Caries,DentalNCT04040920
Ozone Application Before Fissure Sealants
A study testing Ozone and Pits and fissure sealants in people with Caries,Dental, run by IRCCS Burlo Garofolo at 1 site in Italy.
Trial summary
Decay is a multifactorial infective degenerative disease of hard dental tissues, caused by Streptococcus mutans and Lactobacillus forming the bacterial biofilm of teeth surfaces. Decays generally evolve in fissures and pits of secondary molars. Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Caries,Dental
- What is being tested?
- Ozone and Pits and fissure sealants
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteItaly
- Study dates
- 17 Jun 2019to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- first or second secondary molars to be sealed
- possibility to isolate with rubber dam both the teeth involved
- no clear signs of pigmentations
- good general health
Who cannot join
- latex allergy
- epilepsy or other severe neurological pathologies
- psychiatric disease
- excessive sensibility to electrical current
- severe asthma
- enamel disorders, such as amelogenesis imperfect, white spots, fluorosis or Molar Incisors Hypomineralization
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Institute for Maternal and Child Health - IRCCS Burlo Garofolo-
Trieste, Trieste, 34137
Milena Cadenaro, milena.cadenaro@burlo.trieste.it
About this study
Official title: The Effect of Ozone Application Before Fissure Sealants: a Split Mouth Randomized Controlled Trial
Decay is a multifactorial infective degenerative disease of hard dental tissues, caused by Streptococcus mutans and Lactobacillus forming the bacterial biofilm of teeth surfaces. Decays generally evolve in fissures and pits of secondary molars. Pits and fissure sealants prevent decays if performed in two years from eruption. Ozone has bactericidal effect and remineralizing capacity on enamel.
The aim of this study is to assess the effectiveness of ozone application before sealants in increasing their duration in time.
- Conditions
- Caries,Dental
- Being tested
- Ozone, Pits and fissure sealants
- Keywords
- Ozone, Pits and fissures sealants, Prevention
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OzoneDevice
One minute of pretreatment with ozone by using the OzoneDTA device
Pits and fissure sealantsOther
cleansing of the occlusal surfaces with a nylon brush and polishing toothpaste; surface etching with 36% orthophosphoric acid for 30'', surface cleaning and drying for 30 '', application of the sealing material, polymerization for 60'';
| Study group | Role | What they receive |
|---|---|---|
| Ozone therapy | Experimental | Ozone application before pits and fissure sealants Receives: Device: Ozone; Other: Pits and fissure sealants |
| Pits and fissure sealants | Active comparator | Not described Receives: Other: Pits and fissure sealants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sealants failure
Frequency of sealed failure defined as presence of to one or more of these outcomes: Marginal fissure; Sealant fracture; Decay; Marginal pigmentations; Sealant detachment Evaluation of the relative frequency of the different causes of failure
Measured: 12 months after sealant
Secondary outcomes (5)
Sealants failure
Frequency of sealed failure defined as presence of to one or more of these outcomes: Marginal fissure; Sealant fracture; Decay; Marginal pigmentations; Sealant detachment Evaluation of the relative frequency of the different causes of failure
Measured: 6 months after sealant
Sealants failure
Frequency of sealed failure defined as presence of to one or more of these outcomes: Marginal fissure; Sealant fracture; Decay; Marginal pigmentations; Sealant detachment Evaluation of the relative frequency of the different causes of failure
Measured: 24 months after sealant
Secondary decay in failed sealants
Frequency of secondary decay in teeth with failed sealants
Measured: 6 months after sealant
Secondary decay in failed sealants
Frequency of secondary decay in teeth with failed sealants
Measured: 12 months after sealant
Secondary decay in failed sealants
Frequency of secondary decay in teeth with failed sealants
Measured: 24 months after sealant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2019
- Study start17 Jun 2019
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caries,DentalStudies 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
- Model description
- Splith mouth design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 67 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Burlo Garofolo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Milena Cadenaro, DDS,MSc,PhD, Study chair, IRCCS Burlo GarofoloMaddalena Chermetz, DDS,MSc, Principal investigator, IRCCS Burlo Garofolo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04040920
- Sponsor's protocol ID
- RC 02/2019
- Status last verified
- May 2025
- First submitted
- 30 Jul 2019
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data collected during the study will be available from the Study Director on reasonable request after evaluation of a protocol approved by an Ethical Committee
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ozone Application Before Fissure Sealants: a Split Mouth Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04040920
- Acronym / sponsor ID
- RC 02/2019
- Conditions
- Caries,Dental
- Keywords
- Ozone, Pits and fissures sealants, Prevention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 67 participants (estimated)
- Lead sponsor
- IRCCS Burlo GarofoloUniversity, hospital or other
- Study start
- 17 Jun 2019 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 1 Aug 2019 (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.
Decay is a multifactorial infective degenerative disease of hard dental tissues, caused by Streptococcus mutans and Lactobacillus forming the bacterial biofilm of teeth surfaces. Decays generally evolve in fissures and pits of secondary molars. Pits and fissure sealants prevent decays if performed in two years from eruption. Ozone has bactericidal effect and remineralizing capacity on enamel.
The aim of this study is to assess the effectiveness of ozone application before sealants in increasing their duration in time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Splith mouth design
| Arm | Type | Receives |
|---|---|---|
| Ozone therapy | Experimental | Device: Ozone, Other: Pits and fissure sealantsOzone application before pits and fissure sealants |
| Pits and fissure sealants | Active comparator | Other: Pits and fissure sealants |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- first or second secondary molars to be sealed
- possibility to isolate with rubber dam both the teeth involved
- no clear signs of pigmentations
- good general health
Key exclusion criteria (6 listed)
- latex allergy
- epilepsy or other severe neurological pathologies
- psychiatric disease
- excessive sensibility to electrical current
- severe asthma
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 |
|---|---|---|
| OzoneOne minute of pretreatment with ozone by using the OzoneDTA device | Device | Ozone therapy |
| Pits and fissure sealantscleansing of the occlusal surfaces with a nylon brush and polishing toothpaste; surface etching with 36% orthophosphoric acid for 30'', surface cleaning and drying for 30 '', application of the sealing material, polymerization for 60''; | Other | Ozone therapy, Pits and fissure sealants |
Primary outcome
Sealants failure
Time frame: 12 months after sealant
Frequency of sealed failure defined as presence of to one or more of these outcomes: Marginal fissure; Sealant fracture; Decay; Marginal pigmentations; Sealant detachment Evaluation of the relative frequency of the different causes of failure
5 secondary outcomes
Sealants failure
Time frame: 6 months after sealant
Sealants failure
Time frame: 24 months after sealant
Secondary decay in failed sealants
Time frame: 6 months after sealant
Secondary decay in failed sealants
Time frame: 12 months after sealant
Secondary decay in failed sealants
Time frame: 24 months after sealant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Individual participant dataSharing planned: Yes. Data collected during the study will be available from the Study Director on reasonable request after evaluation of a protocol approved by an Ethical Committee
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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.
Milena Cadenaro, DDS,MSc,PhD study chair
IRCCS Burlo Garofolo
Maddalena Chermetz, DDS,MSc principal investigator
IRCCS Burlo Garofolo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ozone and Pits and fissure sealants in people with Caries,Dental, run by IRCCS Burlo Garofolo 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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 16 May 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Milena Cadenaro, DDS,MSc,PhD (+390403785358, milena.cadenaro@burlo.trieste.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sealants failure (time frame: 12 months after sealant). 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 May 2025.