Nitrate Consumption and Gingival Inflammation

Gingivitis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05866341
• Other study ID #: NITGIN14
• Status: Completed
• Phase: N/A
• Start date: August 1, 2014
• Est. completion date: November 30, 2014

Study information

• Verified date: September 2023
• Source: Wuerzburg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: November 30, 2014
• Est. primary completion date: November 30, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gingivitis
• Inflammation

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wuerzburg University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gingival Index	Gingival Index will be recorded visually according to the modification of the original GI by Lobene et al.	Baseline
Primary	Gingival Index	Gingival Index will be recorded visually according to the modification of the original	Day 14
Secondary	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	Baseline
Secondary	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	Day 14
Secondary	Salivary nitrite level	salivary nitrite level (SNIL) was determined in duplicate by high-performance anion-exchange chromatography with suppressed conductivity detection (HPAEC-CD)	Baseline
Secondary	Salivary nitrite level	salivary nitrite level (SNIL) was determined in duplicate by high-performance anion-exchange chromatography with suppressed conductivity detection (HPAEC-CD)	Day 14
Secondary	Salivary nitrate level	salivary nitrate level was determined in duplicate by high-performance anion-exchange chromatography with suppressed conductivity detection (HPAEC-CD)	Baseline
Secondary	Salivary nitrate level	salivary nitrate level was determined in duplicate by high-performance anion-exchange chromatography with suppressed conductivity detection (HPAEC-CD)	Day 14
Secondary	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).	Baseline
Secondary	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).	Day 14
Secondary	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).	Baseline
Secondary	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).	Day 14