Ozone Therapy for the Home Oral Hygiene of the Pregnant Woman.
NCT ID: NCT04140643
Last Updated: 2020-07-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2019-03-01
2020-12-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Ozone therapy
Oral hygiene instructions given by dental hygienist and home daily use of ozonated water delivering system.
Ozonated water delivering device effects on the oral health of pregnant women
Oral Hygiene instructions and use of an ozonated water delivering device in pregnant women for a period of 75 days.
Only oral hygiene instructions
Oral hygiene instructions given by dental hygienist.
Oral hygiene instructions
Oral Hygiene instructions
Interventions
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Ozonated water delivering device effects on the oral health of pregnant women
Oral Hygiene instructions and use of an ozonated water delivering device in pregnant women for a period of 75 days.
Oral hygiene instructions
Oral Hygiene instructions
Eligibility Criteria
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Inclusion Criteria
* pregnancy period between the 14 and 30 week
* diagnosis positive for pregnancy gingivitis
* presence of at least 20 teeth
Exclusion Criteria
* systemic diseases
* chronic drug assumption
* allergies
* ongoing orthodontic therapies
* positive periodontal screening recording (PSR) at T1
18 Years
45 Years
FEMALE
Yes
Sponsors
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IRCCS San Raffaele
OTHER
Responsible Party
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Simona Tecco
Associate Professor
Principal Investigators
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Enrico Gherlone, MD, MS
Role: STUDY_CHAIR
IRCCS San Raffaele Hospital
Locations
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Dental Clinic, IRCCS San Raffaele Hospital
Milan, MI, Italy
Countries
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Central Contacts
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Facility Contacts
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References
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Geisinger ML, Geurs NC, Bain JL, Kaur M, Vassilopoulos PJ, Cliver SP, Hauth JC, Reddy MS. Oral health education and therapy reduces gingivitis during pregnancy. J Clin Periodontol. 2014 Feb;41(2):141-8. doi: 10.1111/jcpe.12188. Epub 2013 Nov 19.
Jiang H, Xiong X, Buekens P, Su Y, Qian X. Use of mouth rinse during pregnancy to improve birth and neonatal outcomes: a randomized controlled trial. BMC Pregnancy Childbirth. 2015 Nov 25;15:311. doi: 10.1186/s12884-015-0761-3.
Villa A, Abati S, Pileri P, Calabrese S, Capobianco G, Strohmenger L, Ottolenghi L, Cetin I, Campus GG. Oral health and oral diseases in pregnancy: a multicentre survey of Italian postpartum women. Aust Dent J. 2013 Jun;58(2):224-9. doi: 10.1111/adj.12058. Epub 2013 May 5.
Almerich-Silla JM, Alminana-Pastor PJ, Boronat-Catala M, Bellot-Arcis C, Montiel-Company JM. Socioeconomic factors and severity of periodontal disease in adults (35-44 years). A cross sectional study. J Clin Exp Dent. 2017 Aug 1;9(8):e988-e994. doi: 10.4317/jced.54033. eCollection 2017 Aug.
Tecco S, Nota A, D'Amicantonio T, Pittari L, Monti M, Polizzi E. Effects of an Ozonated Water Irrigator on the Plaque Index and Bleeding Index of Pregnant Women. J Clin Med. 2022 Jul 15;11(14):4107. doi: 10.3390/jcm11144107.
Other Identifiers
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EB2C
Identifier Type: -
Identifier Source: org_study_id
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