Clinical trial NCT05866341: Nitrate Consumption and Gingival Inflammation
Official title: Influence of the Regular Consumption of a Nitrate Containing Juice Beverage on Gingival Inflammation and the Salivary Nitrate/Nitrite Relationship in Periodontitis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingivitis
Lead sponsor: Wuerzburg University Hospital
Sponsor class: OTHER
First posted: 2023-05-19
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: double blind randomized prospective placebo-controlled
Primary purpose: TREATMENT

Brief summary: 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

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Gingival Index
timeFrame: Baseline
measure: Gingival Index
timeFrame: Day 14
Secondary outcomes:
measure: Composition the oral microbiota
timeFrame: Baseline
measure: Composition the oral microbiota
timeFrame: Day 14
measure: Salivary nitrite level
timeFrame: Baseline
measure: Salivary nitrite level
timeFrame: Day 14
measure: Salivary nitrate level
timeFrame: Baseline
measure: Salivary nitrate level
timeFrame: Day 14
measure: Central blood pressure (systolic pressure, diastolic pressure)
timeFrame: Baseline
measure: Central blood pressure (systolic pressure, diastolic pressure)
timeFrame: Day 14
measure: Peripheral blood pressure (systolic pressure, diastolic pressure)
timeFrame: Baseline
measure: Peripheral blood pressure (systolic pressure, diastolic pressure)
timeFrame: Day 14
Other outcomes:
Locations:
Study officials:
References: