PeriodontitisNCT05684627
The Application of a Fasting- Mimicking Diet in Periodontitis: A Feasibility Study
A study testing Fast mimicking diet group and Normal diet group in people with Periodontitis, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- Fast mimicking diet group and Normal diet group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2023to 15 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-70 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.
Who cannot join
- Age> 70 years old
- Smokers
- Systemically compromised
- Underweight/Obese
- Pregnant
- Alcoholism
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Akdeniz University Faculty of Dentistry
Antalya, 07070
About this study
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.
Read the detailed description
This is a multi-center randomized controlled trial with internal pilot.The study protocol was approved by the Ethics Committee for the Use of Human Subjects in Research of Hatay Mustafa Kemal University. Participants will be selected from the patients who consult to the Periodontology Clinic of Akdeniz University Faculty of Dentistry. (Antalya, TURKEY).Participants will be screened by clinical staff/ investigator. We expect 20 eligible participants available per year.
The FMD program is a plant-based diet program and consists of a 5-days regimen. Test 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 (NSPT). In contrast, control group after receiving the NSPT will continue with their current diet.
Patients in the test group will need 5 visits and patients in the control group will also need 5 visits.
At the screening visit, consent will be sought by the trained applicant which will be recorded through a written participant consent form detailing the complete trial procedure and an agreement checklist for each data collection method.
Visit 1 (Day -7/-10): Informed consent will be given and signed, blood and GCF samples will be collected, medical history will be checked and oral examination will be carried out including recording number of teeth and at 6 sites per tooth probing depth,recession (mm) and bleeding after probing.A very superficial prophylaxis , motivation and oral hygiene instructions will be provided.
On day 0 Morning (Visit 2) : Patients will undergo full-mouth subgingival instrumentation procedures and more detailed hygiene instruction will be reinforced. In the afternoon patients of the test group will start the FMD for 5 consecutive days.
On day 1(Visit 3) :Blood and GCF samples will be taken. Medical history, adverse events and concomitant medications will be checked.
On day 7 (Visit 4 ): Blood and GCF samples will be taken. Medical history, adverse events and concomitant medications will be checked.
On day 90±5 (visit 5): Full mouth periodontal charting measurements will be recorded. Blood and GCF sample swill be taken. Periodontal re-evaluation will be done.
The samples will be collected during the study visit from the patient by investigator, who will participate in this study. GCF Periopaper Strips will be used in the gingival crevice of the teeth. They will then be immediately measured on a calibrated Periotron 8000 electronic transducer. Once measured gcf strips for that visit will all be stored in a single 2 ml tube and pooled for further analysis.
4 ml of venous blood will be collected from the participant's arm into hemogard sterile vacutainers. The samples for serum will be centrifuged for 5 mins at 40,000 rpm then immediately divided into 1 ml aliquots and stored in a freezer at - 80°C, until required for analysis. After their initial storage, the sample will be transferred to the Microbiome and Salivary laboratories of Guy's Hospital.
Blood samples will be tested for cytokines, acute phase proteins and inflammtory markers. Gingival Crevicular Fluid will be analyzed for inflammatory mediators, antibodies, peptides and cytokines using techniques such as ELISA.
Circulating levels of IGF-1, fasting blood glucose level will be assessed to monitor the compliance of FMD.
- Conditions
- Periodontitis
- Being tested
- Fast mimicking diet group, Normal diet group
- Keywords
- non surgical treatment, fast-mimicking diet, systemic response, gingival crevicular fluid
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fast mimicking diet groupDietary 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.
Normal diet groupProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Normal diet group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum CRP level
Crp level will be evaluated biochemically
Measured: post treatment 90th day
Secondary outcomes (8)
Immunological crevicular fluid analysis
IL-6, L-1α, IL-1β, IFN-y, VEGF, FGF-β, OPG, MMP-3 and MMP-8 values will be evaluated biochemically
Measured: baseline post treatment 1st, 7th and 90th days
Clinical Attachment Level
The probing depth and the distance from the gingival margin to the Cement-Enamel Junction in millimeters.
Measured: baseline and post treatment 90 days
Probing Pocket Depth
The distance from the gingival margin to the apical portion of the gingival sulcus in millimeters. Probing depths in healthy gingival sulcus normally range from 1 to 3 mm.
