions

pycnogenols

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The experimental pine bark dietary supplement is packaged in neutral capsules, which are dispensed to the study patients in bottles with code labels.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized, double-blind, placebo-controlled 2-arm, parallel group clinical trial

Study Record Dates

• First Submitted: December 19, 2022
• First Posted: March 28, 2023
• Study Start: March 17, 2022
• Primary Completion: July 20, 2024
• Study Completion: July 20, 2024
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)