Nitrate Consumption and Gingival Inflammation

NCT05866341 | Completed

• 1 other identifier: NITGIN14
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

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

Conditions

Gingivitis

Outcome Measures

Primary Outcomes (2)

• Gingival Index

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

  Baseline

• Gingival Index

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

  Day 14

Secondary Outcomes (10)

• Composition the oral microbiota

  Baseline

• Composition the oral microbiota

  Day 14

• Salivary nitrite level

  Baseline

• Salivary nitrite level

  Day 14

• Salivary nitrate level

  Baseline

Study Arms (2)

Nitrate-rich Diet

ACTIVE COMPARATOR

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

Nitrate-depleted Diet

PLACEBO COMPARATOR

Daily consumption of 300 mL of a nitrate-depleted lettuce juice beverage.

Dietary Supplement: nitrate-depleted lettuce juice

Interventions

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-rich Diet

nitrate-depleted lettuce juice DIETARY_SUPPLEMENT

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

Nitrate-depleted Diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wuerzburg University Hospital: lead

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med. dent.

Model Details: double blind randomized prospective placebo-controlled

Study Record Dates

• First Submitted: April 26, 2023
• First Posted: May 19, 2023
• Study Start: August 1, 2014
• Primary Completion: November 30, 2014
• Study Completion: November 30, 2014
• Last Updated: September 21, 2023

Record last verified: 2023-09