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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ozone therapy | Experimental | Ozone application before pits and fissure sealants |
|
| Pits and fissure sealants | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ozone | Device | One minute of pretreatment with ozone by using the OzoneDTA device |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Milena Cadenaro, DDS,MSc,PhD | Contact | +390403785358 | milena.cadenaro@burlo.trieste.it | |
| Chiara Navarra, DDS,MSc,PhD | Contact | +390403785358 | chiara.navarra@burlo.trieste.it |
| Name | Affiliation | Role |
|---|---|---|
| Milena Cadenaro, DDS,MSc,PhD | IRCCS Burlo Garofolo | Study Chair |
| Maddalena Chermetz, DDS,MSc | IRCCS Burlo Garofolo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute for Maternal and Child Health - IRCCS Burlo Garofolo- | Recruiting | Trieste | Trieste | 34137 | Italy |
Data collected during the study will be available from the Study Director on reasonable request after evaluation of a protocol approved by an Ethical Committee
After publication of data on peer reviewed journals
Data collected during the study will be available from the Study Director on reasonable request after evaluation of a protocol approved by an Ethical Committee
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D010895 | Pit and Fissure Sealants |
| ID | Term |
|---|---|
| D003764 | Dental Materials |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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Splith mouth design
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| 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''; |
|
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 |