Measured: baseline and post treatment 90 days
Bleeding on Probe
To accurately determine the patient's periodontal health, the dental professional will record the sulcular depths of the gingiva. Any bleeding which occurs upon probing will also be recorded. A periodontal probe is used for this test.The number of sites which bleed are used to calculate the gingival bleeding score.
Measured: baseline and post treatment 90 days
Gingival Index
The bleeding is assessed by probing gently along the wall of soft tissue of the gingival sulcus.The GI of the individual can be obtained by adding the values of each tooth and dividing by the number of teeth examined.The probed values are scored between 0-3.
Score 0 = Normal gingiva.
Score 1 = Mild inflammation - slight change in color, slight edema. No bleeding on probing.
Score 2 = Moderate inflammation - redness, edema, glazing. Bleeding on probing.
Score 3 = Severe inflammation - marked redness and edema, ulceration. Tendency toward spontaneous bleeding.
The GI may be used for the assessment of prevalence and severity of gingivitis in populations, groups and individuals.A score from 0.1-1.0 = mild inflammation; 1.1-2.0 = moderate inflammation from, and 2.1-3.0 signifies severe inflammation.
Measured: baseline and post treatment 90 days
Plaque Index
The measurement of the state of oral hygiene by Silness-Löe plaque index is based on recording both soft debris and mineralized deposits on the following teeth: Missing teeth are not substituted. Each of the four surfaces of the teeth (buccal, lingual, mesial and distal) is given a score from 0-3.
0= No plaque
1= A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may be seen in situ only after application of disclosing solution or by using the probe on the tooth surface.
2 =Moderate accumulation of soft deposits within the gingival pocket, or the tooth and gingival margin which can be seen with the naked eye.
3 =Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.
Measured: baseline and post treatment 90 days
Patients reported quality of life measurements
Patients' outcomes will be assessed by Oral Health Impact Profile-14 (OHIP-14) questionnaire which is used to evaluate the impact oral health (including functional limitations, pain, physiological discomfort, physical disability, social disability, sense of taste, diet unsatisfactory and handicap) on person's life.
The Oral Health Impact Profile-14 (OHIP-14) was designed to assess patients' perception of the impact of oral disorders on their quality of life (QoL).
Measured: baseline and post treatment 90 days
Serum CRP levels
Crp level will be evaluated biochemically
Measured: post treatment 1st, 7th and 90th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start15 Mar 2023
- Primary completion15 Jan 2024
- Study completion15 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by Akdeniz UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İpek Özgü, Akdeniz University
- Investigators
- Kemal Ustun, Professor, Study director, Head Of Periodontology DepartmentLuigi Nibali, Professor, Principal investigator, Professor and Academic Lead for Periodontology, King's College London, Guy's HospitalAysegul SARI, Professor, Study chair, Mustafa Kemal UniversityGiuseppe Mainas, Professor, Study director, King's College London, Guy's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05684627
- Sponsor's protocol ID
- AkdenizU-1
- Status last verified
- Jun 2024
- First submitted
- 20 Dec 2022
- Last updated
- 12 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39983975
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of a Fasting- Mimicking Diet in Periodontitis: A Feasibility Study
- ClinicalTrials.gov ID
- NCT05684627
- Acronym / sponsor ID
- AkdenizU-1
- Conditions
- Periodontitis
- Keywords
- non surgical treatment, fast-mimicking diet, systemic response, gingival crevicular fluid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 15 Jan 2024 (actual)
- Study completion
- 15 Jan 2024 (actual)
- First posted
- 13 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a multi-center randomized controlled trial with internal pilot.The study protocol was approved by the Ethics Committee for the Use of Human Subjects in Research of Hatay Mustafa Kemal University. Participants will be selected from the patients who consult to the Periodontology Clinic of Akdeniz University Faculty of Dentistry. (Antalya, TURKEY).Participants will be screened by clinical staff/ investigator. We expect 20 eligible participants available per year.
The FMD program is a plant-based diet program and consists of a 5-days regimen. Test 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 (NSPT). In contrast, control group after receiving the NSPT will continue with their current diet.
Patients in the test group will need 5 visits and patients in the control group will also need 5 visits.
At the screening visit, consent will be sought by the trained applicant which will be recorded through a written participant consent form detailing the complete trial procedure and an agreement checklist for each data collection method.
