PeriodontitisNCT06090851
Herbal Pralines - Oral Health
A study testing herbal nitrate Pralines with nitrate and herbal nitrate Pralines without nitrate in people with Periodontitis and Gingivitis, run by Wuerzburg University Hospital at 2 sites in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Periodontitis, Gingivitis
- What is being tested?
- herbal nitrate Pralines with nitrate and herbal nitrate Pralines without nitrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 2 sitesGermany
- Study dates
- 15 Sep 2023to 31 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
German Naval Medical Institute
Kronshagen, 24119
Section of Periodontology
Würzburg, D-97070
About this study
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
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.
- Conditions
- Periodontitis, Gingivitis
- Being tested
- herbal nitrate Pralines with nitrate, herbal nitrate Pralines without nitrate
- Medical subject headings
- Periodontitis, Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
herbal nitrate Pralines with nitrateDietary supplement
consumption of herbal pralines with nitrate
herbal nitrate Pralines without nitrateDietary supplement
consumption of herbal pralines without nitrate
| Study group | Role | What they receive |
|---|---|---|
| verum | Active comparator | pralines containing nitrate 3x day (200mg nitrate per day) Receives: Dietary Supplement: herbal nitrate Pralines with nitrate |
| placebo | Placebo comparator | pralines without nitrate Receives: Dietary Supplement: herbal nitrate Pralines without nitrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
bleeding on probing (BoP)
observed percentage of probing sites being positive for bleeding on probing
Measured: baseline
bleeding on probing (BoP)
observed percentage of probing sites being positive for bleeding on probing
Measured: 14 days
bleeding on probing (BoP)
observed percentage of probing sites being positive for bleeding on probing
Measured: 28 days
Secondary outcomes (33)
composition of the oral microbiome (subgingival)
microbial samples are taking from the tooth showing the highest number of BoP positive sites
Measured: baseline
composition of the oral microbiome (subgingival)
microbial samples are taking from the tooth showing the highest number of BoP positive sites
Measured: day 14
composition of the oral microbiome (subgingival)
microbial samples are taking from the tooth showing the highest number of BoP positive sites
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline
Periodontal inflamed surface area (PISA)
PISA will be calculated from Pocket probing depth (PPD), Gingival Recession (Rec) and BoP
Measured: 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
Measured: 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
Measured: 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
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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
Measured: 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
Measured: 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
Measured: day28
saliva PH levels
PH levels will be assed by PHmeter datenloGGer-store
Measured: baseline
saliva PH levels
PH levels will be assed by PHmeter (PHM 230 S) datenloGGer-store
Measured: Day 14
saliva PH levels
PH levels will be assed by PHmeter (PHM 230 S) datenloGGer-store
Measured: Day 28
Bacteria relevant to caries in saliva
Bacteria relevant to caries are cultivated and counted
Measured: Baseline
Bacteria relevant to caries in saliva
Bacteria relevant to caries are cultivated and counted
Measured: Day 14
Bacteria relevant to caries in saliva
Bacteria relevant to caries are cultivated and counted
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study start15 Sep 2023
- Primary completion31 Dec 2023
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wuerzburg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Yvonne Jockel-Schneider, Wuerzburg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06090851
- Sponsor's protocol ID
- NAVNIT_23
- Status last verified
- Jul 2024
- First submitted
- 18 Sep 2023
- Last updated
- 24 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06090851
- Acronym / sponsor ID
- NAVNIT_23
- Conditions
- Periodontitis, Gingivitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Wuerzburg University HospitalUniversity, hospital or other
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 19 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| verum | Active comparator | Dietary Supplement: herbal nitrate Pralines with nitratepralines containing nitrate 3x day (200mg nitrate per day) |
| placebo | Placebo comparator | Dietary Supplement: herbal nitrate Pralines without nitratepralines without nitrate |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| herbal nitrate Pralines with nitrateconsumption of herbal pralines with nitrate | Dietary supplement | verum |
| herbal nitrate Pralines without nitrateconsumption of herbal pralines without nitrate | Dietary supplement | placebo |
Primary outcome
bleeding on probing (BoP)
Time frame: baseline
observed percentage of probing sites being positive for bleeding on probing
bleeding on probing (BoP)
Time frame: 14 days
observed percentage of probing sites being positive for bleeding on probing
bleeding on probing (BoP)
Time frame: 28 days
observed percentage of probing sites being positive for bleeding on probing
33 secondary outcomes
composition of the oral microbiome (subgingival)
Time frame: baseline
composition of the oral microbiome (subgingival)
Time frame: day 14
composition of the oral microbiome (subgingival)
Time frame: day 28
Plaque Control Record (PCR) according to O´Leary
Time frame: Baseline
Plaque Control Record (PCR) according to O´Leary
Time frame: Day 14
Plaque Control Record (PCR) according to O´Leary
Time frame: Day 28
Gingiva Index (GI)
Time frame: Baseline
Gingiva Index (GI)
Time frame: Day 14
Gingiva Index (GI)
Time frame: Day 28
Pocket probing depth
Time frame: Baseline
Pocket probing depth
Time frame: Day 14
Pocket probing depth
Time frame: Day 28
Periodontal inflamed surface area (PISA) mm2
Time frame: Day 28
Periodontal inflamed surface area (PISA)
Time frame: Baseline
Periodontal inflamed surface area (PISA)
Time frame: Day 14
Short-term Sick Leave
Time frame: baseline
Short-term Sick Leave
Time frame: Day 14
Short-term Sick Leave
Time frame: Day 28
Salivary nitrate levels
Time frame: Baseline
Salivary nitrate levels
Time frame: Day 14
Salivary nitrate levels
Time frame: Day 28
Salivary nitrite levels
Time frame: Baseline
Salivary nitrite levels
Time frame: Day 14
Salivary nitrite levels
Time frame: Day 28
saliva buffer capacity ( the ability of a buffer solution to resist a change in pH)
Time frame: baseline
saliva buffer capacity ( the ability of a buffer solution to resist a change in pH)
Time frame: day14
saliva buffer capacity ( the ability of a buffer solution to resist a change in pH)
Time frame: day28
saliva PH levels
Time frame: baseline
saliva PH levels
Time frame: Day 14
saliva PH levels
Time frame: Day 28
Bacteria relevant to caries in saliva
Time frame: Baseline
Bacteria relevant to caries in saliva
Time frame: Day 14
Bacteria relevant to caries in saliva
Time frame: Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing herbal nitrate Pralines with nitrate and herbal nitrate Pralines without nitrate in people with Periodontitis and Gingivitis, run by Wuerzburg University Hospital at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bleeding on probing (BoP) (time frame: baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2024.