Ozone Application Before Fissure Sealants

Study Overview
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Brief Summary
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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.

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

Conditions
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Caries,Dental

Intervention / Treatment
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* Device: Ozone
* Other: Pits and fissure sealants


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Splith mouth design
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ozone therapy<br>Ozone application before pits and fissure sealants | Device: Ozone<br>* One minute of pretreatment with ozone by using the OzoneDTA device<br>Other: Pits and fissure sealants<br>* 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'';<br>|
| Active Comparator: Pits and fissure sealants<br> | Other: Pits and fissure sealants<br>* 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'';<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 12 months after sealant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6 months after sealant | 
| 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 | 24 months after sealant | 
| Secondary decay in failed sealants | Frequency of secondary decay in teeth with failed sealants | 6 months after sealant | 
| Secondary decay in failed sealants | Frequency of secondary decay in teeth with failed sealants | 12 months after sealant | 
| Secondary decay in failed sealants | Frequency of secondary decay in teeth with failed sealants | 24 months after sealant | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ozone, Pits and fissures sealants, Prevention