Clinical trial

Application of a Fasting-mimicking Diet in Obese Patients With Periodontitis Stage III-IV

Opening soon · Not applicable · 1 countries · Registry ID NCT07549633

Opening soonNot applicableInterventional

What this study is about

This study will evaluate whether a fasting-mimicking diet (FMD) can improve the systemic and periodontal response to non-surgical periodontal treatment in obese adults with severe periodontitis. Periodontitis is a serious inflammatory disease that damages the tissues supporting the teeth and may also contribute to inflammation elsewhere in the body. Obesity is also associated with increased systemic inflammation, which may worsen periodontal disease and affect treatment outcomes. In this pilot randomized cross-over clinical trial, eligible participants will receive full-mouth non-surgical periodontal therapy and will be assigned either to an FMD group or to a control group continuing their usual diet. The FMD will be administered in three 5-day cycles around the periodontal treatment period. After a wash-out period, the groups will switch interventions. The study will assess whether FMD can reduce systemic inflammation, measured primarily by serum C-reactive protein (CRP), and improve periodontal healing after treatment. Additional outcomes include clinical periodontal measurements, inflammatory markers in gingival crevicular fluid, and changes in oral and gut microbiota. Findings from this study will help determine the feasibility of this dietary approach and provide preliminary data for a larger clinical trial.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 70 Years

SexAll

Healthy volunteersAccepted

ConditionPeriodontitis (Stage 3), Periodontitis Stage IV

Full registry criteria

Inclusion Criteria: * 18-70-year-old patients, * Severe Periodontitis (Stages III-IV), * Systemically healthy, * Overweight (body mass index - BMI \> 30 kg/m2), * Absence of hopeless teeth, acute dental conditions, endo-perio lesions and necrotising periodontal diseases, * Minimum of 20 teeth present. Exclusion Criteria: * Current smokers, * Pregnant women, * Patients drinking more than 20 units of alcohol weekly, * Taking medications including systemic anti-inflammatory medication within 3 months of the study, * Periodontal treatment and/or systemic antibiotics intake within preceding 3 months * Denture wearer/presence of dental implants, * Significant food allergies and/or special dietary requirements which would make the subject unable to consume the food provided.

Treatments and study arms

Fast mimicking diet group

Dietary Supplement

Participants assigned to this intervention will undergo standard non-surgical periodontal therapy and will receive a fasting-mimicking diet (FMD) in three 5-day cycles administered around the treatment period. The FMD is a plant-based, calorie-restricted dietary program composed of foods generally recognized as safe, including vegetable-based soups, energy bars, energy drinks, cracker snacks, olives, herbal teas, and supplements. The regimen provides approximately 1,100 kcal on day 1 and approximately 750 kcal per day on days 2 to 5.

Normal diet group

Procedure

Participants assigned to this intervention will undergo standard non-surgical periodontal therapy and will continue their usual diet without receiving the fasting-mimicking diet during the assigned study phase.

Primary outcomes

Serum CRP valuesat 90- and 360 days post-treatment

CRP level will be evaluated biochemically

Study locations

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Akdeniz University Faculty of Dentistry🌐 Antalya, Turkey (Türkiye)

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İpek Özgü, MSc, Dr.Contact

Email · Call +90 545 525 83 08