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

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.

Study Overview

• Status: Unknown
• Conditions: Ozone; Pregnancy Gingivitis
• Intervention / Treatment: Device: Ozonated water delivering device effects on the oral health of pregnant women; Behavioral: Oral hygiene instructions

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Simona Tecco, DDS, MS, PhD; Phone Number: +39 3297838023; Email: tecco.simona@hsr.it

Study Locations

• Italy
  • MI
    • Milan, MI, Italy, 20132
      • Recruiting
      • Dental Clinic, IRCCS San Raffaele Hospital
      • Contact: Simona Tecco, DDS, MS, PhD; Phone Number: +39 3297838023; Email: tecco.simona@hsr.it
      • Principal Investigator: Simona Tecco, DDS, MS, PhD
      • Sub-Investigator: Teresa D'Amicantonio, BSDH
      • Sub-Investigator: Gabriella Pasini, BSDH
      • Sub-Investigator: Marika Monti, BSDH student
      • Sub-Investigator: Alessandro Nota, DDS, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ozone therapy; 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; Oral Hygiene instructions and use of an ozonated water delivering device in pregnant women for a period of 75 days.
Active Comparator: Only oral hygiene instructions; Oral hygiene instructions given by dental hygienist.	Behavioral: Oral hygiene instructions; Oral Hygiene instructions

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: IRCCS San Raffaele
• Investigators: Study Chair: Enrico Gherlone, MD, MS, IRCCS San Raffaele Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Anticipated): November 30, 2020
• Study Completion (Anticipated): December 30, 2020

Study Registration Dates

• First Submitted: May 3, 2019
• First Submitted That Met QC Criteria: October 24, 2019
• First Posted (Actual): October 28, 2019

Study Record Updates

• Last Update Posted (Actual): July 29, 2020
• Last Update Submitted That Met QC Criteria: July 28, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Pregnancy; Oral Health; Gingivitis; Ozone therapy
• Additional Relevant MeSH Terms: Infections; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Gingivitis
• Other Study ID Numbers: EB2C

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No