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Recruiting
NCT07671651
Effect of Ozone Therapy on Remineralization of Initial Caries Lesions in Children
Conditions: Dental Caries, Early Caries Lesion
Sex: All
Ages: 6 Years – 14 Years
Healthy volunteers: No
Phase: NA
Enrollment: 80
Sponsor: Neslihan Atmaca
Location: Marmara Universty School of Dentistry Istanbul Maltepe
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.
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
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.
Source: ClinicalTrials.gov (NCT07671651). StuddyBuddy aggregates publicly available trial information.