Herbal Pralines - Oral Health

Study Overview
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Brief Summary
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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.

Official Title
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Impact of the Daily Consumption of Herbal Pralines on Parameters of Oral Health in Crew Members of a Naval Ship at Sea - a Randomized Controlled Trial

Conditions
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Periodontitis, Gingivitis

Intervention / Treatment
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* Dietary Supplement: herbal nitrate Pralines with nitrate
* Dietary Supplement: herbal nitrate Pralines without nitrate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18 to 65 years, minimum of 20 % of the measure points showing a manifest bleeding after probing, no periodontal maintenance therapy within the past 4 months, a minimum of 10 remaining natural teeth Exclusion Criteria: history of drug / alcohol abuse, systemic intake of antibiotics < 6 months prior to the study period, regular use of anti-inflammatory drugs, regular use of antibacterial mouthwashes, known allergic reactions to any ingredient in the experimental pralines mean arterial blood pressure MAD <80mmHg known allergies and intolerances to any of the ingredients of the experimental pralines

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: verum<br>pralines containing nitrate 3x day (200mg nitrate per day) | Dietary Supplement: herbal nitrate Pralines with nitrate<br>* consumption of herbal pralines with nitrate<br>|
| Placebo Comparator: placebo<br>pralines without nitrate | Dietary Supplement: herbal nitrate Pralines without nitrate<br>* consumption of herbal pralines without nitrate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 |