The Application of a Fasting- Mimicking Diet in Periodontitis: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Serum CRP level
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Age> 70 years old
- •Systemically compromised
- •Underweight/Obese
- •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
结局指标
主要结局
Serum CRP level
时间窗: post treatment 90th day
Crp level will be evaluated biochemically
次要结局
- Immunological crevicular fluid analysis(baseline post treatment 1st, 7th and 90th days)
- Gingival Index(baseline and post treatment 90 days)
- Clinical Attachment Level(baseline and post treatment 90 days)
- Bleeding on Probe(baseline and post treatment 90 days)
- Serum CRP levels(post treatment 1st, 7th and 90th day)
- Probing Pocket Depth(baseline and post treatment 90 days)
- Plaque Index(baseline and post treatment 90 days)
- Patients reported quality of life measurements(baseline and post treatment 90 days)