Experimental Gingivitis in Omnivores and Vegans. The Role of Diet in Periodontal Inflammation: A Controlled Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Eastman Interdental Bleeding Index
研究概览
简要总结
Diet can influence the body's healing and repair mechanisms. A dietary imbalance obviously cannot trigger periodontal disease in the absence of a primum movens, which is bacterial plaque. However, it can condition its severity and extent by altering the permeability of the oral mucosa, the effectiveness of the immune response and the reparative potential of the gingival tissues.
Nutraceuticals is the science that studies the effects of the so-called food-drug, i.e. those foods that contain substances capable of performing a pharmacological function, modifying the functions of the organism. In particular, some molecules that are assimilated through various foods are able to penetrate the cell nucleus and influence, through an epigenetic mechanism, the expression or otherwise of some genes. The aim of the present longitudinal quasi-experimental study was to evaluate the gingival inflammatory response to experimentally induced plaque accumulation in periodontally healthy vegans and omnivores and to explore whether systemic biomarkers mediated the observed clinical effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Optimal systemic health conditions
- •Non-Smoking
- •Absence of cardio-vascular pathologies
- •Absence of pulmonary pathologies
- •Non-diabetic
- •Not pregnant
- •Presence of 28 teeth without prosthetic crowns or subgingival/juxtagingival interproximal restorations
- •FMPS <20% at baseline
- •FMBS <20% at baseline
- •Omnivorous or vegan diet for at least a year
- •Absence of periodontitis
排除标准
- •Presence of systemic pathologies
- •Presence of cardio-vascular disease
- •Presence of periodontitis
- •FMPS>20% at baseline
- •FMBS>20% at baseline
- •Pregnant women
- •Presence of blood pathologies
- •Taking medicines (hydantoins, nifedipine or cyclosporine)
- •Taking oral contraceptives
- •Bacterial, viral or fungal infections
- •Idiopathic gingival fibromatosis
- •Mucocutaneous disorders
- •Allergic reactions to toothpastes and mouthwashes
研究组 & 干预措施
Patients with an omnivorous diet
After excluding patients with clinical signs of periodontitis, the patients recruited at baseline underwent prophylaxis and home oral hygiene instructions were given with brushing and flossing in order to reduce the parameters of inflammation and the presence of plaque (FMPS and FMBS).
After patient recruitment and prior to baseline assessment, fasting venous blood samples will be collected to evaluate metabolic, inflammatory, oxidative stress, and hematological parameters, including fasting glucose, lipid profile, CRP, d-ROMs, BAP, and complete blood count. The Systemic Immune-Inflammation Index (SII) will be calculated.
After 15 days from baseline (T0) all patients were recorded the parameters of FMPS, FMBS and Eastman Interdental Bleeding Index (EIBI) and were asked to stop using dental floss and mouthwash. All patients were recalled weekly 4 times after T0 (T1, T2, T3, T4) in order to monitor the parameters of inflammation and plaque accumulation by recording FMBS, FMPS and EIBI.
干预措施: Omnivorous diet (Dietary Supplement)
结局指标
主要结局
Eastman Interdental Bleeding Index
时间窗: Four weeks
A wooden wedge is inserted buccally into the interdental space 1-2 mm, perpendicular to the long axis of the tooth, to assess for the presence of interdental inflammation (Yes/No).
次要结局
- Full Mouth Plaque Score(Four weeks)
- Pocket Probing Depth(Four weeks)
- Full Mouth Bleeding Score(Four weeks)
研究者
Michele Paolantonio
Full Time Professor
G. d'Annunzio University