Periodontal DiseasesNCT05232331
Intake of Nitrate-rich Vegetables and Their Effect on Inflammatory Molecules and Oral Microbiota of Patients With Periodontitis
A study testing Intake of nitrate rich vegetables in people with Periodontal Diseases and Periodontitis, run by University of Guadalajara at 1 site in Mexico.
Trial summary
Vegetables, mainly green leafy ones and some others like beets, are a rich source of nitrate. Nitrate metabolism has shown benefits to the body and there are recent studies that agree that the consumption of nitrates from vegetables can modify the oral microbiota by increasing species with nitrate-reducing capacity… Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Periodontal Diseases, Periodontitis
- What is being tested?
- Intake of nitrate rich vegetables
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteMexico
- Study dates
- 23 Jun 2021to 31 Dec 2025
- 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and/or women from 30 to 65 years old
- Voluntary participation and signing the written informed consent
- Not receiving nutritional treatment at the time of uptake
- Availability to attend all scheduled visits
- Have an indication to receive nonsurgical periodontal treatment (NSPT)
- Interdental clinical insertion loss ≥3mm and ≥5mm in the buccal or oral area of two or more non-adjacent teeth
- Detectable depths ≥ 5mm in two or more teeth
- Radiographic evidence of periodontal bone loss
Who cannot join
- Trauma-Induced Gingival Recessions
- Cervical caries
- History of bleeding diathesis
- Pregnant or nursing women
- BMI <18.5 kg / m2
- History of any of the following self-reported diseases: type 2 diabetes mellitus, high blood pressure, kidney or liver disease, inflammatory bowel diseases, autoimmune diseases and/ or use of medications to control these diseases.
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- Having or presenting a high risk of infection by tuberculosis, hepatitis B or Human Immunodeficiency Virus (HIV)
- Use of antibiotics (including antibiotic oral rinse) 6 months prior to or during the study
- Having received specialized periodontal treatment in the previous 6 months.
- Smoking habit
- Require an interpreter or not understand Spanish to attend or provide written material.
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Integral Dental Clinics CUCS UDG
Guadalajara, Jalisco, 44340
Alondra Ruiz, PhD, +523312467525, alondracrg80@gmail.com
About this study
Official title: Effect of Nitrate-rich Vegetable Intake on Inflammatory Molecule Levels, Nitrate-reducing Capacity and Oral Microbiota Composition in Patients With Periodontitis
Vegetables, mainly green leafy ones and some others like beets, are a rich source of nitrate. Nitrate metabolism has shown benefits to the body and there are recent studies that agree that the consumption of nitrates from vegetables can modify the oral microbiota by increasing species with nitrate-reducing capacity, which are also bacteria that are associated with oral health.
Read the detailed description
Background. Periodontitis (PD) is a chronic, multifactorial and inflammatory disease caused by the imbalance resulting from the proliferation of certain pathogenic bacteria that alter the symbiotic community and cause oral dysbiosis. Non-surgical periodontal treatment (NSPT) helps to eliminate the pathogenic plaque present and it is of interest to look for adjuvant treatments that contribute to an improvement in oral health, given that, with the passage of time, a recolonization of pathogenic bacteria has been observed, as well as a relapse in patients. The oral microbiota plays a key role in the nitrate reduction process in humans, as certain bacteria reduce exogenous nitrate to nitrite, which is subsequently converted in the body to nitric oxide. Vegetables, mainly green leafy vegetables and some others such as beets, are a rich source of nitrate. Nitrate metabolism has shown benefits for the body and recent studies agree that consumption of nitrates from vegetables can positively modify the oral microbiota. Therefore, we hypothesize that the consumption of vegetables may be an adjuvant in the recovery and improve the condition of patients receiving NSPT and possibly prevent relapse.
Objective. To evaluate the effect of nitrate-rich vegetable intake on salivary levels of inflammatory molecules, nitratoreductive capacity and oral microbiota composition in patients with PD.
Material and methods. A parallel randomized clinical trial (RCT) will be conducted in 60 PD patients who are candidates for NSPT and they will be randomized into two groups. The control group will receive the NSPT and instructions to continue with their usual diet, while the intervention group, in addition to the NSPT, will receive a nutritional intervention to promote the daily consumption of vegetables rich in nitrate. The nutritional intervention will be based on the theory of the wheel of behavior change to achieve the consumption of vegetables rich in nitrate that provide ~ 350 mg of this compound. Both groups will be evaluated before and after the study: clinical, dental, and nutritional parameters. Blood samples will also be taken for blood chemistry and saliva to perform a nitratoreduction test, quantify the amount of nitrates and nitrites and determine the levels of inflammatory molecules, as well as subgingival plaque and tongue scraping, from which DNA will be extracted to be sequenced and to obtain the diversity and abundance of bacteria at the beginning, end of the RCT, 6 months and 12 months later in both groups.
