The Role of Diet in Periodontal Inflammation: A Controlled Clinical Study (NCT05864768) | Clinical Trial Compass
CompletedNot Applicable
The Role of Diet in Periodontal Inflammation: A Controlled Clinical Study
Italy36 participantsStarted 2023-02-16
Plain-language summary
Diet can influence the body's healing and repair mechanisms. A dietary imbalance obviously cannot trigger periodontal disease in the absence of a primum movens, which is bacterial plaque. However, it can condition its severity and extent by altering the permeability of the oral mucosa, the effectiveness of the immune response and the reparative potential of the gingival tissues.
Nutraceuticals is the science that studies the effects of the so-called food-drug, i.e. those foods that contain substances capable of performing a pharmacological function, modifying the functions of the organism. In particular, some molecules that are assimilated through various foods are able to penetrate the cell nucleus and influence, through an epigenetic mechanism, the expression or otherwise of some genes. The aim of the present longitudinal quasi-experimental study was to evaluate the gingival inflammatory response to experimentally induced plaque accumulation in periodontally healthy vegans and omnivores and to explore whether systemic biomarkers mediated the observed clinical effects.
Who can participate
Age range
18 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:
* Optimal systemic health conditions
* Non-Smoking
* Absence of cardio-vascular pathologies
* Absence of pulmonary pathologies
* Non-diabetic
* Not pregnant
* Presence of 28 teeth without prosthetic crowns or subgingival/juxtagingival interproximal restorations
* FMPS \<20% at baseline
* FMBS \<20% at baseline
* Omnivorous or vegan diet for at least a year
* Absence of periodontitis
Exclusion Criteria:
* Smokers
* Presence of systemic pathologies
* Presence of cardio-vascular disease
* Presence of periodontitis
* FMPS\>20% at baseline
* FMBS\>20% at baseline
* Pregnant women
* Presence of blood pathologies
* Taking medicines (hydantoins, nifedipine or cyclosporine)
* Taking oral contraceptives
* Bacterial, viral or fungal infections
* Idiopathic gingival fibromatosis
* Mucocutaneous disorders
* Allergic reactions to toothpastes and mouthwashes
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.