Herbal Pralines - Oral Health
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
1 other identifier
interventional
44
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2023
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 15, 2023
CompletedFirst Submitted
Initial submission to the registry
September 18, 2023
CompletedFirst Posted
Study publicly available on registry
October 19, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2024
CompletedJuly 24, 2024
July 1, 2024
4 months
September 18, 2023
July 23, 2024
Conditions
Outcome Measures
Primary Outcomes (3)
bleeding on probing (BoP)
observed percentage of probing sites being positive for bleeding on probing
baseline
bleeding on probing (BoP)
observed percentage of probing sites being positive for bleeding on probing
14 days
bleeding on probing (BoP)
observed percentage of probing sites being positive for bleeding on probing
28 days
Secondary Outcomes (33)
composition of the oral microbiome (subgingival)
baseline
composition of the oral microbiome (subgingival)
day 14
composition of the oral microbiome (subgingival)
day 28
Plaque Control Record (PCR) according to O´Leary
Baseline
Plaque Control Record (PCR) according to O´Leary
Day 14
- +28 more secondary outcomes
Study Arms (2)
verum
ACTIVE COMPARATORpralines containing nitrate 3x day (200mg nitrate per day)
placebo
PLACEBO COMPARATORpralines without nitrate
Interventions
consumption of herbal pralines with nitrate
consumption of herbal pralines without nitrate
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
German Naval Medical Institute
Kronshagen, 24119, Germany
Section of Periodontology
Würzburg, D-97070, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof.Dr.
Study Record Dates
First Submitted
September 18, 2023
First Posted
October 19, 2023
Study Start
September 15, 2023
Primary Completion
December 31, 2023
Study Completion
January 31, 2024
Last Updated
July 24, 2024
Record last verified: 2024-07