Dental CariesNCT06641323
Ozonized Gel vs Gaseous Ozone Against S. Mutans in Deciduos Molars Caries
A study testing Ozonized gel and Ozonized water in people with Dental Caries, run by University of Pavia at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Dental Caries
- What is being tested?
- Ozonized gel and Ozonized water
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteItaly
- Study dates
- 21 Oct 2024to 5 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients suffering from carious lesion on viable deciduous molar
- patients' compliance
Who cannot join
- patients with early loss of deciduous molars for carious lesions or orthodontic reasons
- non-viable deciduous molars
- deciduous molars with traumatic lesions
Trial locations and contacts
1 site in 1 country.
Italy1 site
Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia
Pavia, Lombardy, 27100
About this study
Official title: 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.
Read more
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
- Being tested
- Ozonized gel, Ozonized water
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ozonized gelOther
Administration of Ozonized Gel GeliO3
Ozonized waterDevice
Admininstration of Gaseous ozone (Healozone X4)
| Study group | Role | What they receive |
|---|---|---|
| Ozone gel group | Experimental | Not described Receives: Other: Ozonized gel |
| Gaseous ozone group | Active comparator | Not described Receives: Device: Ozonized water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in S. mutans counts
Evaluation of Colony forming units (CFU) of bacterials samples after treatment.
Measured: Baseline (T0), after 30 seconds (T1) and after 60 seconds (T2)
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: Baseline (T0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start21 Oct 2024
- Primary completion1 Apr 2025
- Study completion5 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Scribante, University of Pavia
- Investigators
- Andrea Scribante, DDS, PhD, Principal investigator, University of Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06641323
- Sponsor's protocol ID
- 2024-OZONECARIES
- Status last verified
- Apr 2025
- First submitted
- 11 Oct 2024
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be available upon motivated request to the corresponding authors.
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ozonized Gel vs Gaseous Ozone Against S. Mutans in Deciduos Molars Caries: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06641323
- Acronym / sponsor ID
- 2024-OZONECARIES
- Conditions
- Dental Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Study start
- 21 Oct 2024 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 5 Apr 2025 (actual)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ozone gel group | Experimental | Other: Ozonized gel |
| Gaseous ozone group | Active comparator | Device: Ozonized water |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Patients suffering from carious lesion on viable deciduous molar
- patients' compliance
Key exclusion criteria (3 listed)
- patients with early loss of deciduous molars for carious lesions or orthodontic reasons
- non-viable deciduous molars
- deciduous molars with traumatic lesions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ozonized gelAdministration of Ozonized Gel GeliO3 | Other | Ozone gel group |
| Ozonized waterAdmininstration of Gaseous ozone (Healozone X4) | Device | Gaseous ozone group |
Primary outcome
Change in S. mutans counts
Time frame: Baseline (T0), after 30 seconds (T1) and after 60 seconds (T2)
Evaluation of Colony forming units (CFU) of bacterials samples after treatment.
6 secondary outcomes
Change in FLACC
Time frame: Baseline (T0), and after 60 seconds (T2)
Change in Schiff Air Index
Time frame: Baseline (T0), and after 60 seconds (T2)
Gingival Index (calculated on Ramfjiord teeth)
Time frame: Baseline (T0)
Plaque Index (calculated on Ramfjiord teeth)
Time frame: Baseline (T0)
ICDAS
Time frame: Baseline (T0)
Basic Erosive Wear Examination
Time frame: Baseline (T0)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Individual participant dataSharing planned: No. Data will be available upon motivated request to the corresponding authors.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Scribante, DDS, PhD principal investigator
University of Pavia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ozonized gel and Ozonized water in people with Dental Caries, run by University of Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in S. mutans counts (time frame: Baseline (T0), after 30 seconds (T1) and after 60 seconds (T2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.