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

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: Recruiting
• Conditions: Periodontitis; Gingivitis
• Intervention / Treatment: Dietary supplement: herbal nitrate Pralines with nitrate; Dietary supplement: herbal nitrate Pralines without nitrate

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yvonne Jockel-Schneider, Prof; Phone Number: 004993120172570; Email: jockel_y@ukw.de
• Study Contact Backup: Name: Ulrich Schlagenhauf, Prof; Phone Number: 004993120172750; Email: schlagenha_u@ukw.de

Study Locations

• Germany
  • Kronshagen, Germany, 24119
    • Recruiting
    • German Naval Medical Institute
    • Contact: Juliane Rehder, Dentist; Email: JulianeRehder@bundeswehr.org
  • Wuerzburg, Germany, D-97070
    • Recruiting
    • Section of Periodontology
    • Contact: Yvonne Jockel-Schneider, Dr.; Phone Number: 70 49-931-201725; Email: jockel_y@ukw.de

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
composition of the oral microbiome (subgingival)	microbial samples are taking from the tooth showing the highest number of BoP positive sites	baseline
composition of the oral microbiome (subgingival)	microbial samples are taking from the tooth showing the highest number of BoP positive sites	day 14
composition of the oral microbiome (subgingival)	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	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	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	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)	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)	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)	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	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	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	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	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)	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)	PISA will be calculated from Pocket probing depth (PPD), Gingival Recession (Rec) and BoP	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	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	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	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).	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).	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).	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).	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).	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).	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	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	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	day28
saliva PH levels	PH levels will be assed by PHmeter datenloGGer-store	baseline
saliva PH levels	PH levels will be assed by PHmeter (PHM 230 S) datenloGGer-store	Day 14
saliva PH levels	PH levels will be assed by PHmeter (PHM 230 S) datenloGGer-store	Day 28
Bacteria relevant to caries in saliva	Bacteria relevant to caries are cultivated and counted	Baseline
Bacteria relevant to caries in saliva	Bacteria relevant to caries are cultivated and counted	Day 14
Bacteria relevant to caries in saliva	Bacteria relevant to caries are cultivated and counted	Day 28

Collaborators and Investigators

• Sponsor: Wuerzburg University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2023
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: September 18, 2023
• First Submitted That Met QC Criteria: October 18, 2023
• First Posted (Actual): October 19, 2023

Study Record Updates

• Last Update Posted (Actual): October 19, 2023
• Last Update Submitted That Met QC Criteria: October 18, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Periodontitis; Gingivitis
• Other Study ID 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