Gingivitis
Conditions
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).
Interventions
DIETARY_SUPPLEMENTnitrate-depleted lettuce juice
Daily consumption of 300 ml of a nitrate-depleted lettuce juice
DIETARY_SUPPLEMENTnitrate-rich lettuce juice
Consumption of a daily dosage of 200 mg nitrate via the consumption of a 300mö of a nitrate-rich lettuce juice
Sponsors
Wuerzburg University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Patients were allocated using a computer-generated randomization list in blocks of six either to the test or the placebo group. Assignment to a participant number was done according to the chronological order of enrolment in the study. All therapeutic and diagnostic interventions were performed at the Department of Periodontology of the University Hospital of Wuerzburg. All examinations were performed by two experienced, inter- and intra-calibrated periodontists not being involved in patient assignment and hand out of the experimental juices respectively.
Intervention model description
double blind randomized prospective placebo-controlled
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gingival Index | Baseline | Gingival Index will be recorded visually according to the modification of the original GI by Lobene et al. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Composition the oral microbiota | Baseline | 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 | Baseline | salivary nitrite level (SNIL) was determined in duplicate by high-performance anion-exchange chromatography with suppressed conductivity detection (HPAEC-CD) |
| Salivary nitrate level | Baseline | 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) | Baseline | Analysis of central blood pressure by pulse wave analysis using the Arteriograph recording system (TensioMed Ltd, Hungary, software 1.9.9.12). |
| Peripheral blood pressure (systolic pressure, diastolic pressure) | Baseline | Analysis of peripheral blood pressure by pulse wave analysis using the Arteriograph recording system (TensioMed Ltd, Hungary, software 1.9.9.12). |
Outcome results
None listed