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Herbal Pralines - Oral Health

Primary Purpose

Periodontitis, Gingivitis

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
herbal nitrate Pralines with nitrate
herbal nitrate Pralines without nitrate
Sponsored by
Wuerzburg University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • German Naval Medical InstituteRecruiting
  • Section of PeriodontologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

verum

placebo

Arm Description

pralines containing nitrate 3x day (200mg nitrate per day)

pralines without nitrate

Outcomes

Primary Outcome Measures

bleeding on probing (BoP)
observed percentage of probing sites being positive for bleeding on probing
bleeding on probing (BoP)
observed percentage of probing sites being positive for bleeding on probing
bleeding on probing (BoP)
observed percentage of probing sites being positive for bleeding on probing

Secondary Outcome Measures

composition of the oral microbiome (subgingival)
microbial samples are taking from the tooth showing the highest number of BoP positive sites
composition of the oral microbiome (subgingival)
microbial samples are taking from the tooth showing the highest number of BoP positive sites
composition of the oral microbiome (subgingival)
microbial samples are taking from the tooth showing the highest number of BoP positive sites
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.
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.
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.
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
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
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
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
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
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
Periodontal inflamed surface area (PISA) mm2
PISA will be calculated from Pocket probing depth (PPD) in mm, Gingival Recession (Rec) in mm and BoP
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
Periodontal inflamed surface area (PISA)
PISA will be calculated from Pocket probing depth (PPD), Gingival Recession (Rec) and BoP
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
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
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
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).
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).
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).
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).
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).
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).
saliva buffer capacity ( the ability of a buffer solution to resist a change in pH)
buffer capacity will be assed by PHmeter datenloGGer-store
saliva buffer capacity ( the ability of a buffer solution to resist a change in pH)
buffer capacity will be assed by PHmeter datenloGGer-store
saliva buffer capacity ( the ability of a buffer solution to resist a change in pH)
buffer capacity will be assed by PHmeter datenloGGer-store
saliva PH levels
PH levels will be assed by PHmeter datenloGGer-store
saliva PH levels
PH levels will be assed by PHmeter (PHM 230 S) datenloGGer-store
saliva PH levels
PH levels will be assed by PHmeter (PHM 230 S) datenloGGer-store
Bacteria relevant to caries in saliva
Bacteria relevant to caries are cultivated and counted
Bacteria relevant to caries in saliva
Bacteria relevant to caries are cultivated and counted
Bacteria relevant to caries in saliva
Bacteria relevant to caries are cultivated and counted

