Nitrate Consumption and Gingival Inflammation

Study Overview
=================
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).

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

Conditions
-----------------
Gingivitis

Intervention / Treatment
-----------------
* Dietary Supplement: nitrate-rich lettuce juice
* Dietary Supplement: nitrate-depleted lettuce juice


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: double blind randomized prospective placebo-controlled
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nitrate-rich Diet<br>Daily consumption of 200 mg nitrate via the consumption of 300 mL of a nitrate-rich lettuce juice beverage. | Dietary Supplement: nitrate-rich lettuce juice<br>* Consumption of a daily dosage of 200 mg nitrate via the consumption of a 300mö of a nitrate-rich lettuce juice<br>|
| Placebo Comparator: Nitrate-depleted Diet<br>Daily consumption of 300 mL of a nitrate-depleted lettuce juice beverage. | Dietary Supplement: nitrate-depleted lettuce juice<br>* Daily consumption of 300 ml of a nitrate-depleted lettuce juice<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gingival Index | Gingival Index will be recorded visually according to the modification of the original GI by Lobene et al. | Baseline | 
| Gingival Index | Gingival Index will be recorded visually according to the modification of the original | Day 14 | 

Secondary Outcome Measures

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