GingivitisNITGIN14NCT05866341
Nitrate Consumption and Gingival Inflammation
A study testing nitrate-rich lettuce juice and nitrate-depleted lettuce juice in people with Gingivitis, run by Wuerzburg University Hospital.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gingivitis
- What is being tested?
- nitrate-rich lettuce juice and nitrate-depleted lettuce juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2014to 30 Nov 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
About this study
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
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
Read the 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).
- Conditions
- Gingivitis
- Being tested
- nitrate-rich lettuce juice, nitrate-depleted lettuce juice
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nitrate-rich lettuce juiceDietary supplement
Consumption of a daily dosage of 200 mg nitrate via the consumption of a 300mö of a nitrate-rich lettuce juice
nitrate-depleted lettuce juiceDietary supplement
Daily consumption of 300 ml of a nitrate-depleted lettuce juice
| Study group | Role | What they receive |
|---|---|---|
| Nitrate-rich Diet | Active comparator | Daily consumption of 200 mg nitrate via the consumption of 300 mL of a nitrate-rich lettuce juice beverage. Receives: Dietary Supplement: nitrate-rich lettuce juice |
| Nitrate-depleted Diet | Placebo comparator | Daily consumption of 300 mL of a nitrate-depleted lettuce juice beverage. Receives: Dietary Supplement: nitrate-depleted lettuce juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival Index
Gingival Index will be recorded visually according to the modification of the original GI by Lobene et al.
Measured: Baseline
Gingival Index
Gingival Index will be recorded visually according to the modification of the original
Measured: Day 14
Secondary outcomes (10)
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
Measured: Baseline
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
Measured: Day 14
Salivary nitrite level
salivary nitrite level (SNIL) was determined in duplicate by high-performance anion-exchange chromatography with suppressed conductivity detection (HPAEC-CD)
Measured: Baseline
Salivary nitrite level
salivary nitrite level (SNIL) was determined in duplicate by high-performance anion-exchange chromatography with suppressed conductivity detection (HPAEC-CD)
Measured: Day 14
Salivary nitrate level
salivary nitrate level was determined in duplicate by high-performance anion-exchange chromatography with suppressed conductivity detection (HPAEC-CD)
Measured: Baseline
Salivary nitrate level
salivary nitrate level was determined in duplicate by high-performance anion-exchange chromatography with suppressed conductivity detection (HPAEC-CD)
Measured: Day 14
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).
Measured: Baseline
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).
Measured: Day 14
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).
Measured: Baseline
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).
Measured: Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start1 Aug 2014
- Primary completion30 Nov 2014
- Study completion30 Nov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- double blind randomized prospective placebo-controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wuerzburg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Yvonne Jockel-Schneider, Wuerzburg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05866341
- Sponsor's protocol ID
- NITGIN14
- Acronym
- NITGIN14
- Status last verified
- Sep 2023
- First submitted
- 26 Apr 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05866341
- Acronym / sponsor ID
- NITGIN14 / NITGIN14
- Conditions
- Gingivitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Wuerzburg University HospitalUniversity, hospital or other
- Study start
- 1 Aug 2014 (actual)
- Primary completion
- 30 Nov 2014 (actual)
- Study completion
- 30 Nov 2014 (actual)
- First posted
- 19 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- double blind randomized prospective placebo-controlled
| Arm | Type | Receives |
|---|---|---|
| Nitrate-rich Diet | Active comparator | Dietary Supplement: nitrate-rich lettuce juiceDaily consumption of 200 mg nitrate via the consumption of 300 mL of a nitrate-rich lettuce juice beverage. |
| Nitrate-depleted Diet | Placebo comparator | Dietary Supplement: nitrate-depleted lettuce juiceDaily consumption of 300 mL of a nitrate-depleted lettuce juice beverage. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nitrate-rich lettuce juiceConsumption of a daily dosage of 200 mg nitrate via the consumption of a 300mö of a nitrate-rich lettuce juice | Dietary supplement | Nitrate-rich Diet |
| nitrate-depleted lettuce juiceDaily consumption of 300 ml of a nitrate-depleted lettuce juice | Dietary supplement | Nitrate-depleted Diet |
Primary outcome
Gingival Index
Time frame: Baseline
Gingival Index will be recorded visually according to the modification of the original GI by Lobene et al.
Gingival Index
Time frame: Day 14
Gingival Index will be recorded visually according to the modification of the original
10 secondary outcomes
Composition the oral microbiota
Time frame: Baseline
Composition the oral microbiota
Time frame: Day 14
Salivary nitrite level
Time frame: Baseline
Salivary nitrite level
Time frame: Day 14
Salivary nitrate level
Time frame: Baseline
Salivary nitrate level
Time frame: Day 14
Central blood pressure (systolic pressure, diastolic pressure)
Time frame: Baseline
Central blood pressure (systolic pressure, diastolic pressure)
Time frame: Day 14
Peripheral blood pressure (systolic pressure, diastolic pressure)
Time frame: Baseline
Peripheral blood pressure (systolic pressure, diastolic pressure)
Time frame: Day 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Gingivitis
Not yet recruiting
Effectiveness of Oil Pulling Using Oils in Comparison With Mouthwash for Gingivitis
Gingivitis
Active, not recruitingObservational study
Comparison of Saliva Characteristics and Oral Health in Pregnant and Non-pregnant Women
Plaque Induced Gingivitis
Not yet recruitingObservational study
Circadian Clock Proteins in Gingival Crevicular Fluid of Individuals With and Without Circadian Rhythm Disruption
Gingivitis, Circadian Rhythm Disruption
Not yet recruitingObservational study
Salivary and GCF Biomarkers in Periodontal Health, Gingivitis and Periodontitis
Periodontal Health, Gingivitis
Not yet recruiting
Individualized Management of Plaque-Related Gingival Inflammation in Routine Dental Practice
Plaque-Induced Gingivitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing nitrate-rich lettuce juice and nitrate-depleted lettuce juice in people with Gingivitis, run by Wuerzburg University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gingival Index (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.