Effect of Ozone Therapy on Remineralization of Initial Caries Lesions in Children
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-14
SponsorNeslihan Atmaca
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Ozone Therapy
DeviceOzone therapy administered using the Ozonytron device for the treatment of initial caries lesions.
other
Other interventionROCS Medical Minerals gel applied according to the manufacturer's instructions for remineralization of initial caries lesions.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Ozone GroupExperimental treatment 2 interventions
Group B: Control GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline, Weeks 1, 2, 3, 4, and Week 8Secondary outcomes
1
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.
Time frame
Baseline, Weeks 1, 2, 3, 4, and Week 82
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.
Time frame
Baseline, Weeks 1, 2, 3, 4, and Week 8Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Neslihan Atmaca
Lead sponsor
Marmara University
Sponsor institution
Source ClinicalTrials.gov