NCT04140643

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2019

Completed
6 months until next milestone

First Posted

Study publicly available on registry

October 28, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

July 29, 2020

Status Verified

July 1, 2020

Enrollment Period

1.8 years

First QC Date

May 3, 2019

Last Update Submit

July 28, 2020

Conditions

Pregnancy GingivitisOzone

Keywords

PregnancyOral HealthOzone therapyGingivitis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Bleeding of Probing (BOP)

    60 Days

  • Plaque Index (PI)

    60 Days

  • Probing Depth (PD)

    60 Days

Study Arms (2)

Ozone therapy

EXPERIMENTAL

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

Only oral hygiene instructions

ACTIVE COMPARATOR

Oral hygiene instructions given by dental hygienist.

Behavioral: Oral hygiene instructions

Interventions

Ozonated water delivering device effects on the oral health of pregnant womenDEVICE

Oral Hygiene instructions and use of an ozonated water delivering device in pregnant women for a period of 75 days.

Ozone therapy
Oral hygiene instructionsBEHAVIORAL

Oral Hygiene instructions

Only oral hygiene instructions

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • legal age
  • pregnancy period between the 14 and 30 week
  • diagnosis positive for pregnancy gingivitis
  • presence of at least 20 teeth

You may not qualify if:

  • absumption of alcohol during pregnancy
  • systemic diseases
  • chronic drug assumption
  • allergies
  • ongoing orthodontic therapies
  • positive periodontal screening recording (PSR) at T1

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dental Clinic, IRCCS San Raffaele Hospital

Milan, MI, 20132, Italy

RECRUITING

Related Publications (5)

  • 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.

    PMID: 24164645BACKGROUND

  • 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.

    PMID: 26608342BACKGROUND

  • 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.

    PMID: 23713644BACKGROUND

  • 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.

    PMID: 28936289BACKGROUND

  • 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.

    PMID: 35887871DERIVED

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

InfectionsGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Enrico Gherlone, MD, MS

    IRCCS San Raffaele Hospital

    STUDY CHAIR

Central Study Contacts

Simona Tecco, DDS, MS, PhD

CONTACT

+39 3297838023tecco.simona@hsr.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 3, 2019

First Posted

October 28, 2019

Study Start

March 1, 2019

Primary Completion

November 30, 2020

Study Completion

December 30, 2020

Last Updated

July 29, 2020

Record last verified: 2020-07

Locations

IT(1)