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

NCT06641323 | Completed

• 1 other identifier: 2024-OZONECARIES
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (6)

• Change in FLACC

  Baseline (T0), and after 60 seconds (T2)

• Change in Schiff Air Index

  Baseline (T0), and after 60 seconds (T2)

• Gingival Index (calculated on Ramfjiord teeth)

  Baseline (T0)

• Plaque Index (calculated on Ramfjiord teeth)

  Baseline (T0)

• ICDAS

  Baseline (T0)

Study Arms (2)

Ozone gel group

EXPERIMENTAL

Other: Ozonized gel

Gaseous ozone group

ACTIVE COMPARATOR

Device: Ozonized water

Interventions

Ozonized gel OTHER

Administration of Ozonized Gel GeliO3

Ozone gel group

Ozonized water DEVICE

Admininstration of Gaseous ozone (Healozone X4)

Gaseous ozone group

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Pavia: lead

Study Sites (1)

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

Pavia, Lombardy, 27100, Italy

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Andrea Scribante, DDS, PhD

  University of Pavia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Principal Investigator

Study Record Dates

• First Submitted: October 11, 2024
• First Posted: October 15, 2024
• Study Start: October 21, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 5, 2025
• Last Updated: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)