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

NCT ID: NCT06641323

Last Updated: 2025-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-21
• Study Completion Date: 2025-04-05

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).

Conditions

Dental Caries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Ozone gel group

Group Type: EXPERIMENTAL

Ozonized gel

Intervention Type: OTHER

Administration of Ozonized Gel GeliO3

Gaseous ozone group

Group Type: ACTIVE_COMPARATOR

Ozonized water

Intervention Type: DEVICE

Admininstration of Gaseous ozone (Healozone X4)

Interventions

Ozonized gel

Administration of Ozonized Gel GeliO3

Intervention Type: OTHER

Ozonized water

Admininstration of Gaseous ozone (Healozone X4)

Intervention Type: DEVICE

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pavia

OTHER

Sponsor Role: lead

Responsible Party

Andrea Scribante

Associate Professor, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrea Scribante, DDS, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pavia

Locations

Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia

Pavia, Lombardy, Italy

Countries

Italy

Other Identifiers

2024-OZONECARIES

Identifier Type: -

Identifier Source: org_study_id