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Ozone Application Before Fissure Sealants

NCT04040920 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2025-05-16

No results posted yet for this study

Summary

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.

Conditions

  • Caries,Dental

Interventions

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'';

Sponsors & Collaborators

  • IRCCS Burlo Garofolo

    lead OTHER

Principal Investigators

  • Milena Cadenaro, DDS,MSc,PhD · IRCCS Burlo Garofolo

  • Maddalena Chermetz, DDS,MSc · IRCCS Burlo Garofolo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-17
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04040920 on ClinicalTrials.gov