Nitrate Consumption and Gingival Inflammation

Wuerzburg University Hospital44 enrolled

Overview

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

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Gingivitis

Interventions

nitrate-rich lettuce juiceDIETARY_SUPPLEMENT

Consumption of a daily dosage of 200 mg nitrate via the consumption of a 300mö of a nitrate-rich lettuce juice

nitrate-depleted lettuce juiceDIETARY_SUPPLEMENT

Daily consumption of 300 ml of a nitrate-depleted lettuce juice

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Gingival Index

Gingival Index will be recorded visually according to the modification of the original GI by Lobene et al.

Time frame: Baseline

Gingival Index

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

Time frame: Day 14

Secondary Outcomes

Composition the oral microbiota

The microbial composition of pooled paper point plaque samples taken from the 4 deepest periodontal pockets are assessed by 16 S Genome Sequencing on a genus level

Time frame: Baseline

Composition the oral microbiota

The microbial composition of pooled paper point plaque samples taken from the 4 deepest periodontal pockets are assessed by 16 S Genome Sequencing on a genus level

Time frame: Day 14

Salivary nitrite level

salivary nitrite level (SNIL) was determined in duplicate by high-performance anion-exchange chromatography with suppressed conductivity detection (HPAEC-CD)

Time frame: Baseline

Salivary nitrite level

salivary nitrite level (SNIL) was determined in duplicate by high-performance anion-exchange chromatography with suppressed conductivity detection (HPAEC-CD)

Time frame: Day 14

Salivary nitrate level

salivary nitrate level was determined in duplicate by high-performance anion-exchange chromatography with suppressed conductivity detection (HPAEC-CD)

Time frame: Baseline

Data from ClinicalTrials.gov

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