Nitrate Consumption and Gingival Inflammation (NITGIN14)

September 18, 2023 updated by: Dr. Yvonne Jockel-Schneider, Wuerzburg University Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Nitrate-rich Diet
Daily consumption of 200 mg nitrate via the consumption of 300 mL of a nitrate-rich lettuce juice beverage.
Dietary supplement: nitrate-rich lettuce juice
Consumption of a daily dosage of 200 mg nitrate via the consumption of a 300mö of a nitrate-rich lettuce juice
Placebo Comparator: Nitrate-depleted Diet
Daily consumption of 300 mL of a nitrate-depleted lettuce juice beverage.
Dietary supplement: nitrate-depleted lettuce juice
Daily consumption of 300 ml of a nitrate-depleted lettuce juice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gingival Index
Time Frame: Baseline
Gingival Index will be recorded visually according to the modification of the original GI by Lobene et al.
Baseline
Gingival Index
Time Frame: Day 14
Gingival Index will be recorded visually according to the modification of the original
Day 14

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline
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
Day 14
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)
Baseline
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)
Day 14
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)
Baseline
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)
Day 14
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).
Baseline
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).
Day 14
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).
Baseline
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).
Day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wuerzburg University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2014

Primary Completion (Actual)

November 30, 2014

Study Completion (Actual)

November 30, 2014

Study Registration Dates

First Submitted

April 26, 2023

First Submitted That Met QC Criteria

May 9, 2023

First Posted (Actual)

May 19, 2023

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 18, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NITGIN14

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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