Diet that mimics fasting to treat gum disease
The Effect of a Fast-mimicking Diet on Periodontal Clinical and Systemic Response to Non-surgical Treatment of Stage III-IV Periodontitis: a Multi-centre Randomised Controlled Trial With Internal Pilot
This study is testing if a special diet that mimics fasting can help people with advanced gum disease feel better and improve their overall health when combined with regular gum treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Universitat Internacional de Catalunya Academic / other |
| Locations | 5 sites (Sant Cugat Del Vallès, Barcelona and 4 other locations) |
| Trial ID | NCT06074861 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of a fasting-mimicking diet combined with non-surgical periodontal therapy on patients with advanced periodontitis. The study aims to determine whether this dietary approach can reduce inflammation and improve oral and systemic health following periodontal treatment. Conducted across five centers in Spain, the trial will assess participants' responses to the diet and its potential benefits on gum disease outcomes. Participants will undergo multiple cycles of a 5-day dietary regimen while receiving standard periodontal care.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 with stages III-IV generalized periodontitis and a body mass index between 18.5-30.
Not a fit: Patients over 70 years old or those with acute dental conditions or hopeless teeth may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved treatment outcomes for patients with advanced gum disease by reducing inflammation and enhancing recovery.
How similar studies have performed: While there is emerging evidence on dietary interventions in periodontal health, this specific fasting-mimicking approach is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18-70 years * Periodontitis stages III-IV, generalized, grade C-B (according to the New World Workshop 2017) * Minimum of 20 teeth present: to ensure there are sufficient teeth for study and that the same teeth can be examined in all participants. * Systemically healthy participants (self-reported questionnaires will be used). * Body mass index: 18.5-30 kg/m2 (normal weight to overweight, but not obese) * Be willing and competent (verbally and cognitively) to give written informed consent and complete a medical history form * Be willing and physically able to carry out all study procedures (e.g. multiple cycles of a 5-day dietary regimen and blood samples) * Absence of hopeless teeth, acute dental conditions, teeth with endodontic-periodontal lesions and necrotising periodontal diseases Exclusion Criteria: * Age \> 70 years. Exclusion for safety and feasibility reasons and to minimize the complicating factors such as frailty and un-/under-diagnosed medical conditions. * Less than 20 teeth present * Patients who received any periodontal treatment in the last 12 months * Smoking (defined as self-reported use of any cigarettes or electronic cigarettes for at least 5 years): to avoid the potential confounding effect of smoking * Mental illness, including severe depression, dementia. To ensure safety and compliance of the protocol * Drug dependency * Hormone replacement therapy (DHEA, estrogen, thyroid, testosterone). * Severe hypertension (systolic BP \> 200 mm Hg and/or diastolic BP \> 105 mm Hg) * Underweight (BMI \< 18.5 kg/m2) * Currently taking part in other clinical trials: to prevent either from interfering with the results of the other * Pregnant or breastfeeding women: to prevent hormonal changes from influencing the amount of inflammation * Taking medications including systemic anti-inflammatory medication within 3 months of the study (NSAIDs, no more than once per week and not in the week before sample collection, is permitted) * Systemic antibiotic intake within 3 months: to prevent their microbiome-modulating effects from impacting the inflammatory status. * Current orthodontic treatment: interferes with plaque control measures. * Alcoholism (alcohol intake greater than two drinks per day for women and three drinks per day for men) * Denture wearer/presence of dental implants: They may have an effect on periodontal parameters of neighbouring teeth * Obvious signs of untreated caries and other significant oral diseases which in the opinion of the Study Dentist will affect either the scientific validity of the study, or if the volunteer was to participate in the study would affect their wellbeing * Unable or unwilling to participate in baseline or follow-up examinations * Unable or unwilling to complete the dietary intervention * Special dietary requirements incompatible with the study interventions * Significant food allergies which would make the subject unable to consume the food provided
Where this trial is running
Sant Cugat Del Vallès, Barcelona and 4 other locations
- Universitat Internacional de Catalunya — Sant Cugat Del Vallès, Barcelona, Spain (Recruiting)
- Universidad de Granada — Granada, Spain (Recruiting)
- Universidad Complutense de Madrid — Madrid, Spain (Recruiting)
- Universidad de Murcia — Murcia, Spain (Recruiting)
- Universida de Santiago de Compostela — Santiago De Compostela, Spain (Recruiting)
Study contacts
- Principal investigator: Luigi Nibali, DDS, PhD — King's College London
- Study coordinator: Giuseppe Mainas, DDS, PhDc
- Email: gmainas@uic.es
- Phone: 00393345921869
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.