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This randomized, double-blinded, placebo-controlled two-arm, parallel group clinical trial is designed to evaluate the impact of the consumption of two herbal pralines containing 200 mg nitrate on clinical signs of gingival inflammation (Bleeding on probing) without an accompanied professional mechanical plaque removal.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| verum | Active Comparator | pralines containing nitrate 3x day (200mg nitrate per day) |
|
| placebo | Placebo Comparator | pralines without nitrate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| herbal nitrate Pralines with nitrate | Dietary Supplement | consumption of herbal pralines with nitrate |
|
| Measure | Description | Time Frame |
|---|---|---|
| bleeding on probing (BoP) | observed percentage of probing sites being positive for bleeding on probing | baseline |
| bleeding on probing (BoP) | observed percentage of probing sites being positive for bleeding on probing | 14 days |
| bleeding on probing (BoP) | observed percentage of probing sites being positive for bleeding on probing | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| composition of the oral microbiome (subgingival) | microbial samples are taking from the tooth showing the highest number of BoP positive sites | baseline |
| composition of the oral microbiome (subgingival) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| German Naval Medical Institute | Kronshagen | 24119 | Germany | |||
| Section of Periodontology |
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| ID | Term |
|---|---|
| D010518 | Periodontitis |
| D005891 | Gingivitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D009566 | Nitrates |
| ID | Term |
|---|---|
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D007287 | Inorganic Chemicals |
| D017942 |
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| herbal nitrate Pralines without nitrate | Dietary Supplement | consumption of herbal pralines without nitrate |
|
microbial samples are taking from the tooth showing the highest number of BoP positive sites
| day 14 |
| composition of the oral microbiome (subgingival) | microbial samples are taking from the tooth showing the highest number of BoP positive sites | day 28 |
| Plaque Control Record (PCR) according to O´Leary | The percentage of plaque coverage will calculated from the number of plaque-covered surfaces in relation to the number of all examined surfaces per tooth. | Baseline |
| Plaque Control Record (PCR) according to O´Leary | The percentage of plaque coverage will calculated from the number of plaque-covered surfaces in relation to the number of all examined surfaces per tooth. | Day 14 |
| Plaque Control Record (PCR) according to O´Leary | The percentage of plaque coverage will calculated from the number of plaque-covered surfaces in relation to the number of all examined surfaces per tooth. | Day 28 |
| Gingiva Index (GI) | Gingival Index will be assessed strictly visually on a categorial scale ranging from GI 0 to GI 3 according to the Lobene modification | Baseline |
| Gingiva Index (GI) | Gingival Index will be assessed strictly visually on a categorial scale ranging from GI 0 to GI 3 according to the Lobene modification | Day 14 |
| Gingiva Index (GI) | Gingival Index will be assessed strictly visually on a categorial scale ranging from GI 0 to GI 3 according to the Lobene modification | Day 28 |
| Pocket probing depth | The probable pocket depth (PPD) in mm will recorded using a PCP-11 Marquis periodontal probe (Hu-Friedy, USA) at six measuring points (mesio-buccal, buccal, disto-buccal, disto-oral, oral, mesio-oral) per tooth | Baseline |
| Pocket probing depth | The probable pocket depth (PPD)in mm will recorded using a PCP-11 Marquis periodontal probe (Hu-Friedy, USA) at six measuring points (mesio-buccal, buccal, disto-buccal, disto-oral, oral, mesio-oral) per tooth | Day 14 |
| Pocket probing depth | The probable pocket depth (PPD) in mm will recorded using a PCP-11 Marquis periodontal probe (Hu-Friedy, USA) at six measuring points (mesio-buccal, buccal, disto-buccal, disto-oral, oral, mesio-oral) per tooth | Day 28 |
| Periodontal inflamed surface area (PISA) mm2 | PISA will be calculated from Pocket probing depth (PPD) in mm, Gingival Recession (Rec) in mm and BoP | Day 28 |
| Periodontal inflamed surface area (PISA) | PISA will be calculated from PPD, Rec and BoPPISA willl be calculated from Pocket probing depth (PPD), Gingival Recession (Rec) and BoP | Baseline |
| Periodontal inflamed surface area (PISA) | PISA will be calculated from Pocket probing depth (PPD), Gingival Recession (Rec) and BoP | Day 14 |
| Short-term Sick Leave | The number of occasions a study participant consulted the onboard physician due to respiratory or gastrointestinal discomfort is documented via a questionnaire. Diagnoses reported by the study participants will be verified by the onboard physician | baseline |
| Short-term Sick Leave | The number of occasions a study participant consulted the onboard physician due to respiratory or gastrointestinal discomfort is documented via a questionnaire. Diagnoses reported by the study participants will be verified by the onboard physician | Day 14 |
| Short-term Sick Leave | The number of occasions a study participant consulted the onboard physician due to respiratory or gastrointestinal discomfort is documented via a questionnaire. Diagnoses reported by the study participants will be verified by the onboard physician | Day 28 |
| Salivary nitrate levels | Salivary nitrate levels will be determined from the salivary samples by High-Performance Anion-Exchange Chromatography with Suppressed Conductivity Detection (HPAEC-CD). | Baseline |
| Salivary nitrate levels | Salivary nitrate levels will be determined from the salivary samples by High-Performance Anion-Exchange Chromatography with Suppressed Conductivity Detection (HPAEC-CD). | Day 14 |
| Salivary nitrate levels | Salivary nitrate levels will be determined from the salivary samples by High-Performance Anion-Exchange Chromatography with Suppressed Conductivity Detection (HPAEC-CD). | Day 28 |
| Salivary nitrite levels | Salivary nitrite levels will be determined from the salivary samples by High-Performance Anion-Exchange Chromatography with Suppressed Conductivity Detection (HPAEC-CD). | Baseline |
| Salivary nitrite levels | Salivary nitrite levels will be determined from the salivary samples by High-Performance Anion-Exchange Chromatography with Suppressed Conductivity Detection (HPAEC-CD). | Day 14 |
| Salivary nitrite levels | Salivary nitrite levels will be determined from the salivary samples by High-Performance Anion-Exchange Chromatography with Suppressed Conductivity Detection (HPAEC-CD). | Day 28 |
| saliva buffer capacity ( the ability of a buffer solution to resist a change in pH) | buffer capacity will be assed by PHmeter datenloGGer-store | baseline |
| saliva buffer capacity ( the ability of a buffer solution to resist a change in pH) | buffer capacity will be assed by PHmeter datenloGGer-store | day14 |
| saliva buffer capacity ( the ability of a buffer solution to resist a change in pH) | buffer capacity will be assed by PHmeter datenloGGer-store | day28 |
| saliva PH levels | PH levels will be assed by PHmeter datenloGGer-store | baseline |
| saliva PH levels | PH levels will be assed by PHmeter (PHM 230 S) datenloGGer-store | Day 14 |
| saliva PH levels | PH levels will be assed by PHmeter (PHM 230 S) datenloGGer-store | Day 28 |
| Bacteria relevant to caries in saliva | Bacteria relevant to caries are cultivated and counted | Baseline |
| Bacteria relevant to caries in saliva | Bacteria relevant to caries are cultivated and counted | Day 14 |
| Bacteria relevant to caries in saliva | Bacteria relevant to caries are cultivated and counted | Day 28 |
| Würzburg |
| D-97070 |
| Germany |
| D005882 |
| Gingival Diseases |
| Nitric Acid |
| D017672 | Nitrogen Compounds |
| D009930 | Organic Chemicals |