Ozone Clinical Trial
Official title:
Ozone Therapy as an Aid for Home Oral Hygiene. The Use of Aquolab in the Pregnant Woman.
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.
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.
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.
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