Herbal Pralines - Oral Health

Wuerzburg University Hospital

Status: Completed

Conditions: Periodontitis; Gingivitis

Treatments: Dietary Supplement: herbal nitrate Pralines without nitrate; Dietary Supplement: herbal nitrate Pralines with nitrate

Study type: Interventional

Funder types: Other

Identifiers

NCT06090851

NAVNIT_23

Details and patient eligibility

About

This randomized, double-blinded, placebo-controlled two-arm, parallel group clinical trial is designed to evaluate the impact of the consumption of two herbal pralines containing 200 mg nitrate on clinical signs of gingival inflammation (Bleeding on probing) without an accompanied professional mechanical plaque removal.

Enrollment: 44 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age 18 to 65 years,
• minimum of 20 % of the measure points showing a manifest bleeding after probing,
• no periodontal maintenance therapy within the past 4 months,
• a minimum of 10 remaining natural teeth

Exclusion criteria

• history of drug / alcohol abuse,
• systemic intake of antibiotics < 6 months prior to the study period,
• regular use of anti-inflammatory drugs,
• regular use of antibacterial mouthwashes,
• known allergic reactions to any ingredient in the experimental pralines
• mean arterial blood pressure MAD <80mmHg
• known allergies and intolerances to any of the ingredients of the experimental pralines

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

44 participants in 2 patient groups, including a placebo group

verum

Active Comparator group

Description:

pralines containing nitrate 3x day (200mg nitrate per day)

Treatment:

Dietary Supplement: herbal nitrate Pralines with nitrate

placebo

Placebo Comparator group

Description:

pralines without nitrate

Treatment:

Dietary Supplement: herbal nitrate Pralines without nitrate