Effect of Ozone Therapy on Remineralization of Initial Caries Lesions in Children (OZONE-CARIES)

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.

Study Overview

• Status: Recruiting
• Conditions: Dental Caries; Early Caries Lesion
• Intervention / Treatment: Device: Ozone Therapy; Other: other

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 Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Neslihan Atmaca, Doctor of Dental Surgery; Phone Number: +905458314053; Email: nsltmc@gmail.com

Study Locations

• Turkey (Türkiye)
  • Maltepe
    • Istanbul, Maltepe, Turkey (Türkiye), 34854
      • Recruiting
      • Marmara Universty School of Dentistry
      • Contact: Neslihan Atmaca, Doctor of Dental Surgery; Phone Number: +905458314053; Email: nsltmc@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ozone Group; Participants receive ozone therapy followed by ROCS Medical Minerals gel application for the management of initial caries lesions.	Device: Ozone Therapy; Ozone therapy administered using the Ozonytron device for the treatment of initial caries lesions.; Other: other; ROCS Medical Minerals gel applied according to the manufacturer's instructions for remineralization of initial caries lesions.
Active Comparator: Control Group; Participants receive ROCS Medical Minerals gel alone for the management of initial caries lesions.	Other: other; ROCS Medical Minerals gel applied according to the manufacturer's instructions for remineralization of initial caries lesions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Weeks 1, 2, 3, 4, and Week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Baseline, Weeks 1, 2, 3, 4, and Week 8

Collaborators and Investigators

• Sponsor: Neslihan Atmaca

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2026
• Primary Completion (Estimated): April 20, 2027
• Study Completion (Estimated): April 20, 2027

Study Registration Dates

• First Submitted: June 20, 2026
• First Submitted That Met QC Criteria: June 25, 2026
• First Posted (Actual): June 26, 2026

Study Record Updates

• Last Update Posted (Actual): June 30, 2026
• Last Update Submitted That Met QC Criteria: June 26, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Children; Pediatric Dentistry; Remineralization; Ozone Therapy; Early Caries Lesions; Non-cavitated Caries Lesions; ROCS Medical Minerals
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth Demineralization; Dental Caries
• Other Study ID Numbers: MUPEDDENTNSL-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No