Ozone Application Before Fissure Sealants
ConditionCaries,Dental
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-16
SponsorIRCCS Burlo Garofolo
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
latex allergy
epilepsy or other severe neurological pathologies
psychiatric disease
excessive sensibility to electrical current
Trial design
Design model
Parallel
Treatments tested in this trial
Ozone
DeviceOne minute of pretreatment with ozone by using the OzoneDTA device
Pits and fissure sealants
Other interventioncleansing 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'';
Treatment groups
67 Participants
are divided into 2 treatment groupsGroup A: Ozone therapyExperimental treatment 2 interventions
Group B: Pits and fissure sealantsActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Sealants failure
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
Time frame
12 months after sealantSecondary outcomes
1
Sealants failure
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
Time frame
6 months after sealant2
Sealants failure
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
Time frame
24 months after sealant3
Secondary decay in failed sealants
Frequency of secondary decay in teeth with failed sealants
Time frame
6 months after sealant4
Secondary decay in failed sealants
Frequency of secondary decay in teeth with failed sealants
Time frame
12 months after sealantSponsors and contacts
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Source ClinicalTrials.gov