Visit 1 (Day -7/-10): Informed consent will be given and signed, blood and GCF samples will be collected, medical history will be checked and oral examination will be carried out including recording number of teeth and at 6 sites per tooth probing depth,recession (mm) and bleeding after probing.A very superficial prophylaxis , motivation and oral hygiene instructions will be provided.
On day 0 Morning (Visit 2) : Patients will undergo full-mouth subgingival instrumentation procedures and more detailed hygiene instruction will be reinforced. In the afternoon patients of the test group will start the FMD for 5 consecutive days.
On day 1(Visit 3) :Blood and GCF samples will be taken. Medical history, adverse events and concomitant medications will be checked.
On day 7 (Visit 4 ): Blood and GCF samples will be taken. Medical history, adverse events and concomitant medications will be checked.
On day 90±5 (visit 5): Full mouth periodontal charting measurements will be recorded. Blood and GCF sample swill be taken. Periodontal re-evaluation will be done.
The samples will be collected during the study visit from the patient by investigator, who will participate in this study. GCF Periopaper Strips will be used in the gingival crevice of the teeth. They will then be immediately measured on a calibrated Periotron 8000 electronic transducer. Once measured gcf strips for that visit will all be stored in a single 2 ml tube and pooled for further analysis.
4 ml of venous blood will be collected from the participant's arm into hemogard sterile vacutainers. The samples for serum will be centrifuged for 5 mins at 40,000 rpm then immediately divided into 1 ml aliquots and stored in a freezer at - 80°C, until required for analysis. After their initial storage, the sample will be transferred to the Microbiome and Salivary laboratories of Guy's Hospital.
Blood samples will be tested for cytokines, acute phase proteins and inflammtory markers. Gingival Crevicular Fluid will be analyzed for inflammatory mediators, antibodies, peptides and cytokines using techniques such as ELISA.
Circulating levels of IGF-1, fasting blood glucose level will be assessed to monitor the compliance of FMD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fast mimicking diet group | Experimental | Dietary Supplement: Fast mimicking diet groupThe 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. |
| Normal diet group | Active comparator | Procedure: Normal diet groupThe patients in this group will be assigned to normal diet after receiving the full-mouth non-surgical periodontal treatment. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18-70 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
Key exclusion criteria (13 listed)
- Age> 70 years old
- Smokers
- Systemically compromised
- Underweight/Obese
- Pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fast mimicking diet groupTest 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. | Dietary supplement | Fast mimicking diet group |
| Normal diet groupNormal 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. | Procedure or surgery | Normal diet group |
Primary outcome
Serum CRP level
Time frame: post treatment 90th day
Crp level will be evaluated biochemically
8 secondary outcomes
Immunological crevicular fluid analysis
Time frame: baseline post treatment 1st, 7th and 90th days
Clinical Attachment Level
Time frame: baseline and post treatment 90 days
Probing Pocket Depth
Time frame: baseline and post treatment 90 days
Bleeding on Probe
Time frame: baseline and post treatment 90 days
Gingival Index
Time frame: baseline and post treatment 90 days
Plaque Index
Time frame: baseline and post treatment 90 days
Patients reported quality of life measurements
Time frame: baseline and post treatment 90 days
Serum CRP levels
Time frame: post treatment 1st, 7th and 90th day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
- Derived from this study: PubMed 39983975Mainas 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.
- Individual participant dataSharing planned: No
Related trials for Periodontitis
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
Active, not recruitingObservational study
A Retrospective Comparative Evaluation of Omega-3 and Resveratrol Supplementation in Patients With Periodontitis
Periodontitis
Recruiting
Probiotics Versus Antibiotics as an Adjuvant to Non-surgical Periodontal Treatment Among Smokers With Stage II, Grade B Periodontitis
Probiotics, Antibiotics
Recruiting
Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Apical Periodontitis, Endodontic Retreatment
Recruiting
Ozone Gel Versus Chlorohexidine Gel as an Adjunct to Non-Surgical Treatment of Stage II Periodontitis Grade B Among Smokers Patients
Ozone Gel, Chlorohexidine Gel
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kemal Ustun, Professor study director
Head Of Periodontology Department
Luigi Nibali, Professor principal investigator
Professor and Academic Lead for Periodontology, King's College London, Guy's Hospital
Aysegul SARI, Professor study chair
Mustafa Kemal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fast mimicking diet group and Normal diet group in people with Periodontitis, run by Akdeniz University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum CRP level (time frame: post treatment 90th day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05684627, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2024.