The Effect of Twice Daily Kiwifruit Consumption on Periodontal and Systemic Conditions Before and After Treatment: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- Full-mouth bleeding score (FMBS)
研究概览
简要总结
The importance of micronutrients has been extensively reviewed and it was concluded that for prevention and treatment of periodontitis daily nutrition should include sufficient antioxidants, vitamin D and calcium.
Up to now there is limited research available investigating the effect of vitamin C supplementation on the periodontal condition. Supplementation of vitamins and micronutrients has however raised numerous questions on clinical efficacy. Recently, a significant increase of medical literature on the effect of nutraceutical dietary aliments on general health has been noted.
the aim of the present study is twofold. The first objective is to investigate the effect of twice-daily kiwifruit consumption as sole treatment modality in untreated periodontitis, followed after two months by initial periodontal therapy supported by continued kiwifruit consumption. The second objective is to investigate the effect of twice daily kiwifruit consumption on periodontal and systemic parameters of these periodontitis patients 3 months after treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Care Provider, Investigator, 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
- 否
入选标准
- •proximal attachment loss of ≥3 mm in ≥2 non-adjacent teeth,
- •PPD≥4 mm and bleeding on probing on at least 25 % of their total sites
- •documented radiographic bone loss
排除标准
- •younger than 18 years or older than 70 years,
- •pregnant or lactating females,
- •females using contraceptive pharmacological medications,
- •reported diagnosis of any systemic illnesses including cardiovascular, renal, and liver diseases,
- •in need of antibiotic treatment during initial periodontal treatment (IPT),
- •IPT in the previous 6 months,
- •allergic to latex, kiwifruit and fruits in general,
- •suffering of eating or digestive disease or food intolerances,
- •smoking more than 20 cigarettes per day.
研究组 & 干预措施
Test Group
Subjects affected by periodontitis were examined and included in the study. After 2 months subjects also received non-surgical periodontal treatment and then followed for additional 3 months.
Subjects in the test group were instructed to eat two kiwifruit per day during the whole study period.
干预措施: Kiwifruit addition to the diet (Dietary Supplement)
Test Group
Subjects affected by periodontitis were examined and included in the study. After 2 months subjects also received non-surgical periodontal treatment and then followed for additional 3 months.
Subjects in the test group were instructed to eat two kiwifruit per day during the whole study period.
干预措施: Non Surgical periodontal treatment (Procedure)
Control Group
Subjects affected by periodontitis were examined and included in the study. After 2 months subjects also received non-surgical periodontal treatment and then followed for additional 3 months.
Subjects in the control group didi not receive any dietary advice.
干预措施: Non Surgical periodontal treatment (Procedure)
结局指标
主要结局
Full-mouth bleeding score (FMBS)
时间窗: Baseline, 2 months and 3 months after periodontal treatment
Changes of FMBS. Unit of measure %
次要结局
- Systemic inflammation(Baseline, 2 months and 3 months after periodontal treatment)
- Full-mouth plaque score (FMPS)(Baseline, 2 months and 3 months after periodontal treatment)
- Pocket probing depth (PPD)(Baseline, 2 months and 3 months after periodontal treatment)
- Clinical attachment level (CAL)(Baseline, 2 months and 3 months after periodontal treatment)
- Recession of the gingival margin (REC)(Baseline, 2 months and 3 months after periodontal treatment)
- Triglycerides(Baseline, 2 months and 3 months after periodontal treatment)
- Low-density lipoprotein (LDL)(Baseline, 2 months and 3 months after periodontal treatment)
- High-density lipoprotein (HDL)(Baseline, 2 months and 3 months after periodontal treatment)
- Cholesterol(Baseline, 2 months and 3 months after periodontal treatment)
- Glycated Haemoglobin(Baseline, 2 months and 3 months after periodontal treatment)
- Vitamin C(Baseline, 2 months and 3 months after periodontal treatment)
- Systolic Blood Pressure (SBP)(Baseline, 2 months and 3 months after periodontal treatment)
- Diastolic Blood Pressure (DBP)(Baseline, 2 months and 3 months after periodontal treatment)
研究者
Filippo Graziani, DDS MClinDent PhD
Prof. of Periodontology
University of Pisa