Ozone Therapy for the Home Oral Hygiene of the Pregnant Woman.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Ozone Therapy as an Aid for Home Oral Hygiene. The Use of Aquolab in the Pregnant Woman.

Conditions
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Pregnancy Gingivitis, Ozone

Intervention / Treatment
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* Device: Ozonated water delivering device effects on the oral health of pregnant women
* Behavioral: Oral hygiene instructions


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: legal age pregnancy period between the 14 and 30 week diagnosis positive for pregnancy gingivitis presence of at least 20 teeth Exclusion Criteria: absumption of alcohol during pregnancy systemic diseases chronic drug assumption allergies ongoing orthodontic therapies positive periodontal screening recording (PSR) at T1

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ozone therapy<br>Oral hygiene instructions given by dental hygienist and home daily use of ozonated water delivering system. | Device: Ozonated water delivering device effects on the oral health of pregnant women<br>* Oral Hygiene instructions and use of an ozonated water delivering device in pregnant women for a period of 75 days.<br>|
| Active Comparator: Only oral hygiene instructions<br>Oral hygiene instructions given by dental hygienist. | Behavioral: Oral hygiene instructions<br>* Oral Hygiene instructions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Periodontal Screening Recording (PSR) | 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. | 60 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding of Probing (BOP) | Expressed as Full Mouth Bleeding Score (FMPS), percentage of bleeding sites on the total number of available sites. | 60 Days | 
| Plaque Index (PI) | Expressed as Full Mouth Plaque Score (FMPS), percentage of plaque containing dental surfaces on the total number of available surfaces. | 60 Days | 
| Probing Depth (PD) |  | 60 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregnancy, Oral Health, Ozone therapy, Gingivitis