Effect of Propolis Extract, Nanovitamin C and Nanovitamin E in Clinical and Microbiological Parameters of Peri-implant Mucositis: A Double-blind, Randomized, Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Changes in bleeding on probing
研究概览
简要总结
The objective of this study was to perform the first clinical trial to evaluate the effectiveness of propolis extract, nanovitamin C and nanovitamin E gel as adjuvant to mechanical debridement in clinical and microbiological parameters of implants with peri-implant mucositis
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •cooperative adult patients,
- •with one or more implants with peri-implant mucositis, and
- •presenting at least 18 months of functional loading.
排除标准
- •refuse to participate in the study,
- •patients who had implants with peri-implantitis (BOP and/or suppuration together with progressive radiographic marginal bone loss),
- •patients with uncontrolled periodontitis (presence of nine or more sites with PD ≥ 5 mm and with full-mouth bleeding score (FMBS) > 25%),
- •systemic diseases or conditions that could alter the results of the study (diabetes mellitus, immunosuppression, infectious diseases, rheumatoid disease, history of bisphosphonate treatment, radiotherapy, chemotherapy, etc.),
- •patients who had taken local and/or systemic antibiotics less than 2 months ago,
- •pregnant or breastfeeding women, and
- •patients with history of allergies to the test and/or placebo components administered.
研究组 & 干预措施
Test group
Gel contained in tubes with the same appearance (30g), identical in colour, flavour and density, with the following components: Sodium-Monofluorophosphate, Silicon Dioxide, Glycerin, D-sorbitol, Polyethylene glycol, Sodium Carboxymethylcellulose, Xylitol, Sterol Glycoside, Peppermint Oil, L-Menthol, Methyl Hydroxybenzoate, Deionized Water, Propolis Extract (2%), Ascorbic Acid (0.2%) and Tocopherol Acetate (0.2%).
干预措施: Gel containing propolis extract, nanovitamin C and nanovitamin E (Device)
Placebo group
Gel contained in tubes with the same appearance (30g), identical in colour, flavour and density, with the following components: Sodium-Monofluorophosphate, Silicon Dioxide, Glycerin, D-sorbitol, Polyethylene glycol, Sodium Carboxymethylcellulose, Xylitol, Sterol Glycoside, Peppermint Oil, L-Menthol, Methyl Hydroxybenzoate, Deionized Water and E155/151 coloring.
干预措施: Placebo (Device)
结局指标
主要结局
Changes in bleeding on probing
时间窗: baseline and 1-month follow-up
It was present when it appeared bleeding at the gingival margin after recording probing depths at six sites in each implant. Modified bleeding index was also collected.
次要结局
- Changes in probing depth(baseline and 1-month follow-up)
- Changes in microbilogical sample(baseline and 1-month follow-up)
- Changes in plaque index(baseline and 1-month follow-up)
研究者
Rosa María López-Pintor Muñoz
Associate professor
Universidad Complutense de Madrid