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

Ozonized Gel vs Gaseous Ozone Against S. Mutans in Deciduos Molars Caries: Randomized Clinical Trial

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).

Study Overview

• Status: Completed
• Conditions: Dental Caries
• Intervention / Treatment: Other: Ozonized gel; Device: Ozonized water

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Lombardy
    • Pavia, Lombardy, Italy, 27100
      • Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ozone gel group	Other: Ozonized gel; Administration of Ozonized Gel GeliO3
Active Comparator: Gaseous ozone group	Device: Ozonized water; Admininstration of Gaseous ozone (Healozone X4)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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	Scoring criteria: 0.= the subject does not respond to air stimulation; = the subject responds to stimulation with air but does not require interruption;; = the subject responds to stimulation with air and requests interruption or moves away from the stimulus;; = the subject responds to stimulation with air, considers the stimulus painful, requests its interruption or moves away from it.	Baseline (T0), and after 60 seconds (T2)
Gingival Index (calculated on Ramfjiord teeth)	Scoring criteria: 0 = normal gingiva, no inflammation, no erythema, no bleeding; = mild inflammation, slight erythema, minimal superficial alterations, no bleeding; = moderate inflammation, erythema, bleeding on probing; = severe inflammation, severe erythema and swellling, tendency to spontaneous bleeding, possible ulcers	Baseline (T0)
Plaque Index (calculated on Ramfjiord teeth)	Scoring criteria: 0 = no plaque; = thin layer of plaque at the gingival margin, detectable only by scraping with a probe; = moderate layer of plaque along the gingival margin; free interdental spaces, but plaque is visible to the bare eye; = abundant plaque along the gingival margin; plaque-filled interdental spaces.	Baseline (T0)
ICDAS	Scoring criteria: 0 = healthy; = White/brown stain in dry enamel; = White/brown stain on wet enamel; = Microcavity in dry enamel <0.5 mm with no visible dentin; = Dark dentin shade seen through wet enamel with or without microcavity; = Dentin exposure in the cavity> 0.5 mm in the middle of the dry tooth surface; = Dentin exposure in cavity greater than half of the tooth surface	Baseline (T0)
Basic Erosive Wear Examination	Scoring criteria: 0 = no tooth erosion; = superficial enamel loss; = hard tissue loss involving < 50% of tooth surface; = hard tissue loss involving > 50% of tooth surface	Baseline (T0)

Collaborators and Investigators

• Sponsor: University of Pavia
• Investigators: Principal Investigator: Andrea Scribante, DDS, PhD, University of Pavia

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2024
• Primary Completion (Actual): April 1, 2025
• Study Completion (Actual): April 5, 2025

Study Registration Dates

• First Submitted: October 11, 2024
• First Submitted That Met QC Criteria: October 11, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): April 16, 2025
• Last Update Submitted That Met QC Criteria: April 15, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth Demineralization; Dental Caries
• Other Study ID Numbers: 2024-OZONECARIES

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be available upon motivated request to the corresponding authors.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No