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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
44
consumption of herbal pralines with nitrate
consumption of herbal pralines without nitrate
German Naval Medical Institute
Kronshagen, Germany
Section of Periodontology
Würzburg, Germany
bleeding on probing (BoP)
observed percentage of probing sites being positive for bleeding on probing
Time frame: baseline
bleeding on probing (BoP)
observed percentage of probing sites being positive for bleeding on probing
Time frame: 14 days
bleeding on probing (BoP)
observed percentage of probing sites being positive for bleeding on probing
Time frame: 28 days
composition of the oral microbiome (subgingival)
microbial samples are taking from the tooth showing the highest number of BoP positive sites
Time frame: baseline
composition of the oral microbiome (subgingival)
microbial samples are taking from the tooth showing the highest number of BoP positive sites
Time frame: day 14
composition of the oral microbiome (subgingival)
microbial samples are taking from the tooth showing the highest number of BoP positive sites
Time frame: 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.
Time frame: 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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline
Periodontal inflamed surface area (PISA)
PISA will be calculated from Pocket probing depth (PPD), Gingival Recession (Rec) and BoP
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: day28
saliva PH levels
PH levels will be assed by PHmeter datenloGGer-store
Time frame: baseline
saliva PH levels
PH levels will be assed by PHmeter (PHM 230 S) datenloGGer-store
Time frame: Day 14
saliva PH levels
PH levels will be assed by PHmeter (PHM 230 S) datenloGGer-store
Time frame: Day 28
Bacteria relevant to caries in saliva
Bacteria relevant to caries are cultivated and counted
Time frame: Baseline
Bacteria relevant to caries in saliva
Bacteria relevant to caries are cultivated and counted
Time frame: Day 14
Bacteria relevant to caries in saliva
Bacteria relevant to caries are cultivated and counted
Time frame: Day 28