Nitrate Consumption and Gingival Inflammation (NITGIN14)

Wuerzburg University Hospital

Status: Completed

Conditions: Gingivitis

Treatments: Dietary Supplement: nitrate-rich lettuce juice; Dietary Supplement: nitrate-depleted lettuce juice

Study type: Interventional

Funder types: Other

Identifiers

NCT05866341

NITGIN14

Details and patient eligibility

About

The aim of this investigation is to evaluate the impact of the 14- day consumption of a nitrate-rich diet on the the extent of gingival inflammation in a cohort of periodontal aftercare patients. Recorded parameters were gingival index, plaque control record, salivary nitrate/nitrite level and vascular parameters

Full description

This investigation evaluated the impact of a nitrate-rich diet on the extent of gingival inflammation in a cohort of periodontal aftercare patients. Forty-four (23 test/21 placebo) periodontal aftercare patients with chronic gingivitis were enrolled. At baseline, gingival index (GI), plaque con- trol record (PCR) and salivary nitrate level (SNL) were recorded, followed by sub- and supragingival debridement. Subsequently, participants were randomly provided with 100 ml bottles of a lettuce juice beverage to be consumed 39 daily over 14 days, containing either a standardized amount of nitrate resulting in an intake of approximately 200 mg nitrate per day (test) or being devoid of nitrate (placebo).

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• number of teeth ≥ 10
• body mass index (BMI) ≥ 24 ≤ 30
• presence of mild to moderate gingivitis (Gingiva Index > category GI 0 ≤ category GI 2) at a minimum of 3 teeth
• history of periodontal disease and inclusion in a regular scheme of supportive periodontal therapy (regularly repeated subgingival biofilm removal 2-4 x/year)

Exclusion criteria

• manifestation of severe gingivitis (Gingiva Index = 3) at any tooth
• manifestation of inflammatory oral mucosal diseases other than gingivitis
• xerostomia (salivary flow ≤ 0.1 ml/minute)
• inability for regular oral home care
• known allergies and intolerances to any of the ingredients of the experimental juice beverages
• inability to follow the study protocol due to intellectual or physical handicaps

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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44 participants in 2 patient groups, including a placebo group

Nitrate-rich Diet

Active Comparator group

Description:

Daily consumption of 200 mg nitrate via the consumption of 300 mL of a nitrate-rich lettuce juice beverage.

Treatment:

Dietary Supplement: nitrate-rich lettuce juice

Nitrate-depleted Diet

Placebo Comparator group

Description:

Daily consumption of 300 mL of a nitrate-depleted lettuce juice beverage.

Treatment:

Dietary Supplement: nitrate-depleted lettuce juice