Gingivitis, Periodontitis
Conditions
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.
Interventions
DIETARY_SUPPLEMENTherbal nitrate Pralines with nitrate
consumption of herbal pralines with nitrate
DIETARY_SUPPLEMENTherbal nitrate Pralines without nitrate
consumption of herbal pralines without nitrate
Sponsors
Wuerzburg University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| bleeding on probing (BoP) | baseline | observed percentage of probing sites being positive for bleeding on probing |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| 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 |
| 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 |
| composition of the oral microbiome (subgingival) | baseline | microbial samples are taking from the tooth showing the highest number of BoP positive sites |
| 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 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). |
| 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 PH levels | baseline | PH levels will be assed by PHmeter datenloGGer-store |
| Bacteria relevant to caries in saliva | Baseline | Bacteria relevant to caries are cultivated and counted |
| 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 |
Countries
Germany
Outcome results
None listed