An interventional study of Ozone and Pits and fissure sealants in Caries,Dental, sponsored by IRCCS Burlo Garofolo. Recruiting at 1 site in Italy. Open to participants aged 6 Years to 16 Years. Per ClinicalTrials.gov, last updated 2025-05-16.
Sponsored by IRCCS Burlo Garofolo · Not applicable, Interventional, and Treatment
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.
1,171 studies on the registry are indexed under Dental Caries; 209 are open to participants now.
This study's planned enrollment of 67 is above the median of 60 across 967 interventional studies indexed under Dental Caries.
Browse Dental Caries studies →IRCCS Burlo Garofolo is the lead sponsor of 89 studies on the registry; 32 are open to participants now.
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Exclusion Criteria:
Ozone application before pits and fissure sealants
Device: Ozone · Other: Pits and fissure sealants
Other: Pits and fissure sealants
One minute of pretreatment with ozone by using the OzoneDTA device
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'';
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 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
Time frame: 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
Time frame: 24 months after sealant
Secondary decay in failed sealants
Frequency of secondary decay in teeth with failed sealants
Time frame: 6 months after sealant
Secondary decay in failed sealants
Frequency of secondary decay in teeth with failed sealants
Time frame: 12 months after sealant
Secondary decay in failed sealants
Frequency of secondary decay in teeth with failed sealants
Time frame: 24 months after sealant
Plan to share: Yes — 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
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: After publication of data on peer reviewed journals
Access criteria: 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
No publications or documents are linked to this record.
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IRCCS Burlo Garofolo