Nitrate Consumption and Gingival Inflammation

Not Applicable

Completed

• Conditions: Gingivitis
• Interventions: Dietary Supplement: nitrate-rich lettuce juice; Dietary Supplement: nitrate-depleted lettuce juice

• Registration Number: NCT05866341
• Lead Sponsor: Wuerzburg University Hospital

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).

Study Timeline

• Study Start: 2014-08-01
• Primary Completion: 2014-11-30
• Study Completion: 2014-11-30
• Study First Submitted: 2023-04-26
• Study First Submitted QC: 2023-05-09
• Study First Posted: 2023-05-19
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-18
• Last Update Posted: 2023-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nitrate-rich Diet	nitrate-rich lettuce juice	Daily consumption of 200 mg nitrate via the consumption of 300 mL of a nitrate-rich lettuce juice beverage.
Nitrate-depleted Diet	nitrate-depleted lettuce juice	Daily consumption of 300 mL of a nitrate-depleted lettuce juice beverage.

Primary Outcome Measures

Name	Time	Method
Gingival Index	Day 14	Gingival Index will be recorded visually according to the modification of the original

Secondary Outcome Measures

Name	Time	Method
Peripheral blood pressure (systolic pressure, diastolic pressure)	Day 14	Analysis of peripheral blood pressure by pulse wave analysis using the Arteriograph recording system (TensioMed Ltd, Hungary, software 1.9.9.12).
Composition the oral microbiota	Day 14	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
Salivary nitrite level	Day 14	salivary nitrite level (SNIL) was determined in duplicate by high-performance anion-exchange chromatography with suppressed conductivity detection (HPAEC-CD)
Salivary nitrate level	Day 14	salivary nitrate level was determined in duplicate by high-performance anion-exchange chromatography with suppressed conductivity detection (HPAEC-CD)
Central blood pressure (systolic pressure, diastolic pressure)	Day 14	Analysis of central blood pressure by pulse wave analysis using the Arteriograph recording system (TensioMed Ltd, Hungary, software 1.9.9.12).