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Ozone Application Before Fissure Sealants

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04040920
Enrollment
67
Registered
2019-08-01
Start date
2019-06-17
Completion date
2026-12-31
Last updated
2025-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Caries,Dental

Keywords

Ozone, Pits and fissures sealants, Prevention

Brief 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.

Interventions

DEVICEOzone

One minute of pretreatment with ozone by using the OzoneDTA device

OTHERPits 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

IRCCS Burlo Garofolo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Intervention model description

Splith mouth design

Eligibility

Sex/Gender
ALL
Age
6 Years to 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

Design outcomes

Primary

MeasureTime frameDescription
Sealants failure12 months after sealantFrequency 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

Secondary

MeasureTime frameDescription
Sealants failure6 months after sealantFrequency 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
Secondary decay in failed sealants6 months after sealantFrequency of secondary decay in teeth with failed sealants

Countries

Italy

Contacts

Primary ContactMilena Cadenaro, DDS,MSc,PhD
milena.cadenaro@burlo.trieste.it+390403785358
Backup ContactChiara Navarra, DDS,MSc,PhD
chiara.navarra@burlo.trieste.it+390403785358

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026