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NCT Number: NCT04040920

Ozone Application Before Fissure Sealants

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.

Recruiting

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Key information

Conditions

Caries,Dental Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

6 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute for Maternal and Child Health - IRCCS Burlo Garofolo-

Trieste, 34137, Italy

Location status: Recruiting

Location contact

Milena Cadenaro

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ozone

Device

One minute of pretreatment with ozone by using the OzoneDTA device

Pits and fissure sealants

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'';

Primary outcomes

  1. Sealants failure

    Time frame: 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

Secondary outcomes

  1. Sealants failure

    Time frame: 6 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

  2. Sealants failure

    Time frame: 24 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

  3. Secondary decay in failed sealants

    Time frame: 6 months after sealant

    Frequency of secondary decay in teeth with failed sealants

  4. Secondary decay in failed sealants

    Time frame: 12 months after sealant

    Frequency of secondary decay in teeth with failed sealants

  5. Secondary decay in failed sealants

    Time frame: 24 months after sealant

    Frequency of secondary decay in teeth with failed sealants

Study contacts

Contact information is provided by the study sponsor or research team.

Chiara Navarra, DDS,MSc,PhD

CONTACT

[email protected]

+390403785358

Milena Cadenaro, DDS,MSc,PhD

CONTACT

[email protected]

+390403785358

Sponsors and collaborators

Lead sponsor

IRCCS Burlo Garofolo

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Aug 1, 2019
Registry last updated
May 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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