Ozone Application Before Fissure Sealants

NCT ID: NCT04040920

Last Updated: 2025-05-16

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-17

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Caries,Dental

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Splith mouth design
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Ozone therapy

Ozone application before pits and fissure sealants

Group Type EXPERIMENTAL

Ozone

Intervention Type DEVICE

One minute of pretreatment with ozone by using the OzoneDTA device

Pits and fissure sealants

Intervention Type OTHER

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'';

Pits and fissure sealants

Group Type ACTIVE_COMPARATOR

Pits and fissure sealants

Intervention Type OTHER

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'';

Interventions

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Ozone

One minute of pretreatment with ozone by using the OzoneDTA device

Intervention Type DEVICE

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'';

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS Burlo Garofolo

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Milena Cadenaro, DDS,MSc,PhD

Role: STUDY_CHAIR

IRCCS Burlo Garofolo

Maddalena Chermetz, DDS,MSc

Role: PRINCIPAL_INVESTIGATOR

IRCCS Burlo Garofolo

Locations

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Institute for Maternal and Child Health - IRCCS Burlo Garofolo-

Trieste, Trieste, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Milena Cadenaro, DDS,MSc,PhD

Role: CONTACT

+390403785358

Chiara Navarra, DDS,MSc,PhD

Role: CONTACT

+390403785358

Facility Contacts

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Milena Cadenaro

Role: primary

Other Identifiers

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RC 02/2019

Identifier Type: -

Identifier Source: org_study_id

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