Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06641323
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-11
Brief Title:
Ozonized Gel vs Gaseous Ozone Against S Mutans in Deciduos Molars Caries
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Ozonized Gel vs Gaseous Ozone Against S Mutans in Deciduos Molars Caries Randomized Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to verify through bacteriological analysis the efficacy of reducing the bacterial load referred to the presence of Streptococcus Mutans in carious lesions of viable deciduous molars by application of gaseous ozone or ozonized gel
Patients who meet the eligibility criteria and for whom the legal guardians have signed the informed consent will undergo treatment of the carious lesion with gaseous ozone or ozonized gel After selective removal of the dentin a sample of bacteria from the the carious surface will be collected with a sterile paper cone at time T0 then ozone will be applied for 30 seconds the surface is washed with sterile saline and dried with air a second sample is taken at time T2 finally ozone is applied for other 30 seconds the surface is washed with sterile saline and dried with air a third sample is taken at time T2
Then patients will be randomly divided into two groups
Test group gaseous ozone Healozone X4 will be administered on the carious lesion for 30 seconds and then for other 30 seconds
Control group ozone gel GeliO3 will be administered on the carious lesion for 30 seconds and then for other 30 seconds
Changes in the following indices will be assessed during the first visit and the execution of the samples at time frames T0 T1 T2 compliance assessment FLACC scale sensitivity test Schiff Air Index assessment of lesion severity and extent ICDAS assessment of gingival inflammation GI assessment of plaque index PI assessment of the severity of enamel erosion Bewe index
Patients who meet the eligibility criteria and for whom the legal guardians have signed the informed consent will undergo treatment of the carious lesion with gaseous ozone or ozonized gel After selective removal of the dentin a sample of bacteria from the the carious surface will be collected with a sterile paper cone at time T0 then ozone will be applied for 30 seconds the surface is washed with sterile saline and dried with air a second sample is taken at time T2 finally ozone is applied for other 30 seconds the surface is washed with sterile saline and dried with air a third sample is taken at time T2
Then patients will be randomly divided into two groups
Test group gaseous ozone Healozone X4 will be administered on the carious lesion for 30 seconds and then for other 30 seconds
Control group ozone gel GeliO3 will be administered on the carious lesion for 30 seconds and then for other 30 seconds
Changes in the following indices will be assessed during the first visit and the execution of the samples at time frames T0 T1 T2 compliance assessment FLACC scale sensitivity test Schiff Air Index assessment of lesion severity and extent ICDAS assessment of gingival inflammation GI assessment of plaque index PI assessment of the severity of enamel erosion Bewe index
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None