Clinical trial NCT06641323: Ozonized Gel vs Gaseous Ozone Against S. Mutans in Deciduos Molars Caries
Official title: Ozonized Gel vs Gaseous Ozone Against S. Mutans in Deciduos Molars Caries: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Lead sponsor: University of Pavia
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 16
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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).


Eligibility criteria: Inclusion Criteria:

* Patients suffering from carious lesion on viable deciduous molar
* patients' compliance

Exclusion Criteria:

* patients with early loss of deciduous molars for carious lesions or orthodontic reasons
* non-viable deciduous molars
* deciduous molars with traumatic lesions

Primary outcomes:
measure: Change in S. mutans counts
timeFrame: Baseline (T0), after 30 seconds (T1) and after 60 seconds (T2)
Secondary outcomes:
measure: Change in FLACC
timeFrame: Baseline (T0), and after 60 seconds (T2)
measure: Change in Schiff Air Index
timeFrame: Baseline (T0), and after 60 seconds (T2)
measure: Gingival Index (calculated on Ramfjiord teeth)
timeFrame: Baseline (T0)
measure: Plaque Index (calculated on Ramfjiord teeth)
timeFrame: Baseline (T0)
measure: ICDAS
timeFrame: Baseline (T0)
measure: Basic Erosive Wear Examination
timeFrame: Baseline (T0)
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia
state: Lombardy
Study officials:
affiliation: University of Pavia
name: Andrea Scribante, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References: