Ozonized Gel vs Gaseous Ozone Against S. Mutans in Deciduos Molars Caries

University of Pavia

Status: Completed

Conditions: Dental Caries

Treatments: Device: Ozonized water; Other: Ozonized gel

Study type: Interventional

Funder types: Other

Identifiers

NCT06641323

2024-OZONECARIES

Details and patient eligibility

About

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).

Enrollment: 16 patients

Sex: All

Ages: 4 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

16 participants in 2 patient groups

Ozone gel group

Experimental group

Treatment:

Other: Ozonized gel

Gaseous ozone group

Active Comparator group

Treatment:

Device: Ozonized water