Dental CariesOZONE-CARIESNCT07671651
Effect of Ozone Therapy on Remineralization of Initial Caries Lesions in Children
A study testing Ozone Therapy and other in people with Dental Caries and Early Caries Lesion, run by Neslihan Atmaca at 1 site in Turkey (Türkiye).
Trial summary
Initial caries lesions can be managed using non-invasive treatment approaches that promote remineralization and prevent lesion progression. Ozone therapy has been suggested as an adjunctive treatment because of its antimicrobial properties and its potential to enhance remineralization. Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Dental Caries, Early Caries Lesion
- What is being tested?
- Ozone Therapy and other
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2026to 20 Apr 2027
- 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 14 years
- All sexes
- No healthy volunteers
- Child
Inclusion Criteria Children aged 6-12 years. Presence of at least one initial non-cavitated caries lesion. Systemically healthy children. Frankl Behavior Rating Scale score of 3 or 4. Written informed consent obtained from the parent or legal guardian. Exclusion Criteria Cavitated caries lesions requiring restorative treatment. History of allergy to any study material. Systemic diseases affecting oral health or salivary flow. Respiratory diseases (e.g., asthma) contraindicating ozone therapy. Use of medications affecting salivary flow or enamel remineralization. Uncooperative children (Frankl score 1 or 2). Parent or guardian unwilling to participate or unable to attend follow-up visits.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Marmara Universty School of Dentistry
Istanbul, Maltepe, 34854
Neslihan Atmaca, Doctor of Dental Surgery, +905458314053, nsltmc@gmail.com
About this study
Official title: Effect of Ozone Therapy on the Remineralization of Initial Caries Lesions in Children: A Randomized Controlled Clinical Trial
Initial caries lesions can be managed using non-invasive treatment approaches that promote remineralization and prevent lesion progression. Ozone therapy has been suggested as an adjunctive treatment because of its antimicrobial properties and its potential to enhance remineralization.
This randomized controlled clinical trial aims to evaluate the effect of ozone therapy on the remineralization of initial caries lesions in children. Participants will be randomly assigned to receive either ozone therapy followed by application of a remineralizing gel or application of the remineralizing gel alone.
Changes in lesion status will be assessed over time using clinical and optical evaluation methods. The results of this study may contribute to the development of evidence-based minimally invasive approaches for the management of early caries lesions in pediatric patients.
Read the detailed description
Dental caries remains one of the most common chronic diseases affecting children worldwide. Initial non-cavitated caries lesions represent a reversible stage of the disease and provide an opportunity for non-invasive treatment through remineralization strategies.
Ozone therapy has attracted interest in pediatric dentistry because of its antimicrobial effects and its potential to improve conditions for remineralization. However, evidence regarding its clinical effectiveness as an adjunct to remineralizing agents remains limited.
The aim of this prospective randomized controlled clinical trial is to evaluate the effectiveness of ozone therapy in the management of initial caries lesions in children.
Eligible participants with initial non-cavitated caries lesions will be randomly allocated to one of two study groups. The intervention group will receive ozone therapy followed by application of ROCS Medical Minerals remineralizing gel, while the control group will receive ROCS Medical Minerals remineralizing gel alone.
Participants will be evaluated at baseline and during follow-up visits according to the study protocol. Changes in lesion characteristics and remineralization outcomes will be monitored using clinical and optical assessment methods.
The primary objective of the study is to determine whether adjunctive ozone therapy provides additional benefit in promoting remineralization compared with remineralizing gel alone. The findings may provide further evidence regarding minimally invasive management of early caries lesions in children.
- Conditions
- Dental Caries, Early Caries Lesion
- Being tested
- Ozone Therapy, other
- Keywords
- Ozone Therapy, Remineralization, Non-cavitated Caries Lesions, Pediatric Dentistry, Children, ROCS Medical Minerals, Early Caries Lesions
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ozone TherapyDevice
Ozone therapy administered using the Ozonytron device for the treatment of initial caries lesions.
otherOther
ROCS Medical Minerals gel applied according to the manufacturer's instructions for remineralization of initial caries lesions.
| Study group | Role | What they receive |
|---|---|---|
| Ozone Group | Experimental | Participants receive ozone therapy followed by ROCS Medical Minerals gel application for the management of initial caries lesions. Receives: Device: Ozone Therapy; Other: other |
| Control Group | Active comparator | Participants receive ROCS Medical Minerals gel alone for the management of initial caries lesions. Receives: Other: other |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Quantitative Light-Induced Fluorescence (QLF) fluorescence loss (ΔF) values of initial caries lesions
Fluorescence loss (ΔF) values of each initial caries lesion will be assessed using the QrayCam Pro system at baseline and follow-up visits (Weeks 1, 2, 3, 4, and 8). The outcome will be reported as the change in ΔF values from baseline to each follow-up visit. Lower ΔF values indicate greater remineralization, reflecting reduced mineral loss.
Measured: Baseline, Weeks 1, 2, 3, 4, and Week 8
Secondary outcomes (2)
Change in DIAGNOdent Pen laser fluorescence values of initial caries lesions
Laser fluorescence values of each initial caries lesion will be assessed using the DIAGNOdent Pen at baseline and follow-up visits (Weeks 1, 2, 3, 4, and 8). The outcome will be reported as the change in DIAGNOdent Pen values from baseline to each follow-up visit. Lower DIAGNOdent values indicate reduced lesion severity and improved lesion status.
