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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 dentin, a bacterial sample will be taken from the carious surface with a sterile paper cone at time T0; then ozone will be applied for 30 seconds, the surface will be washed with sterile saline and dried with air, a second sample will be taken at time T2; finally, ozone will be applied for another 30 seconds, the surface will be washed with sterile saline and dried with air, a third sample will be taken at time T2.
Patients are then randomised into two groups:
Test group: gaseous ozone (Healozone X4) is applied to the carious lesion for 30 seconds and then for another 30 seconds.
Control group: ozone gel (GeliO3) will be applied to the carious lesion for 30 seconds and then for another 30 seconds.
Changes in the following indices will be assessed at the first visit and when the samples are taken at 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 severity of enamel erosion (Bewe index).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ozone gel group | Experimental |
| |
| Gaseous ozone group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ozonized gel | Other | Administration of Ozonized Gel GeliO3 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in S. mutans counts | Evaluation of Colony forming units (CFU) of bacterials samples after treatment. | Baseline (T0), after 30 seconds (T1) and after 60 seconds (T2) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in FLACC | The FLACC scale or Face, Legs, Activity, Cry, Consolability scale is a measurement used to assess pain for children with a score of 0 to 2 for each evaluation. | Baseline (T0), and after 60 seconds (T2) |
| Change in Schiff Air Index |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrea Scribante, DDS, PhD | University of Pavia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia | Pavia | Lombardy | 27100 | Italy |
Data will be available upon motivated request to the corresponding authors.
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| Ozonized water |
| Device |
Admininstration of Gaseous ozone (Healozone X4) |
|
Scoring criteria:
0.= the subject does not respond to air stimulation;
| Baseline (T0), and after 60 seconds (T2) |
| Gingival Index (calculated on Ramfjiord teeth) | Scoring criteria: 0 = normal gingiva, no inflammation, no erythema, no bleeding
| Baseline (T0) |
| Plaque Index (calculated on Ramfjiord teeth) | Scoring criteria: 0 = no plaque
| Baseline (T0) |
| ICDAS | Scoring criteria: 0 = healthy
| Baseline (T0) |
| Basic Erosive Wear Examination | Scoring criteria: 0 = no tooth erosion
| Baseline (T0) |