Herbal Pralines - Oral Health
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: verum pralines containing nitrate 3x day (200mg nitrate per day) |
Dietary Supplement: herbal nitrate Pralines with nitrate
consumption of herbal pralines with nitrate
|
| Placebo Comparator: placebo pralines without nitrate |
Dietary Supplement: herbal nitrate Pralines without nitrate
consumption of herbal pralines without nitrate
|
Outcome Measures
Primary Outcome Measures
- bleeding on probing (BoP) [baseline]
observed percentage of probing sites being positive for bleeding on probing
- bleeding on probing (BoP) [14 days]
observed percentage of probing sites being positive for bleeding on probing
- bleeding on probing (BoP) [28 days]
observed percentage of probing sites being positive for bleeding on probing
Secondary Outcome Measures
- composition of the oral microbiome (subgingival) [baseline]
microbial samples are taking from the tooth showing the highest number of BoP positive sites
- composition of the oral microbiome (subgingival) [day 14]
microbial samples are taking from the tooth showing the highest number of BoP positive sites
- composition of the oral microbiome (subgingival) [day 28]
microbial samples are taking from the tooth showing the highest number of BoP positive sites
- Plaque Control Record (PCR) according to O´Leary [Baseline]
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.
- Plaque Control Record (PCR) according to O´Leary [Day 14]
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.
- Plaque Control Record (PCR) according to O´Leary [Day 28]
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.
- Gingiva Index (GI) [Baseline]
Gingival Index will be assessed strictly visually on a categorial scale ranging from GI 0 to GI 3 according to the Lobene modification
- Gingiva Index (GI) [Day 14]
Gingival Index will be assessed strictly visually on a categorial scale ranging from GI 0 to GI 3 according to the Lobene modification
- Gingiva Index (GI) [Day 28]
Gingival Index will be assessed strictly visually on a categorial scale ranging from GI 0 to GI 3 according to the Lobene modification
- Pocket probing depth [Baseline]
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
- Pocket probing depth [Day 14]
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
- Pocket probing depth [Day 28]
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
- Periodontal inflamed surface area (PISA) mm2 [Day 28]
PISA will be calculated from Pocket probing depth (PPD) in mm, Gingival Recession (Rec) in mm and BoP
- Periodontal inflamed surface area (PISA) [Baseline]
PISA will be calculated from PPD, Rec and BoPPISA willl be calculated from Pocket probing depth (PPD), Gingival Recession (Rec) and BoP
- Periodontal inflamed surface area (PISA) [Day 14]
PISA will be calculated from Pocket probing depth (PPD), Gingival Recession (Rec) and BoP
- Short-term Sick Leave [baseline]
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
- Short-term Sick Leave [Day 14]
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
- Short-term Sick Leave [Day 28]
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
- Salivary nitrate levels [Baseline]
Salivary nitrate levels will be determined from the salivary samples by High-Performance Anion-Exchange Chromatography with Suppressed Conductivity Detection (HPAEC-CD).
- Salivary nitrate levels [Day 14]
Salivary nitrate levels will be determined from the salivary samples by High-Performance Anion-Exchange Chromatography with Suppressed Conductivity Detection (HPAEC-CD).
- Salivary nitrate levels [Day 28]
Salivary nitrate levels will be determined from the salivary samples by High-Performance Anion-Exchange Chromatography with Suppressed Conductivity Detection (HPAEC-CD).
- Salivary nitrite levels [Baseline]
Salivary nitrite levels will be determined from the salivary samples by High-Performance Anion-Exchange Chromatography with Suppressed Conductivity Detection (HPAEC-CD).
- Salivary nitrite levels [Day 14]
Salivary nitrite levels will be determined from the salivary samples by High-Performance Anion-Exchange Chromatography with Suppressed Conductivity Detection (HPAEC-CD).
- Salivary nitrite levels [Day 28]
Salivary nitrite levels will be determined from the salivary samples by High-Performance Anion-Exchange Chromatography with Suppressed Conductivity Detection (HPAEC-CD).
- saliva buffer capacity ( the ability of a buffer solution to resist a change in pH) [baseline]
buffer capacity will be assed by PHmeter datenloGGer-store
- saliva buffer capacity ( the ability of a buffer solution to resist a change in pH) [day14]
buffer capacity will be assed by PHmeter datenloGGer-store
- saliva buffer capacity ( the ability of a buffer solution to resist a change in pH) [day28]
buffer capacity will be assed by PHmeter datenloGGer-store
- saliva PH levels [baseline]
PH levels will be assed by PHmeter datenloGGer-store
- saliva PH levels [Day 14]
PH levels will be assed by PHmeter (PHM 230 S) datenloGGer-store
- saliva PH levels [Day 28]
PH levels will be assed by PHmeter (PHM 230 S) datenloGGer-store
- Bacteria relevant to caries in saliva [Baseline]
Bacteria relevant to caries are cultivated and counted
- Bacteria relevant to caries in saliva [Day 14]
Bacteria relevant to caries are cultivated and counted
- Bacteria relevant to caries in saliva [Day 28]
Bacteria relevant to caries are cultivated and counted
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | German Naval Medical Institute | Kronshagen | Germany | 24119 | |
| 2 | Section of Periodontology | Wuerzburg | Germany | D-97070 |
Sponsors and Collaborators
- Wuerzburg University Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NAVNIT_23