Ireland
--:--IST
Recruiting Not applicable

Ozone Application Before Fissure Sealants

NCT04040920 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2019-06-17
Last updated
2025-05-16

Condition(s) studied

Caries,Dental

Investigational drug(s) / intervention(s)

OzonePits and fissure sealants

Ozone: One minute of pretreatment with ozone by using the OzoneDTA 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'';

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.

Eligibility

Sex
ALL
Min age
6 Years
Max age
16 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Sealants failure — 12 months after sealant
    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

Trial sites (1)

FacilityCityRegionStatus
Institute for Maternal and Child Health - IRCCS Burlo Garofolo- Trieste Trieste Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04040920 on ClinicalTrials.gov ↗ ← All trials in Italy