NITGIN14: Nitrate Consumption and Gingival Inflammation

Sponsor

Wuerzburg University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05866341

Collaborator

(none)

Enrollment

Arms

Actual Duration (Months)

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Gingivitis	Dietary Supplement: nitrate-rich lettuce juice Dietary Supplement: nitrate-depleted lettuce juice	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

double blind randomized prospective placebo-controlleddouble blind randomized prospective placebo-controlled

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes 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.

Primary Purpose:

Treatment

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

Actual Study Start Date :

Aug 1, 2014

Actual Primary Completion Date :

Nov 30, 2014

Actual Study Completion Date :

Nov 30, 2014

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Gingival Index [Baseline]
Gingival Index will be recorded visually according to the modification of the original GI by Lobene et al.
Gingival Index [Day 14]
Gingival Index will be recorded visually according to the modification of the original

Secondary Outcome Measures

Composition the oral microbiota [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
Composition the oral microbiota [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
Salivary nitrite level [Baseline]
salivary nitrite level (SNIL) was determined in duplicate by high-performance anion-exchange chromatography with suppressed conductivity detection (HPAEC-CD)
Salivary nitrite level [Day 14]
salivary nitrite level (SNIL) was determined in duplicate by high-performance anion-exchange chromatography with suppressed conductivity detection (HPAEC-CD)
Salivary nitrate level [Baseline]
salivary nitrate level was determined in duplicate by high-performance anion-exchange chromatography with suppressed conductivity detection (HPAEC-CD)
Salivary nitrate level [Day 14]
salivary nitrate level was determined in duplicate by high-performance anion-exchange chromatography with suppressed conductivity detection (HPAEC-CD)
Central blood pressure [Baseline]
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 [Day 14]
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 [Baseline]
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 [Day 14]
Analysis of peripheral blood pressure by pulse wave analysis using the Arteriograph recording system (TensioMed Ltd, Hungary, software 1.9.9.12).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Wuerzburg University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr. Yvonne Jockel-Schneider, Prof. Dr. med. dent., Wuerzburg University Hospital

ClinicalTrials.gov Identifier:

NCT05866341

Other Study ID Numbers:

NITGIN14

First Posted:

May 19, 2023

Last Update Posted:

May 19, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Gingivitis

Inflammation

Study Results

No Results Posted as of May 19, 2023