Herbal Pralines - Oral Health
- Conditions
- GingivitisPeriodontitis
- Interventions
- Dietary Supplement: herbal nitrate Pralines with nitrateDietary Supplement: herbal nitrate Pralines without nitrate
- Registration Number
- NCT06090851
- Lead Sponsor
- Wuerzburg University Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 44
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description verum herbal nitrate Pralines with nitrate pralines containing nitrate 3x day (200mg nitrate per day) placebo herbal nitrate Pralines without nitrate pralines without nitrate
- Primary Outcome Measures
Name Time Method bleeding on probing (BoP) 28 days observed percentage of probing sites being positive for bleeding on probing
- Secondary Outcome Measures
Name Time Method 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
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
composition of the oral microbiome (subgingival) day 28 microbial samples are taking from the tooth showing the highest number of BoP positive sites
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
saliva PH levels Day 28 PH levels will be assed by PHmeter (PHM 230 S) datenloGGer-store
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.
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) Day 14 PISA will be calculated from Pocket probing depth (PPD), Gingival Recession (Rec) and BoP
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).
Bacteria relevant to caries in saliva Day 28 Bacteria relevant to caries are cultivated and counted
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
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).
Trial Locations
- Locations (2)
Section of Periodontology
🇩🇪Wuerzburg, Germany
German Naval Medical Institute
🇩🇪Kronshagen, Germany