- Conditions
- Periodontal Diseases, Periodontitis
- Being tested
- Intake of nitrate rich vegetables
- Keywords
- Nitrates, Vegetables, Oral Microbiota, Periodontitis, Inflammatory molecules
- Medical subject headings
- Periodontal Diseases, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intake of nitrate rich vegetablesDietary supplement
Nutritional intervention for 10 weeks to increase the consumption of vegetables rich in nitrate. At the beginning of the NSPT on visit 1 (week 2), the first of 5 nutritional interventions will begin with the objective of consuming ~ 350 mg of nitrate daily from vegetables
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | This group will receive non-surgical periodontal treatment, however they will not receive any modification to their diet |
| Intervention | Experimental | This group will receive non-surgical periodontal treatment, and also as a treatment of interest, will receive the indication to consume ~ 350 mg of nitrate from vegetables, as well as an accompaniment to achieve this objective. Receives: Dietary Supplement: Intake of nitrate rich vegetables |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composition of the oral microbiota
The composition of the oral microbiota will be before and after the intervention will be evaluated in both study groups using 16S rRNA gene Illumina sequencing. For their analysis, alpha diversity will be evaluated: richness using the Chao1 index and diversity using the Shannon index; beta diversity with PCoA (principal coordinates analysis). In addition, taxonomic assignment will be performed with the DADA2 protocol at both genus and species (ASVs) level, against the SILVA database.
Measured: 10 weeks, 6 and 12 months
Evaluation of nitrate-reducing capacity
The nitrate-reducing capacity in the mouth will be evaluated before and after the intervention in both study groups. Nitrite and nitrate levels will be quantified in saliva and in a nitrate reduction test. Test strips will be used and measured in a Merck reflectometer, which will provide the mg/L of each metabolite.
Measured: 10 weeks, 6 and 12 months
Dietary intake of nitrate
Three 24-hour diet recall will be performed and the average nitrate intake in g/day will be evaluated. Tables reporting the average amount of nitrate in food will be used and multiplied by the reported amount of food consumed by the participant.
Measured: 10 weeks, 6 and 12 months
Periodontal chart evaluation
Periodontal chart is a tool used by dental professionals to evaluate different parameters such as probing depth, clinical attachment level (CAL), bleeding on probing (BP), plaque or calculus (PoC), which help to identify the condition of the periodontal tissues and determine the status of the disease. The measurement of these parameters may give an indication of the extent and severity of the periodontal disease, a Hu Friedy periodontal probe is used for the evaluation, each tooth is divided into six points for study in the vestibular or lingual and palatal aspect, mesial, central and distal. A periodontist will perform the periodontal chart before and after the intervention in both study groups. The online periodontogram of the Spanish Society of Periodontology and Osseointegration (SEPA) will be used: http://sepa.es/periodontograma/index.html
Measured: 10 weeks, 6 and 12 months
Determination of salivary inflammatory molecules
To obtain the saliva sample, the patient will be provided with a sterile 15 ml tube to deposit the accumulated saliva for 5 minutes, this time will be to obtain the largest possible amount of saliva. The saliva sample will not be stimulated (drooling or salivating). Once 3 ml are obtained, the donation will be finished. The saliva will be handled in a sterile area, 40 µl of metalloproteinase inhibitor will be added for each milliliter of saliva to avoid degradation of the molecules of interest, then it will be centrifuged at 4°C at 3,500 rpm for 10 minutes and, once the centrifugation is finished, 250 µl will be aliquoted in 1.5 ml microtubes (a total of 4 tubes) for the determination of the molecules with ELISA kit.
Measured: 10 weeks, 6 and 12 months
Secondary outcomes (4)
Probing depth (PD)
The periodontal probe is inserted along the root surface of the tooth in order to measure the distance from gingival margin to pocket bottom of the periodontal pocket. The values are measured in mm, six sites per tooth, measurements are expressed as averages.
Measured: 10 weeks
Clinical attachment level (CAL)
The clinical attachment level provides an estimation of the true periodontal support and is used for monitoring changes in periodontal support over the time.
