Ozone Therapy as an Aid for Home Oral Hygiene. The Use of Aquolab in the Pregnant Woman.
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Periodontal Screening Recording (PSR)
研究概览
简要总结
The aim of the present study is analyzing the effect of an domestic ozonated water delivering device on the oral health status of pregnant women.
Two groups of 30 women will be enrolled following a simple randomization scheme: the group A will be equipped with a domestic ozonated water delivering device and a control group B that will not be equipped with the device. The sample size was calculated with a power analysis performed starting from descriptive data differences obtained from a pilot study in order to achieve a power higher than 80 percent with an alpha error of 0.05 resulting in a minimum of 27 participants for each group.
The protocol was in accordance with the Declaration of Helsinki and was approved by the Ethical Committee of the IRCCS San Raffaele Hospital, all the participants will be informed about the aim of the study and will sign an informed consent form.
At the first examination (T0) the clinical oral hygiene parameters will be recorded on the enrolled participants of both the groups and they will be subjected to a professional oral hygiene procedure with appropriate home oral hygiene instructions. The same clinical oral hygiene parameters will be recorded also after 15 days (T1) and after 75 days (T2) from the first examination.
All the clinical procedures and data recording will be conducted by the operator X blind to the participants group while the operator Y will give the device and instruct the participants to its proper use.
After a descriptive analysis of the data, an analysis of the data distribution will be performed with the Kolmogorov-Smirnov test. According with the result of the data distribution analysis the differences between-groups and within-groups will be evaluated with the proper parametric or non-parametric test.
详细描述
The aim of the present study is analyzing the effect of an domestic ozonated water delivering device on the oral health status of pregnant women.
In the present study a total of 60 pregnant women will be recruited at the dental clinic of the IRCCS San Raffaele Hospital. These participants must adhere to the following inclusion criteria: legal age, pregnancy period between the 14 and 30 week, diagnosis positive for pregnancy gingivitis, presence of at least 20 teeth. The following exclusion criteria will be applied: absumption of alcohol during pregnancy, systemic diseases, chronic drug assumption, allergies, ongoing orthodontic therapies, positive periodontal screening recording (PSR).
The participants will be assigned to two groups following a simple randomization scheme: the group A will be equipped with a domestic ozonated water delivering device (Aquolab®, EB2C, Milan, Italy) and a control group B that will not be equipped with the device. The sample size was calculated with a power analysis performed starting from descriptive data differences obtained from a pilot study in order to achieve a power higher than 80 percent with an alpha error of 0.05 resulting in a minimum of 27 participants for each group. A total of 30 subjects will be assigned to each group in order to prevent possible drop-outs.
The protocol was in accordance with the Declaration of Helsinki and was approved by the Ethical Committee of the IRCCS San Raffaele Hospital, all the participants will be informed about the aim of the study and will sign an informed consent form.
At the first examination (T0) the clinical oral hygiene parameters will be recorded on the enrolled participants of both the groups and they will be subjected to a professional oral hygiene procedure with appropriate home oral hygiene instructions. The same clinical oral hygiene parameters will be recorded also after 15 days (T1) and after 75 days (T2) from the first examination.
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 (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •legal age
- •pregnancy period between the 14 and 30 week
- •diagnosis positive for pregnancy gingivitis
- •presence of at least 20 teeth
排除标准
- •absumption of alcohol during pregnancy
- •systemic diseases
- •chronic drug assumption
- •allergies
- •ongoing orthodontic therapies
- •positive periodontal screening recording (PSR) at T1
结局指标
主要结局
Periodontal Screening Recording (PSR)
时间窗: 60 Days
Code 0 - Colored area of probe remains completely visible in the deepest crevice in the sextant. No calculus or defective margins are detected. Gingival tissues are healthy with no bleeding after gentle probing. * Code 1 - Colored area of probe remains completely visible in the deepest probing depth in the sextant. No calculus or margins are detected. There is bleeding after gentle probing. * Code 2 - Colored area of probe remains completely visible in the deepest probing depth in the sextant. Supra- or subgingival calculus and/or defective margins are detected. Code 3 - Colored area of probe remains partly visible in the deepest probing depth in the sextant. • Code 4 - Colored area of probe completely disappears, indicating probing depth of greater than 5.5 mm.
次要结局
- Probing Depth (PD)(60 Days)
- Bleeding of Probing (BOP)(60 Days)
- Plaque Index (PI)(60 Days)
研究者
Simona Tecco
Associate Professor
IRCCS San Raffaele