Herbal Pralines - Oral Health

Periodontitis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06090851
• Other study ID #: NAVNIT_23
• Status: Recruiting
• Phase: N/A
• Start date: September 15, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: October 2023
• Source: Wuerzburg University Hospital
• Contact: Yvonne Jockel-Schneider, Prof
• Phone: 004993120172570
• Email: jockel_y[@]ukw.de
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 removal.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: June 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Gingivitis
• Periodontitis

Intervention

Dietary Supplement:
• herbal nitrate Pralines with nitrate
consumption of herbal pralines with nitrate
• herbal nitrate Pralines without nitrate
consumption of herbal pralines without nitrate

Locations

Country	Name	City	State
Germany	German Naval Medical Institute	Kronshagen
Germany	Section of Periodontology	Wuerzburg

Sponsors (1)

Lead Sponsor	Collaborator
Wuerzburg University Hospital

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bleeding on probing (BoP)	observed percentage of probing sites being positive for bleeding on probing	baseline
Primary	bleeding on probing (BoP)	observed percentage of probing sites being positive for bleeding on probing	14 days
Primary	bleeding on probing (BoP)	observed percentage of probing sites being positive for bleeding on probing	28 days
Secondary	composition of the oral microbiome (subgingival)	microbial samples are taking from the tooth showing the highest number of BoP positive sites	baseline
Secondary	composition of the oral microbiome (subgingival)	microbial samples are taking from the tooth showing the highest number of BoP positive sites	day 14
Secondary	composition of the oral microbiome (subgingival)	microbial samples are taking from the tooth showing the highest number of BoP positive sites	day 28
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Periodontal inflamed surface area (PISA)	PISA will be calculated from Pocket probing depth (PPD), Gingival Recession (Rec) and BoP	Day 14
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	saliva PH levels	PH levels will be assed by PHmeter datenloGGer-store	baseline
Secondary	saliva PH levels	PH levels will be assed by PHmeter (PHM 230 S) datenloGGer-store	Day 14
Secondary	saliva PH levels	PH levels will be assed by PHmeter (PHM 230 S) datenloGGer-store	Day 28
Secondary	Bacteria relevant to caries in saliva	Bacteria relevant to caries are cultivated and counted	Baseline
Secondary	Bacteria relevant to caries in saliva	Bacteria relevant to caries are cultivated and counted	Day 14
Secondary	Bacteria relevant to caries in saliva	Bacteria relevant to caries are cultivated and counted	Day 28