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

Primary Purpose

Periodontitis

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Fast mimicking diet group
Normal diet group
Sponsored by
Akdeniz University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis focused on measuring non surgical treatment, fast-mimicking diet, systemic response, gingival crevicular fluid

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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

Sites / Locations

  • Akdeniz University Faculty of DentistryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Fast mimicking diet group

Normal diet group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Serum CRP level
Crp level will be evaluated biochemically

Secondary Outcome Measures

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
Clinical Attachment Level
The probing depth and the distance from the gingival margin to the Cement-Enamel Junction in millimeters.
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.
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.
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.
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.
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).
Serum CRP levels
Crp level will be evaluated biochemically

Full Information

First Posted
December 20, 2022
Last Updated
July 17, 2023
Sponsor
Akdeniz University
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1. Study Identification

Unique Protocol Identification Number
NCT05684627
Brief Title
The Application of a Fasting- Mimicking Diet in Periodontitis: A Feasibility Study
Official Title
The Application of a Fasting- Mimicking Diet in Periodontitis: A Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 15, 2023 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Akdeniz University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis
Keywords
non surgical treatment, fast-mimicking diet, systemic response, gingival crevicular fluid

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fast mimicking diet group
Arm Type
Experimental
Arm Description
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.
Arm Title
Normal diet group
Arm Type
Active Comparator
Arm Description
The patients in this group will be assigned to normal diet after receiving the full-mouth non-surgical periodontal treatment.
Intervention Type
Dietary Supplement
Intervention Name(s)
Fast mimicking diet group
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Normal diet group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Serum CRP level
Description
Crp level will be evaluated biochemically
Time Frame
post treatment 90th day
Secondary Outcome Measure Information:
Title
Immunological crevicular fluid analysis
Description
IL-6, L-1α, IL-1β, IFN-y, VEGF, FGF-β, OPG, MMP-3 and MMP-8 values will be evaluated biochemically
Time Frame
baseline post treatment 1st, 7th and 90th days
Title
Clinical Attachment Level
Description
The probing depth and the distance from the gingival margin to the Cement-Enamel Junction in millimeters.
Time Frame
baseline and post treatment 90 days
Title
Probing Pocket Depth
Description
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.
Time Frame
baseline and post treatment 90 days
Title
Bleeding on Probe
Description
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.
Time Frame
baseline and post treatment 90 days
Title
Gingival Index
Description
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.
Time Frame
baseline and post treatment 90 days
Title
Plaque Index
Description
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.
Time Frame
baseline and post treatment 90 days
Title
Patients reported quality of life measurements
Description
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).
Time Frame
baseline and post treatment 90 days
Title
Serum CRP levels
Description
Crp level will be evaluated biochemically
Time Frame
post treatment 1st, 7th and 90th day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kemal Ustun, Professor
Phone
+90 505 7246991
Email
kemalustun@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ipek Ozgu, Resident
Phone
+90 541 9515000
Email
ipekozgu01@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kemal Ustun, Professor
Organizational Affiliation
Head Of Periodontology Department
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Luigi Nibali, Professor
Organizational Affiliation
Professor and Academic Lead for Periodontology, King's College London, Guy's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Aysegul SARI, Professor
Organizational Affiliation
Mustafa Kemal University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Giuseppe Mainas, Professor
Organizational Affiliation
King's College London, Guy's Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Akdeniz University Faculty of Dentistry
City
Antalya
ZIP/Postal Code
07070
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kemal Ustun, Professor
Phone
+90 505 7246961
Email
kemalustun@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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