Back to resultsNitrate Consumption and Gingival Inflammation (NITGIN14)
Primary Purpose
Gingivitis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
nitrate-rich lettuce juice
nitrate-depleted lettuce juice
Sponsored by
About this trial
This is an interventional treatment trial for Gingivitis
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Nitrate-rich Diet
Nitrate-depleted Diet
Arm Description
Daily consumption of 200 mg nitrate via the consumption of 300 mL of a nitrate-rich lettuce juice beverage.
Daily consumption of 300 mL of a nitrate-depleted lettuce juice beverage.
Outcomes
Primary Outcome Measures
Gingival Index
Gingival Index will be recorded visually according to the modification of the original GI by Lobene et al.
Gingival Index
Gingival Index will be recorded visually according to the modification of the original
Secondary Outcome Measures
Composition the oral microbiota
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
Composition the oral microbiota
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
Salivary nitrite level
salivary nitrite level (SNIL) was determined in duplicate by high-performance anion-exchange chromatography with suppressed conductivity detection (HPAEC-CD)
Salivary nitrite level
salivary nitrite level (SNIL) was determined in duplicate by high-performance anion-exchange chromatography with suppressed conductivity detection (HPAEC-CD)
Salivary nitrate level
salivary nitrate level was determined in duplicate by high-performance anion-exchange chromatography with suppressed conductivity detection (HPAEC-CD)
Salivary nitrate level
salivary nitrate level was determined in duplicate by high-performance anion-exchange chromatography with suppressed conductivity detection (HPAEC-CD)
Central blood pressure (systolic pressure, diastolic pressure)
Analysis of central blood pressure by pulse wave analysis using the Arteriograph recording system (TensioMed Ltd, Hungary, software 1.9.9.12).
Central blood pressure (systolic pressure, diastolic pressure)
Analysis of central blood pressure by pulse wave analysis using the Arteriograph recording system (TensioMed Ltd, Hungary, software 1.9.9.12).
Peripheral blood pressure (systolic pressure, diastolic pressure)
Analysis of peripheral blood pressure by pulse wave analysis using the Arteriograph recording system (TensioMed Ltd, Hungary, software 1.9.9.12).
Peripheral blood pressure (systolic pressure, diastolic pressure)
Analysis of peripheral blood pressure by pulse wave analysis using the Arteriograph recording system (TensioMed Ltd, Hungary, software 1.9.9.12).
Full Information
NCT ID
NCT05866341
First Posted
April 26, 2023
Last Updated
September 18, 2023
Sponsor
Wuerzburg University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05866341
Brief Title
Nitrate Consumption and Gingival Inflammation
Acronym
NITGIN14
Official Title
Influence of the Regular Consumption of a Nitrate Containing Juice Beverage on Gingival Inflammation and the Salivary Nitrate/Nitrite Relationship in Periodontitis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2014 (Actual)
Primary Completion Date
November 30, 2014 (Actual)
Study Completion Date
November 30, 2014 (Actual)
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
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
Detailed Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingivitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
double blind randomized prospective placebo-controlled
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Patients were allocated using a computer-generated randomization list in blocks of six either to the test or the placebo group. Assignment to a participant number was done according to the chronological order of enrolment in the study. All therapeutic and diagnostic interventions were performed at the Department of Periodontology of the University Hospital of Wuerzburg. All examinations were performed by two experienced, inter- and intra-calibrated periodontists not being involved in patient assignment and hand out of the experimental juices respectively.
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nitrate-rich Diet
Arm Type
Active Comparator
Arm Description
Daily consumption of 200 mg nitrate via the consumption of 300 mL of a nitrate-rich lettuce juice beverage.
Arm Title
Nitrate-depleted Diet
Arm Type
Placebo Comparator
Arm Description
Daily consumption of 300 mL of a nitrate-depleted lettuce juice beverage.
Intervention Type
Dietary Supplement
Intervention Name(s)
nitrate-rich lettuce juice
Intervention Description
Consumption of a daily dosage of 200 mg nitrate via the consumption of a 300mö of a nitrate-rich lettuce juice
Intervention Type
Dietary Supplement
Intervention Name(s)
nitrate-depleted lettuce juice
Intervention Description
Daily consumption of 300 ml of a nitrate-depleted lettuce juice
Primary Outcome Measure Information:
Title
Gingival Index
Description
Gingival Index will be recorded visually according to the modification of the original GI by Lobene et al.
Time Frame
Baseline
Title
Gingival Index
Description
Gingival Index will be recorded visually according to the modification of the original
Time Frame
Day 14
Secondary Outcome Measure Information:
Title
Composition the oral microbiota
Description
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
Time Frame
Baseline
Title
Composition the oral microbiota
Description
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
Time Frame
Day 14
Title
Salivary nitrite level
Description
salivary nitrite level (SNIL) was determined in duplicate by high-performance anion-exchange chromatography with suppressed conductivity detection (HPAEC-CD)
Time Frame
Baseline
Title
Salivary nitrite level
Description
salivary nitrite level (SNIL) was determined in duplicate by high-performance anion-exchange chromatography with suppressed conductivity detection (HPAEC-CD)
Time Frame
Day 14
Title
Salivary nitrate level
Description
salivary nitrate level was determined in duplicate by high-performance anion-exchange chromatography with suppressed conductivity detection (HPAEC-CD)
Time Frame
Baseline
Title
Salivary nitrate level
Description
salivary nitrate level was determined in duplicate by high-performance anion-exchange chromatography with suppressed conductivity detection (HPAEC-CD)
Time Frame
Day 14
Title
Central blood pressure (systolic pressure, diastolic pressure)
Description
Analysis of central blood pressure by pulse wave analysis using the Arteriograph recording system (TensioMed Ltd, Hungary, software 1.9.9.12).
Time Frame
Baseline
Title
Central blood pressure (systolic pressure, diastolic pressure)
Description
Analysis of central blood pressure by pulse wave analysis using the Arteriograph recording system (TensioMed Ltd, Hungary, software 1.9.9.12).
Time Frame
Day 14
Title
Peripheral blood pressure (systolic pressure, diastolic pressure)
Description
Analysis of peripheral blood pressure by pulse wave analysis using the Arteriograph recording system (TensioMed Ltd, Hungary, software 1.9.9.12).
Time Frame
Baseline
Title
Peripheral blood pressure (systolic pressure, diastolic pressure)
Description
Analysis of peripheral blood pressure by pulse wave analysis using the Arteriograph recording system (TensioMed Ltd, Hungary, software 1.9.9.12).
Time Frame
Day 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Nitrate Consumption and Gingival Inflammation
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