Effect of Ozone Therapy on Remineralization of Initial Caries Lesions in Children

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.

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.