Herbal Pralines - Oral Health

July 23, 2024 updated by: Dr. Yvonne Jockel-Schneider, Wuerzburg University Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
44

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Yvonne Jockel-Schneider, Prof
  • Phone Number: 004993120172570
  • Email: jockel_y@ukw.de

Study Contact Backup

Study Locations

  • Germany
      • Kronshagen, Germany, 24119
        • German Naval Medical Institute
      • Wuerzburg, Germany, D-97070
        • Section of Periodontology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: verum
pralines containing nitrate 3x day (200mg nitrate per day)
Dietary supplement: herbal nitrate Pralines with nitrate
consumption of herbal pralines with nitrate
Placebo Comparator: placebo
pralines without nitrate
Dietary supplement: herbal nitrate Pralines without nitrate
consumption of herbal pralines without nitrate

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
bleeding on probing (BoP)
Time Frame: baseline
observed percentage of probing sites being positive for bleeding on probing
baseline
bleeding on probing (BoP)
Time Frame: 14 days
observed percentage of probing sites being positive for bleeding on probing
14 days
bleeding on probing (BoP)
Time Frame: 28 days
observed percentage of probing sites being positive for bleeding on probing
28 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
composition of the oral microbiome (subgingival)
Time Frame: baseline
microbial samples are taking from the tooth showing the highest number of BoP positive sites
baseline
composition of the oral microbiome (subgingival)
Time Frame: day 14
microbial samples are taking from the tooth showing the highest number of BoP positive sites
day 14
composition of the oral microbiome (subgingival)
Time Frame: day 28
microbial samples are taking from the tooth showing the highest number of BoP positive sites
day 28
Plaque Control Record (PCR) according to O´Leary
Time Frame: 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.
Baseline
Plaque Control Record (PCR) according to O´Leary
Time Frame: Day 14
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.
Day 14
Plaque Control Record (PCR) according to O´Leary
Time Frame: 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.
Day 28
Gingiva Index (GI)
Time Frame: Baseline
Gingival Index will be assessed strictly visually on a categorial scale ranging from GI 0 to GI 3 according to the Lobene modification
Baseline
Gingiva Index (GI)
Time Frame: Day 14
Gingival Index will be assessed strictly visually on a categorial scale ranging from GI 0 to GI 3 according to the Lobene modification
Day 14
Gingiva Index (GI)
Time Frame: 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
Day 28
Pocket probing depth
Time Frame: 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
Baseline
Pocket probing depth
Time Frame: Day 14
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
Day 14
Pocket probing depth
Time Frame: 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
Day 28
Periodontal inflamed surface area (PISA) mm2
Time Frame: Day 28
PISA will be calculated from Pocket probing depth (PPD) in mm, Gingival Recession (Rec) in mm and BoP
Day 28
Periodontal inflamed surface area (PISA)
Time Frame: Baseline
PISA will be calculated from PPD, Rec and BoPPISA willl be calculated from Pocket probing depth (PPD), Gingival Recession (Rec) and BoP
Baseline
Periodontal inflamed surface area (PISA)
Time Frame: Day 14
PISA will be calculated from Pocket probing depth (PPD), Gingival Recession (Rec) and BoP
Day 14
Short-term Sick Leave
Time Frame: 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
baseline
Short-term Sick Leave
Time Frame: Day 14
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
Day 14
Short-term Sick Leave
Time Frame: 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
Day 28
Salivary nitrate levels
Time Frame: Baseline
Salivary nitrate levels will be determined from the salivary samples by High-Performance Anion-Exchange Chromatography with Suppressed Conductivity Detection (HPAEC-CD).
Baseline
Salivary nitrate levels
Time Frame: Day 14
Salivary nitrate levels will be determined from the salivary samples by High-Performance Anion-Exchange Chromatography with Suppressed Conductivity Detection (HPAEC-CD).
Day 14
Salivary nitrate levels
Time Frame: Day 28
Salivary nitrate levels will be determined from the salivary samples by High-Performance Anion-Exchange Chromatography with Suppressed Conductivity Detection (HPAEC-CD).
Day 28
Salivary nitrite levels
Time Frame: Baseline
Salivary nitrite levels will be determined from the salivary samples by High-Performance Anion-Exchange Chromatography with Suppressed Conductivity Detection (HPAEC-CD).
Baseline
Salivary nitrite levels
Time Frame: Day 14
Salivary nitrite levels will be determined from the salivary samples by High-Performance Anion-Exchange Chromatography with Suppressed Conductivity Detection (HPAEC-CD).
Day 14
Salivary nitrite levels
Time Frame: Day 28
Salivary nitrite levels will be determined from the salivary samples by High-Performance Anion-Exchange Chromatography with Suppressed Conductivity Detection (HPAEC-CD).
Day 28
saliva buffer capacity ( the ability of a buffer solution to resist a change in pH)
Time Frame: baseline
buffer capacity will be assed by PHmeter datenloGGer-store
baseline
saliva buffer capacity ( the ability of a buffer solution to resist a change in pH)
Time Frame: day14
buffer capacity will be assed by PHmeter datenloGGer-store
day14
saliva buffer capacity ( the ability of a buffer solution to resist a change in pH)
Time Frame: day28
buffer capacity will be assed by PHmeter datenloGGer-store
day28
saliva PH levels
Time Frame: baseline
PH levels will be assed by PHmeter datenloGGer-store
baseline
saliva PH levels
Time Frame: Day 14
PH levels will be assed by PHmeter (PHM 230 S) datenloGGer-store
Day 14
saliva PH levels
Time Frame: Day 28
PH levels will be assed by PHmeter (PHM 230 S) datenloGGer-store
Day 28
Bacteria relevant to caries in saliva
Time Frame: Baseline
Bacteria relevant to caries are cultivated and counted
Baseline
Bacteria relevant to caries in saliva
Time Frame: Day 14
Bacteria relevant to caries are cultivated and counted
Day 14
Bacteria relevant to caries in saliva
Time Frame: Day 28
Bacteria relevant to caries are cultivated and counted
Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wuerzburg University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 15, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 18, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 18, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 19, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 24, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NAVNIT_23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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