The Application of a Fasting- Mimicking Diet in Periodontitis: A Feasibility Study

NCT05684627 | Completed

• 1 other identifier: AkdenizU-1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the present study is to test if a fasting mimicking diet (FMD) can influence the systemic and periodontal response following non-surgical periodontal therapy. The null hypothesis is that a FMD does not modify the local and systemic inflammatory post-treatment response. The test group will have periodontal treatment followed by fasting mimicking diet while the control group will have the same periodontal treatment and continue with their normal diet. Full-mouth clinical periodontal measurements including probing depth (PD), clinical attachment level (CAL), bleeding on probing (BOP), gingival index (GI) and plaque index (PI) will be recorded.Blood and GCF samples will be taken.Enzyme-linked immunosorbent assay (ELISA) will be used to determine biochemical parameters in the biological samples.

Conditions

Periodontitis

Keywords

non surgical treatment; fast-mimicking diet; systemic response; gingival crevicular fluid

Outcome Measures

Primary Outcomes (1)

• Serum CRP level

  Crp level will be evaluated biochemically

  post treatment 90th day

Secondary Outcomes (8)

• Immunological crevicular fluid analysis

  baseline post treatment 1st, 7th and 90th days

• Clinical Attachment Level

  baseline and post treatment 90 days

• Probing Pocket Depth

  baseline and post treatment 90 days

• Bleeding on Probe

  baseline and post treatment 90 days

• Gingival Index

  baseline and post treatment 90 days

Study Arms (2)

Fast mimicking diet group

EXPERIMENTAL

The patients in this group will be assigned to follow one cycle of a fasting mimicking diet (FMD) the same day after receiving the full-mouth non-surgical periodontal treatment.

Dietary Supplement: Fast mimicking diet group

Normal diet group

ACTIVE COMPARATOR

The patients in this group will be assigned to normal diet after receiving the full-mouth non-surgical periodontal treatment.

Procedure: Normal diet group

Interventions

Fast mimicking diet group DIETARY_SUPPLEMENT

Test group will be assigned to follow one cycle of a fasting mimicking diet the same day after receiving the full mouth non surgical periodontal treatment. The FMD program is a plant-based diet program designed to attain fasting-like effects while providing both macro- and micronutrients to minimize the burden of fasting and adverse effects. The FMD consist 5 days regimen that provides approximately 1.100 kilocalories for the first day ; approximately 750 kilocalories per day for the second to the fifth day. FMD group will need 5 visits.

Fast mimicking diet group

Normal diet group PROCEDURE

Normal diet (control) group after receiving the non surgical periodontal treatment (with periodontal Gracey curettes and ultrasonic scaler) will continue with their current diet.Normal diet group will need 5 visits.

Normal diet group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old patients
• Periodontitis stage III-IV, grade B-C
• Systemically healthy
• Normal weight to overweight. Body mass index: 18-30
• Minimum of 24 teeth present
• Be willing and physically able to carry out all study procedures.
• Absence of hopeless teeth, acute dental conditions, teeth with endo-periodontal lesions and necrotising periodontal diseases.

You may not qualify if:

• Age\> 70 years old
• Smokers
• Systemically compromised
• Underweight/Obese
• Pregnant
• Alcoholism
• Systemic antibiotics intake within 3 months
• Periodontal treatment in the last 12 months
• Mental illness, depression, dementia.
• Denture wearer/ presence of dental implants
• Unable or unwilling to participate in baseline or follow up examinations
• Unable or unwilling to complete the dietary intervention
• Significant food allergies

Sponsors & Collaborators

• Akdeniz University: lead

Study Sites (1)

Akdeniz University Faculty of Dentistry

Antalya, 07070, Turkey (Türkiye)

Location

Related Publications (1)

• Mainas G, Ozgu I, Sari A, Vinciguerra M, Ide M, Ayakta BB, Ustun K, Nibali L. The application of a fasting-mimicking diet in periodontitis. A feasibility study. J Dent. 2025 May;156:105644. doi: 10.1016/j.jdent.2025.105644. Epub 2025 Feb 19.

  PMID: 39983975 DERIVED

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Kemal Ustun, Professor

  Head Of Periodontology Department

  STUDY DIRECTOR

• Luigi Nibali, Professor

  Professor and Academic Lead for Periodontology, King's College London, Guy's Hospital

  PRINCIPAL INVESTIGATOR

• Aysegul SARI, Professor

  Mustafa Kemal University

  STUDY CHAIR

• Giuseppe Mainas, Professor

  King's College London, Guy's Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: December 20, 2022
• First Posted: January 13, 2023
• Study Start: March 15, 2023
• Primary Completion: January 15, 2024
• Study Completion: January 15, 2024
• Last Updated: June 12, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)