NCT04140643

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

Status unknown NA Last updated 29 July 2020

What this trial tests

NA trial testing Ozonated water delivering device effects on the oral health of pregnant women in Pregnancy Gingivitis in 60 participants. Status unknown.

Timeline

1 March 2019

Primary endpoint
30 November 2020

30 December 2020

Quick facts

Lead sponsor	IRCCS San Raffaele
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	60
Start date	1 March 2019
Primary completion	30 November 2020
Estimated completion	30 December 2020
Sites	1 location across Italy

Drugs / interventions tested

• Ozonated water delivering device effects on the oral health of pregnant women
• Oral hygiene instructions

Conditions studied

• Pregnancy Gingivitis — all drugs for Pregnancy Gingivitis →
• Ozone — all drugs for Ozone →

Sponsor

IRCCS San Raffaele — full company profile →

Who can join

Adults 18 to 45, female only, with Pregnancy Gingivitis or Ozone. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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.

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effects of an Ozonated Water Irrigator on the Plaque Index and Bleeding Index of Pregnant Women.
   Tecco S, Nota A, D'Amicantonio T, Pittari L, et al · · 2022 · cited 5× · PMID 35887871 · DOI 10.3390/jcm11144107