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Completed

NCT Number: NCT05866341

Nitrate Consumption and Gingival Inflammation

The aim of this investigation is to evaluate the impact of the 14- day consumption of a nitrate-rich diet on the the extent of gingival inflammation in a cohort of periodontal aftercare patients. Recorded parameters were gingival index, plaque control record, salivary nitrate/nitrite level and vascular parameters

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

This investigation evaluated the impact of a nitrate-rich diet on the extent of gingival inflammation in a cohort of periodontal aftercare patients. Forty-four (23 test/21 placebo) periodontal aftercare patients with chronic gingivitis were enrolled. At baseline, gingival index (GI), plaque con- trol record (PCR) and salivary nitrate level (SNL) were recorded, followed by sub- and supragingival debridement. Subsequently, participants were randomly provided with 100 ml bottles of a lettuce juice beverage to be consumed 39 daily over 14 days, containing either a standardized amount of nitrate resulting in an intake of approximately 200 mg nitrate per day (test) or being devoid of nitrate (placebo).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • number of teeth ≥ 10
  • body mass index (BMI) ≥ 24 ≤ 30
  • presence of mild to moderate gingivitis (Gingiva Index > category GI 0 ≤ category GI 2) at a minimum of 3 teeth
  • history of periodontal disease and inclusion in a regular scheme of supportive periodontal therapy (regularly repeated subgingival biofilm removal 2-4 x/year)

Exclusion criteria

  • manifestation of severe gingivitis (Gingiva Index = 3) at any tooth
  • manifestation of inflammatory oral mucosal diseases other than gingivitis
  • xerostomia (salivary flow ≤ 0.1 ml/minute)
  • inability for regular oral home care
  • known allergies and intolerances to any of the ingredients of the experimental juice beverages
  • inability to follow the study protocol due to intellectual or physical handicaps

Treatment and study plan

nitrate-rich lettuce juice

Dietary Supplement

Consumption of a daily dosage of 200 mg nitrate via the consumption of a 300mö of a nitrate-rich lettuce juice

nitrate-depleted lettuce juice

Dietary Supplement

Daily consumption of 300 ml of a nitrate-depleted lettuce juice

Primary outcomes

  1. Gingival Index

    Time frame: Baseline

    Gingival Index will be recorded visually according to the modification of the original GI by Lobene et al.

  2. Gingival Index

    Time frame: Day 14

    Gingival Index will be recorded visually according to the modification of the original

Secondary outcomes

  1. Composition the oral microbiota

    Time frame: Baseline

    The microbial composition of pooled paper point plaque samples taken from the 4 deepest periodontal pockets are assessed by 16 S Genome Sequencing on a genus level

  2. Composition the oral microbiota

    Time frame: Day 14

    The microbial composition of pooled paper point plaque samples taken from the 4 deepest periodontal pockets are assessed by 16 S Genome Sequencing on a genus level

  3. Salivary nitrite level

    Time frame: Baseline

    salivary nitrite level (SNIL) was determined in duplicate by high-performance anion-exchange chromatography with suppressed conductivity detection (HPAEC-CD)

  4. Salivary nitrite level

    Time frame: Day 14

    salivary nitrite level (SNIL) was determined in duplicate by high-performance anion-exchange chromatography with suppressed conductivity detection (HPAEC-CD)

  5. Salivary nitrate level

    Time frame: Baseline

    salivary nitrate level was determined in duplicate by high-performance anion-exchange chromatography with suppressed conductivity detection (HPAEC-CD)

  6. Salivary nitrate level

    Time frame: Day 14

    salivary nitrate level was determined in duplicate by high-performance anion-exchange chromatography with suppressed conductivity detection (HPAEC-CD)

  7. Central blood pressure (systolic pressure, diastolic pressure)

    Time frame: Baseline

    Analysis of central blood pressure by pulse wave analysis using the Arteriograph recording system (TensioMed Ltd, Hungary, software 1.9.9.12).

  8. Central blood pressure (systolic pressure, diastolic pressure)

    Time frame: Day 14

    Analysis of central blood pressure by pulse wave analysis using the Arteriograph recording system (TensioMed Ltd, Hungary, software 1.9.9.12).

  9. Peripheral blood pressure (systolic pressure, diastolic pressure)

    Time frame: Baseline

    Analysis of peripheral blood pressure by pulse wave analysis using the Arteriograph recording system (TensioMed Ltd, Hungary, software 1.9.9.12).

  10. Peripheral blood pressure (systolic pressure, diastolic pressure)

    Time frame: Day 14

    Analysis of peripheral blood pressure by pulse wave analysis using the Arteriograph recording system (TensioMed Ltd, Hungary, software 1.9.9.12).

Sponsors and collaborators

Lead sponsor

Wuerzburg University Hospital

Other

Registry information

Official study title

Influence of the Regular Consumption of a Nitrate Containing Juice Beverage on Gingival Inflammation and the Salivary Nitrate/Nitrite Relationship in Periodontitis Patients

Acronym: NITGIN14

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
May 19, 2023
Registry last updated
Sep 21, 2023

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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