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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Neslihan Atmaca, Doctor of Dental Surgery
- Telefoonnummer: +905458314053
- E-mail: nsltmc@gmail.com
Studie Locaties
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Maltepe
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Istanbul, Maltepe, Turkije (Türkiye), 34854
- Werving
- Marmara Universty School of Dentistry
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Contact:
- Neslihan Atmaca, Doctor of Dental Surgery
- Telefoonnummer: +905458314053
- E-mail: nsltmc@gmail.com
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
Accepteert gezonde vrijwilligers
Beschrijving
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Ozone Group
Participants receive ozone therapy followed by ROCS Medical Minerals gel application for the management of initial caries lesions.
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Ozone therapy administered using the Ozonytron device for the treatment of initial caries lesions.
ROCS Medical Minerals gel applied according to the manufacturer's instructions for remineralization of initial caries lesions.
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Actieve vergelijker: Control Group
Participants receive ROCS Medical Minerals gel alone for the management of initial caries lesions.
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ROCS Medical Minerals gel applied according to the manufacturer's instructions for remineralization of initial caries lesions.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in Quantitative Light-Induced Fluorescence (QLF) fluorescence loss (ΔF) values of initial caries lesions
Tijdsspanne: Baseline, Weeks 1, 2, 3, 4, and Week 8
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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.
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Baseline, Weeks 1, 2, 3, 4, and Week 8
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in DIAGNOdent Pen laser fluorescence values of initial caries lesions
Tijdsspanne: Baseline, Weeks 1, 2, 3, 4, and Week 8
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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.
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Baseline, Weeks 1, 2, 3, 4, and Week 8
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Change in the clinical appearance of initial caries lesions assessed using standardized intraoral photographs
Tijdsspanne: Baseline, Weeks 1, 2, 3, 4, and Week 8
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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.
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Baseline, Weeks 1, 2, 3, 4, and Week 8
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Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- MUPEDDENTNSL-2
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
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