Ozone Application Before Fissure Sealants

The Effect of Ozone Application Before Fissure Sealants: a Split Mouth Randomized Controlled Trial

Decay is a multifactorial infective degenerative disease of hard dental tissues, caused by Streptococcus mutans and Lactobacillus forming the bacterial biofilm of teeth surfaces. Decays generally evolve in fissures and pits of secondary molars. Pits and fissure sealants prevent decays if performed in two years from eruption. Ozone has bactericidal effect and remineralizing capacity on enamel.

The aim of this study is to assess the effectiveness of ozone application before sealants in increasing their duration in time.

Study Overview

• Status: Recruiting
• Conditions: Caries,Dental
• Intervention / Treatment: Device: Ozone; Other: Pits and fissure sealants

• Study Type: Interventional
• Enrollment (Estimated): 67
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Milena Cadenaro, DDS,MSc,PhD; Phone Number: +390403785358; Email: milena.cadenaro@burlo.trieste.it
• Study Contact Backup: Name: Chiara Navarra, DDS,MSc,PhD; Phone Number: +390403785358; Email: chiara.navarra@burlo.trieste.it

Study Locations

• Italy
  • Trieste, Italy, 34137
    • Recruiting
    • Institute for Maternal and Child Health - IRCCS Burlo Garofolo-
    • Contact: Milena Cadenaro; Email: milena.cadenaro@burlo.trieste.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 16 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• first or second secondary molars to be sealed
• possibility to isolate with rubber dam both the teeth involved
• no clear signs of pigmentations
• good general health

Exclusion Criteria:

• latex allergy
• epilepsy or other severe neurological pathologies
• psychiatric disease
• excessive sensibility to electrical current
• severe asthma
• enamel disorders, such as amelogenesis imperfect, white spots, fluorosis or Molar Incisors Hypomineralization

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ozone therapy; Ozone application before pits and fissure sealants	Device: Ozone; One minute of pretreatment with ozone by using the OzoneDTA device; Other: Pits and fissure sealants; cleansing of the occlusal surfaces with a nylon brush and polishing toothpaste; surface etching with 36% orthophosphoric acid for 30'', surface cleaning and drying for 30 '', application of the sealing material, polymerization for 60'';
Active Comparator: Pits and fissure sealants	Other: Pits and fissure sealants; cleansing of the occlusal surfaces with a nylon brush and polishing toothpaste; surface etching with 36% orthophosphoric acid for 30'', surface cleaning and drying for 30 '', application of the sealing material, polymerization for 60'';

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sealants failure	Frequency of sealed failure defined as presence of to one or more of these outcomes: Marginal fissure; Sealant fracture; Decay; Marginal pigmentations; Sealant detachment Evaluation of the relative frequency of the different causes of failure	12 months after sealant

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sealants failure	Frequency of sealed failure defined as presence of to one or more of these outcomes: Marginal fissure; Sealant fracture; Decay; Marginal pigmentations; Sealant detachment Evaluation of the relative frequency of the different causes of failure	6 months after sealant
Sealants failure	Frequency of sealed failure defined as presence of to one or more of these outcomes: Marginal fissure; Sealant fracture; Decay; Marginal pigmentations; Sealant detachment Evaluation of the relative frequency of the different causes of failure	24 months after sealant
Secondary decay in failed sealants	Frequency of secondary decay in teeth with failed sealants	6 months after sealant
Secondary decay in failed sealants	Frequency of secondary decay in teeth with failed sealants	12 months after sealant
Secondary decay in failed sealants	Frequency of secondary decay in teeth with failed sealants	24 months after sealant

Collaborators and Investigators

• Sponsor: IRCCS Burlo Garofolo
• Investigators: Study Chair: Milena Cadenaro, DDS,MSc,PhD, IRCCS Burlo Garofolo; Principal Investigator: Maddalena Chermetz, DDS,MSc, IRCCS Burlo Garofolo

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2019
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: July 30, 2019
• First Submitted That Met QC Criteria: July 30, 2019
• First Posted (Actual): August 1, 2019

Study Record Updates

• Last Update Posted (Actual): May 16, 2025
• Last Update Submitted That Met QC Criteria: May 13, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Prevention; Ozone; Pits and fissures sealants
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth Demineralization; Dental Caries
• Other Study ID Numbers: RC 02/2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data collected during the study will be available from the Study Director on reasonable request after evaluation of a protocol approved by an Ethical Committee
• IPD Sharing Time Frame: After publication of data on peer reviewed journals
• IPD Sharing Access Criteria: Data collected during the study will be available from the Study Director on reasonable request after evaluation of a protocol approved by an Ethical Committee
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

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