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Completed

NCT Number: NCT06090851

Herbal Pralines - Oral Health

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.

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Key information

Conditions

Periodontitis Gingival Diseases Gingivitis Infections Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

German Naval Medical Institute, Kronshagen, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

herbal nitrate Pralines with nitrate

Dietary Supplement

consumption of herbal pralines with nitrate

herbal nitrate Pralines without nitrate

Dietary Supplement

consumption of herbal pralines without nitrate

Primary outcomes

  1. bleeding on probing (BoP)

    Time frame: baseline

    observed percentage of probing sites being positive for bleeding on probing

  2. bleeding on probing (BoP)

    Time frame: 14 days

    observed percentage of probing sites being positive for bleeding on probing

  3. bleeding on probing (BoP)

    Time frame: 28 days

    observed percentage of probing sites being positive for bleeding on probing

Secondary outcomes

  1. composition of the oral microbiome (subgingival)

    Time frame: baseline

    microbial samples are taking from the tooth showing the highest number of BoP positive sites

  2. 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

  3. 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

  4. 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.

  5. 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.

  6. 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.

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. Periodontal inflamed surface area (PISA)

    Time frame: Day 14

    PISA will be calculated from Pocket probing depth (PPD), Gingival Recession (Rec) and BoP

  16. 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

  17. 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

  18. 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

  19. 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).

  20. 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).

  21. 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).

  22. 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).

  23. 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).

  24. 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).

  25. 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

  26. 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

  27. 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

  28. saliva PH levels

    Time frame: baseline

    PH levels will be assed by PHmeter datenloGGer-store

  29. saliva PH levels

    Time frame: Day 14

    PH levels will be assed by PHmeter (PHM 230 S) datenloGGer-store

  30. saliva PH levels

    Time frame: Day 28

    PH levels will be assed by PHmeter (PHM 230 S) datenloGGer-store

  31. Bacteria relevant to caries in saliva

    Time frame: Baseline

    Bacteria relevant to caries are cultivated and counted

  32. Bacteria relevant to caries in saliva

    Time frame: Day 14

    Bacteria relevant to caries are cultivated and counted

  33. Bacteria relevant to caries in saliva

    Time frame: Day 28

    Bacteria relevant to caries are cultivated and counted

Sponsors and collaborators

Lead sponsor

Wuerzburg University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Oct 19, 2023
Registry last updated
Jul 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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