Intake of Nitrate-rich Vegetables and Their Effect on Inflammatory Molecules and Oral Microbiota … (NCT05232331) | Clinical Trial Compass
RecruitingNot Applicable
Intake of Nitrate-rich Vegetables and Their Effect on Inflammatory Molecules and Oral Microbiota of Patients With Periodontitis
Mexico60 participantsStarted 2021-06-23
Plain-language 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, which are also bacteria that are associated with oral health.
Who can participate
Age range
30 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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.
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.