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

NCT07671651 | Recruiting

• 1 other identifier: MUPEDDENTNSL-2
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dental Caries; Early Caries Lesion

Keywords

Ozone Therapy; Remineralization; Non-cavitated Caries Lesions; Pediatric Dentistry; Children; ROCS Medical Minerals; Early Caries Lesions

Outcome Measures

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.

  Baseline, Weeks 1, 2, 3, 4, and Week 8

Secondary Outcomes (2)

• Change in DIAGNOdent Pen laser fluorescence values of initial caries lesions

  Baseline, Weeks 1, 2, 3, 4, and Week 8

• Change in the clinical appearance of initial caries lesions assessed using standardized intraoral photographs

  Baseline, Weeks 1, 2, 3, 4, and Week 8

Study Arms (2)

Ozone Group

EXPERIMENTAL

Participants receive ozone therapy followed by ROCS Medical Minerals gel application for the management of initial caries lesions.

Device: Ozone Therapy; Other: other

Control Group

ACTIVE COMPARATOR

Participants receive ROCS Medical Minerals gel alone for the management of initial caries lesions.

Other: other

Interventions

Ozone Therapy DEVICE

Ozone therapy administered using the Ozonytron device for the treatment of initial caries lesions.

Ozone Group

other OTHER

ROCS Medical Minerals gel applied according to the manufacturer's instructions for remineralization of initial caries lesions.

Control Group; Ozone Group

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

Sponsors & Collaborators

• Neslihan Atmaca: lead

Study Sites (1)

Marmara Universty School of Dentistry

Istanbul, Maltepe, 34854, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Central Study Contacts

Neslihan Atmaca, Doctor of Dental Surgery

CONTACT

+905458314053; nsltmc@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: June 20, 2026
• First Posted: June 26, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): April 20, 2027
• Study Completion (Estimated): April 20, 2027
• Last Updated: June 30, 2026

Record last verified: 2026-06

Locations

TU (1)