The "Attachment Level" for each site will be calculated based on the following formula: probing depth (mm) less gingival margin (mm) if the cemento-enamel junction (CEJ) is cover to the gingival margin. In situation where the gingival margin is apical to the CEJ, probing depth (mm) sum the distance to CEJ at gingival margin (mm). The values are measured in mm, six sites per tooth for each teeth present in the mouth, measurements are expressed as averages.
Measured: 10 weeks
Bleeding on probing (BP)
The periodontal probe is carefully introduced to the bottom of the pocket and gently moved laterally around the tooth, six points are recorded for each tooth as bleeding present or absent, the measurements are expressed as percentage of bleeding on probing of teeth present in the mouth.
The bleeding in each tooth is identified and the values obtained are used to average the bleeding.
Measured: 10 weeks
Plaque or calculus (PoC)
The presence of plaque and calculus is evaluated and marked as present or absent on the periodontal chart based on 6 points on the tooth, the measurements are expressed as percentage of plaque or calculus (PoC).
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2022
- Study start23 Jun 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies 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
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Guadalajara
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lucrecia Carrera, PhD, Principal investigator, University of Guadalajara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05232331
- Sponsor's protocol ID
- CI-02721
- Status last verified
- Aug 2024
- First submitted
- 26 Nov 2021
- Last updated
- 16 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nitrate-rich Vegetable Intake on Inflammatory Molecule Levels, Nitrate-reducing Capacity and Oral Microbiota Composition in Patients With Periodontitis
- ClinicalTrials.gov ID
- NCT05232331
- Acronym / sponsor ID
- CI-02721
- Conditions
- Periodontal Diseases, Periodontitis
- Keywords
- Nitrates, Vegetables, Oral Microbiota, Periodontitis, Inflammatory molecules
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of GuadalajaraUniversity, hospital or other
- Study start
- 23 Jun 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 9 Feb 2022 (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.
Vegetables, mainly green leafy ones and some others like beets, are a rich source of nitrate. Nitrate metabolism has shown benefits to the body and there are recent studies that agree that the consumption of nitrates from vegetables can modify the oral microbiota by increasing species with nitrate-reducing capacity, which are also bacteria that are associated with oral health.
Detailed description
Background. Periodontitis (PD) is a chronic, multifactorial and inflammatory disease caused by the imbalance resulting from the proliferation of certain pathogenic bacteria that alter the symbiotic community and cause oral dysbiosis. Non-surgical periodontal treatment (NSPT) helps to eliminate the pathogenic plaque present and it is of interest to look for adjuvant treatments that contribute to an improvement in oral health, given that, with the passage of time, a recolonization of pathogenic bacteria has been observed, as well as a relapse in patients. The oral microbiota plays a key role in the nitrate reduction process in humans, as certain bacteria reduce exogenous nitrate to nitrite, which is subsequently converted in the body to nitric oxide. Vegetables, mainly green leafy vegetables and some others such as beets, are a rich source of nitrate. Nitrate metabolism has shown benefits for the body and recent studies agree that consumption of nitrates from vegetables can positively modify the oral microbiota. Therefore, we hypothesize that the consumption of vegetables may be an adjuvant in the recovery and improve the condition of patients receiving NSPT and possibly prevent relapse.
Objective. To evaluate the effect of nitrate-rich vegetable intake on salivary levels of inflammatory molecules, nitratoreductive capacity and oral microbiota composition in patients with PD.
