Impact of Pycnogenol® on Gingival Inflammation (PINEGIN)

Wuerzburg University Hospital

Status: Completed

Conditions: Periodontitis

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Pycnogenol

Study type: Interventional

Funder types: Other

Identifiers

NCT05786820

PINEGIN_Protocol 1.7 - 17-7-21

Details and patient eligibility

About

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

Full 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

Enrollment: 90 patients

Sex: All

Ages: 35 to 90 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 2 patient groups, including a placebo group

Pycnogenol Group

Active Comparator group

Description:

Professional mechanical plaque removal + Pycnogenol capsule

Treatment:

Dietary Supplement: Pycnogenol

Placebo Group

Placebo Comparator group

Description:

Professional mechanical plaque removal + placebo capsule

Treatment:

Dietary Supplement: Placebo