Full Information

First Posted
September 18, 2023
Last Updated
October 18, 2023
Sponsor
Wuerzburg University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06090851
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wuerzburg University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis, Gingivitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
verum
Arm Type
Active Comparator
Arm Description
pralines containing nitrate 3x day (200mg nitrate per day)
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
pralines without nitrate
Intervention Type
Dietary Supplement
Intervention Name(s)
herbal nitrate Pralines with nitrate
Intervention Description
consumption of herbal pralines with nitrate
Intervention Type
Dietary Supplement
Intervention Name(s)
herbal nitrate Pralines without nitrate
Intervention Description
consumption of herbal pralines without nitrate
Primary Outcome Measure Information:
Title
bleeding on probing (BoP)
Description
observed percentage of probing sites being positive for bleeding on probing
Time Frame
baseline
Title
bleeding on probing (BoP)
Description
observed percentage of probing sites being positive for bleeding on probing
Time Frame
14 days
Title
bleeding on probing (BoP)
Description
observed percentage of probing sites being positive for bleeding on probing
Time Frame
28 days
Secondary Outcome Measure Information:
Title
composition of the oral microbiome (subgingival)
Description
microbial samples are taking from the tooth showing the highest number of BoP positive sites
Time Frame
baseline
Title
composition of the oral microbiome (subgingival)
Description
microbial samples are taking from the tooth showing the highest number of BoP positive sites
Time Frame
day 14
Title
composition of the oral microbiome (subgingival)
Description
microbial samples are taking from the tooth showing the highest number of BoP positive sites
Time Frame
day 28
Title
Plaque Control Record (PCR) according to O´Leary
Description
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.
Time Frame
Baseline
Title
Plaque Control Record (PCR) according to O´Leary
Description
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.
Time Frame
Day 14
Title
Plaque Control Record (PCR) according to O´Leary
Description
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.
Time Frame
Day 28
Title
Gingiva Index (GI)
Description
Gingival Index will be assessed strictly visually on a categorial scale ranging from GI 0 to GI 3 according to the Lobene modification
Time Frame
Baseline
Title
Gingiva Index (GI)
Description
Gingival Index will be assessed strictly visually on a categorial scale ranging from GI 0 to GI 3 according to the Lobene modification
Time Frame
Day 14
Title
Gingiva Index (GI)
Description
Gingival Index will be assessed strictly visually on a categorial scale ranging from GI 0 to GI 3 according to the Lobene modification
Time Frame
Day 28
Title
Pocket probing depth
Description
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
Time Frame
Baseline
Title
Pocket probing depth
Description
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
Time Frame
Day 14
Title
Pocket probing depth
Description
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
Time Frame
Day 28
Title
Periodontal inflamed surface area (PISA) mm2
Description
PISA will be calculated from Pocket probing depth (PPD) in mm, Gingival Recession (Rec) in mm and BoP
Time Frame
Day 28
Title
Periodontal inflamed surface area (PISA)
Description
PISA will be calculated from PPD, Rec and BoPPISA willl be calculated from Pocket probing depth (PPD), Gingival Recession (Rec) and BoP
Time Frame
Baseline
Title
Periodontal inflamed surface area (PISA)
Description
PISA will be calculated from Pocket probing depth (PPD), Gingival Recession (Rec) and BoP
Time Frame
Day 14
Title
Short-term Sick Leave
Description
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
Time Frame
baseline
Title
Short-term Sick Leave
Description
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
Time Frame
Day 14
Title
Short-term Sick Leave
Description
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
Time Frame
Day 28
Title
Salivary nitrate levels
Description
Salivary nitrate levels will be determined from the salivary samples by High-Performance Anion-Exchange Chromatography with Suppressed Conductivity Detection (HPAEC-CD).
Time Frame
Baseline
Title
Salivary nitrate levels
Description
Salivary nitrate levels will be determined from the salivary samples by High-Performance Anion-Exchange Chromatography with Suppressed Conductivity Detection (HPAEC-CD).
Time Frame
Day 14
Title
Salivary nitrate levels
Description
Salivary nitrate levels will be determined from the salivary samples by High-Performance Anion-Exchange Chromatography with Suppressed Conductivity Detection (HPAEC-CD).
Time Frame
Day 28
Title
Salivary nitrite levels
Description
Salivary nitrite levels will be determined from the salivary samples by High-Performance Anion-Exchange Chromatography with Suppressed Conductivity Detection (HPAEC-CD).
Time Frame
Baseline
Title
Salivary nitrite levels
Description
Salivary nitrite levels will be determined from the salivary samples by High-Performance Anion-Exchange Chromatography with Suppressed Conductivity Detection (HPAEC-CD).
Time Frame
Day 14
Title
Salivary nitrite levels
Description
Salivary nitrite levels will be determined from the salivary samples by High-Performance Anion-Exchange Chromatography with Suppressed Conductivity Detection (HPAEC-CD).
Time Frame
Day 28
Title
saliva buffer capacity ( the ability of a buffer solution to resist a change in pH)
Description
buffer capacity will be assed by PHmeter datenloGGer-store
Time Frame
baseline
Title
saliva buffer capacity ( the ability of a buffer solution to resist a change in pH)
Description
buffer capacity will be assed by PHmeter datenloGGer-store
Time Frame
day14
Title
saliva buffer capacity ( the ability of a buffer solution to resist a change in pH)
Description
buffer capacity will be assed by PHmeter datenloGGer-store
Time Frame
day28
Title
saliva PH levels
Description
PH levels will be assed by PHmeter datenloGGer-store
Time Frame
baseline
Title
saliva PH levels
Description
PH levels will be assed by PHmeter (PHM 230 S) datenloGGer-store
Time Frame
Day 14
Title
saliva PH levels
Description
PH levels will be assed by PHmeter (PHM 230 S) datenloGGer-store
Time Frame
Day 28
Title
Bacteria relevant to caries in saliva
Description
Bacteria relevant to caries are cultivated and counted
Time Frame
Baseline
Title
Bacteria relevant to caries in saliva
Description
Bacteria relevant to caries are cultivated and counted
Time Frame
Day 14
Title
Bacteria relevant to caries in saliva
Description
Bacteria relevant to caries are cultivated and counted
Time Frame
Day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yvonne Jockel-Schneider, Prof
Phone
004993120172570
Email
jockel_y@ukw.de
First Name & Middle Initial & Last Name or Official Title & Degree
Ulrich Schlagenhauf, Prof
Phone
004993120172750
Email
schlagenha_u@ukw.de
Facility Information:
Facility Name
German Naval Medical Institute
City
Kronshagen
ZIP/Postal Code
24119
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juliane Rehder, Dentist
Email
JulianeRehder@bundeswehr.org
Facility Name
Section of Periodontology
City
Wuerzburg
ZIP/Postal Code
D-97070
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yvonne Jockel-Schneider, Dr.
Phone
49-931-201725
Ext
70
Email
jockel_y@ukw.de

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Herbal Pralines - Oral Health

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