Material and methods. A parallel randomized clinical trial (RCT) will be conducted in 60 PD patients who are candidates for NSPT and they will be randomized into two groups. The control group will receive the NSPT and instructions to continue with their usual diet, while the intervention group, in addition to the NSPT, will receive a nutritional intervention to promote the daily consumption of vegetables rich in nitrate. The nutritional intervention will be based on the theory of the wheel of behavior change to achieve the consumption of vegetables rich in nitrate that provide ~ 350 mg of this compound. Both groups will be evaluated before and after the study: clinical, dental, and nutritional parameters. Blood samples will also be taken for blood chemistry and saliva to perform a nitratoreduction test, quantify the amount of nitrates and nitrites and determine the levels of inflammatory molecules, as well as subgingival plaque and tongue scraping, from which DNA will be extracted to be sequenced and to obtain the diversity and abundance of bacteria at the beginning, end of the RCT, 6 months and 12 months later in both groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –This group will receive non-surgical periodontal treatment, however they will not receive any modification to their diet |
| Intervention | Experimental | Dietary Supplement: Intake of nitrate rich vegetablesThis group will receive non-surgical periodontal treatment, and also as a treatment of interest, will receive the indication to consume ~ 350 mg of nitrate from vegetables, as well as an accompaniment to achieve this objective. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Men and/or women from 30 to 65 years old
- Voluntary participation and signing the written informed consent
- Not receiving nutritional treatment at the time of uptake
- Availability to attend all scheduled visits
- Have an indication to receive nonsurgical periodontal treatment (NSPT)
Key exclusion criteria (11 listed)
- Trauma-Induced Gingival Recessions
- Cervical caries
- History of bleeding diathesis
- Pregnant or nursing women
- BMI <18.5 kg / m2
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 |
|---|---|---|
| Intake of nitrate rich vegetablesNutritional intervention for 10 weeks to increase the consumption of vegetables rich in nitrate. At the beginning of the NSPT on visit 1 (week 2), the first of 5 nutritional interventions will begin with the objective of consuming ~ 350 mg of nitrate daily from vegetables | Dietary supplement | Intervention |
Primary outcome
Composition of the oral microbiota
Time frame: 10 weeks, 6 and 12 months
The composition of the oral microbiota will be before and after the intervention will be evaluated in both study groups using 16S rRNA gene Illumina sequencing. For their analysis, alpha diversity will be evaluated: richness using the Chao1 index and diversity using the Shannon index; beta diversity with PCoA (principal coordinates analysis). In addition, taxonomic assignment will be performed with the DADA2 protocol at both genus and species (ASVs) level, against the SILVA database.
Evaluation of nitrate-reducing capacity
Time frame: 10 weeks, 6 and 12 months
The nitrate-reducing capacity in the mouth will be evaluated before and after the intervention in both study groups. Nitrite and nitrate levels will be quantified in saliva and in a nitrate reduction test. Test strips will be used and measured in a Merck reflectometer, which will provide the mg/L of each metabolite.
Dietary intake of nitrate
Time frame: 10 weeks, 6 and 12 months
Three 24-hour diet recall will be performed and the average nitrate intake in g/day will be evaluated. Tables reporting the average amount of nitrate in food will be used and multiplied by the reported amount of food consumed by the participant.
Periodontal chart evaluation
Time frame: 10 weeks, 6 and 12 months
Periodontal chart is a tool used by dental professionals to evaluate different parameters such as probing depth, clinical attachment level (CAL), bleeding on probing (BP), plaque or calculus (PoC), which help to identify the condition of the periodontal tissues and determine the status of the disease. The measurement of these parameters may give an indication of the extent and severity of the periodontal disease, a Hu Friedy periodontal probe is used for the evaluation, each tooth is divided into six points for study in the vestibular or lingual and palatal aspect, mesial, central and distal. A periodontist will perform the periodontal chart before and after the intervention in both study groups. The online periodontogram of the Spanish Society of Periodontology and Osseointegration (SEPA) will be used: http://sepa.es/periodontograma/index.html
Determination of salivary inflammatory molecules
Time frame: 10 weeks, 6 and 12 months
To obtain the saliva sample, the patient will be provided with a sterile 15 ml tube to deposit the accumulated saliva for 5 minutes, this time will be to obtain the largest possible amount of saliva. The saliva sample will not be stimulated (drooling or salivating). Once 3 ml are obtained, the donation will be finished. The saliva will be handled in a sterile area, 40 µl of metalloproteinase inhibitor will be added for each milliliter of saliva to avoid degradation of the molecules of interest, then it will be centrifuged at 4°C at 3,500 rpm for 10 minutes and, once the centrifugation is finished, 250 µl will be aliquoted in 1.5 ml microtubes (a total of 4 tubes) for the determination of the molecules with ELISA kit.
4 secondary outcomes
Probing depth (PD)
Time frame: 10 weeks
Clinical attachment level (CAL)
Time frame: 10 weeks
Bleeding on probing (BP)
Time frame: 10 weeks
Plaque or calculus (PoC)
Time frame: 10 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
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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.
Lucrecia Carrera, PhD principal investigator
University of Guadalajara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intake of nitrate rich vegetables in people with Periodontal Diseases and Periodontitis, run by University of Guadalajara at 1 site in Mexico.
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 8 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 16 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lucrecia Carrera, PhD (+523310585200 ext. 34240, lucrecia.carrera@academicos.udg.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composition of the oral microbiota (time frame: 10 weeks, 6 and 12 months). The study lists 5 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 16 Aug 2024.