Measured: Baseline, Weeks 1, 2, 3, 4, and Week 8
Change in the clinical appearance of initial caries lesions assessed using standardized intraoral photographs
The clinical appearance of each initial caries lesion will be assessed using standardized intraoral photographs obtained at baseline and follow-up visits (Weeks 1, 2, 3, 4, and 8). The outcome will be reported as changes in lesion appearance from baseline to each follow-up visit using predefined clinical evaluation criteria.
Measured: Baseline, Weeks 1, 2, 3, 4, and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study start1 Jun 2026
- Primary completion20 Apr 2027 (estimated)
- Study completion20 Apr 2027 (estimated)
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
- Model description
- Participants will be randomly assigned to one of two parallel groups. The intervention group will receive ozone therapy followed by ROCS Medical Minerals gel application, while the control group will receive ROCS Medical Minerals gel alone.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neslihan Atmaca
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Neslihan Atmaca, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07671651
- Sponsor's protocol ID
- MUPEDDENTNSL-2
- Acronym
- OZONE-CARIES
- Status last verified
- Jun 2026
- First submitted
- 20 Jun 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ozone Therapy on the Remineralization of Initial Caries Lesions in Children: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07671651
- Acronym / sponsor ID
- OZONE-CARIES / MUPEDDENTNSL-2
- Conditions
- Dental Caries, Early Caries Lesion
- Keywords
- Ozone Therapy, Remineralization, Non-cavitated Caries Lesions, Pediatric Dentistry, Children, ROCS Medical Minerals, Early Caries Lesions
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Neslihan AtmacaUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 20 Apr 2027 (estimated)
- Study completion
- 20 Apr 2027 (estimated)
- First posted
- 26 Jun 2026 (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.
Initial caries lesions can be managed using non-invasive treatment approaches that promote remineralization and prevent lesion progression. Ozone therapy has been suggested as an adjunctive treatment because of its antimicrobial properties and its potential to enhance remineralization.
This randomized controlled clinical trial aims to evaluate the effect of ozone therapy on the remineralization of initial caries lesions in children. Participants will be randomly assigned to receive either ozone therapy followed by application of a remineralizing gel or application of the remineralizing gel alone.
Changes in lesion status will be assessed over time using clinical and optical evaluation methods. The results of this study may contribute to the development of evidence-based minimally invasive approaches for the management of early caries lesions in pediatric patients.
Detailed description
Dental caries remains one of the most common chronic diseases affecting children worldwide. Initial non-cavitated caries lesions represent a reversible stage of the disease and provide an opportunity for non-invasive treatment through remineralization strategies.
Ozone therapy has attracted interest in pediatric dentistry because of its antimicrobial effects and its potential to improve conditions for remineralization. However, evidence regarding its clinical effectiveness as an adjunct to remineralizing agents remains limited.
The aim of this prospective randomized controlled clinical trial is to evaluate the effectiveness of ozone therapy in the management of initial caries lesions in children.
Eligible participants with initial non-cavitated caries lesions will be randomly allocated to one of two study groups. The intervention group will receive ozone therapy followed by application of ROCS Medical Minerals remineralizing gel, while the control group will receive ROCS Medical Minerals remineralizing gel alone.
Participants will be evaluated at baseline and during follow-up visits according to the study protocol. Changes in lesion characteristics and remineralization outcomes will be monitored using clinical and optical assessment methods.
The primary objective of the study is to determine whether adjunctive ozone therapy provides additional benefit in promoting remineralization compared with remineralizing gel alone. The findings may provide further evidence regarding minimally invasive management of early caries lesions in children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two parallel groups. The intervention group will receive ozone therapy followed by ROCS Medical Minerals gel application, while the control group will receive ROCS Medical Minerals gel alone.
| Arm | Type | Receives |
|---|---|---|
| Ozone Group | Experimental | Device: Ozone Therapy, Other: otherParticipants receive ozone therapy followed by ROCS Medical Minerals gel application for the management of initial caries lesions. |
| Control Group | Active comparator | Other: otherParticipants receive ROCS Medical Minerals gel alone for the management of initial caries lesions. |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
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 |
|---|---|---|
| Ozone TherapyOzone therapy administered using the Ozonytron device for the treatment of initial caries lesions. | Device | Ozone Group |
| otherROCS Medical Minerals gel applied according to the manufacturer's instructions for remineralization of initial caries lesions. | Other | Control Group, Ozone Group |
Primary outcome
Change in Quantitative Light-Induced Fluorescence (QLF) fluorescence loss (ΔF) values of initial caries lesions
Time frame: Baseline, Weeks 1, 2, 3, 4, and Week 8
Fluorescence loss (ΔF) values of each initial caries lesion will be assessed using the QrayCam Pro system at baseline and follow-up visits (Weeks 1, 2, 3, 4, and 8). The outcome will be reported as the change in ΔF values from baseline to each follow-up visit. Lower ΔF values indicate greater remineralization, reflecting reduced mineral loss.
2 secondary outcomes
Change in DIAGNOdent Pen laser fluorescence values of initial caries lesions
Time frame: Baseline, Weeks 1, 2, 3, 4, and Week 8
Change in the clinical appearance of initial caries lesions assessed using standardized intraoral photographs
Time frame: Baseline, Weeks 1, 2, 3, 4, and Week 8
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 30 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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.
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 Therapy and other in people with Dental Caries and Early Caries Lesion, run by Neslihan Atmaca at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 30 Jun 2026. 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 Turkey (Türkiye). 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 Neslihan Atmaca, Doctor of Dental Surgery (+905458314053, nsltmc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Quantitative Light-Induced Fluorescence (QLF) fluorescence loss (ΔF) values of initial caries lesions (time frame: Baseline, Weeks 1, 2, 3, 4, and Week 8). 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 30 Jun 2026.