Clinical trial NCT06090851: Herbal Pralines - Oral Health
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontitis
Gingivitis
Lead sponsor: Wuerzburg University Hospital
Sponsor class: OTHER
First posted: 2023-10-19
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: bleeding on probing (BoP)
timeFrame: baseline
measure: bleeding on probing (BoP)
timeFrame: 14 days
measure: bleeding on probing (BoP)
timeFrame: 28 days
Secondary outcomes:
measure: composition of the oral microbiome (subgingival)
timeFrame: baseline
measure: composition of the oral microbiome (subgingival)
timeFrame: day 14
measure: composition of the oral microbiome (subgingival)
timeFrame: day 28
measure: Plaque Control Record (PCR) according to O´Leary
timeFrame: Baseline
measure: Plaque Control Record (PCR) according to O´Leary
timeFrame: Day 14
measure: Plaque Control Record (PCR) according to O´Leary
timeFrame: Day 28
measure: Gingiva Index (GI)
timeFrame: Baseline
measure: Gingiva Index (GI)
timeFrame: Day 14
measure: Gingiva Index (GI)
timeFrame: Day 28
measure: Pocket probing depth
timeFrame: Baseline
measure: Pocket probing depth
timeFrame: Day 14
measure: Pocket probing depth
timeFrame: Day 28
measure: Periodontal inflamed surface area (PISA) mm2
timeFrame: Day 28
measure: Periodontal inflamed surface area (PISA)
timeFrame: Baseline
measure: Periodontal inflamed surface area (PISA)
timeFrame: Day 14
measure: Short-term Sick Leave
timeFrame: baseline
measure: Short-term Sick Leave
timeFrame: Day 14
measure: Short-term Sick Leave
timeFrame: Day 28
measure: Salivary nitrate levels
timeFrame: Baseline
measure: Salivary nitrate levels
timeFrame: Day 14
measure: Salivary nitrate levels
timeFrame: Day 28
measure: Salivary nitrite levels
timeFrame: Baseline
measure: Salivary nitrite levels
timeFrame: Day 14
measure: Salivary nitrite levels
timeFrame: Day 28
measure: saliva buffer capacity ( the ability of a buffer solution to resist a change in pH)
timeFrame: baseline
measure: saliva buffer capacity ( the ability of a buffer solution to resist a change in pH)
timeFrame: day14
measure: saliva buffer capacity ( the ability of a buffer solution to resist a change in pH)
timeFrame: day28
measure: saliva PH levels
timeFrame: baseline
measure: saliva PH levels
timeFrame: Day 14
measure: saliva PH levels
timeFrame: Day 28
measure: Bacteria relevant to caries in saliva
timeFrame: Baseline
measure: Bacteria relevant to caries in saliva
timeFrame: Day 14
measure: Bacteria relevant to caries in saliva
timeFrame: Day 28
Other outcomes:
Locations:
city: Kronshagen
country: Germany
facility: German Naval Medical Institute
city: Wuerzburg
country: Germany
facility: Section of Periodontology
Study officials:
References: