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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Neslihan Atmaca, Doctor of Dental Surgery
- 電話番号：+905458314053
- メール：nsltmc@gmail.com
研究場所
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Maltepe
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Istanbul、Maltepe、トルコ（Türkiye）、34854
- 募集
- Marmara Universty School of Dentistry
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コンタクト：
- Neslihan Atmaca, Doctor of Dental Surgery
- 電話番号：+905458314053
- メール：nsltmc@gmail.com
-
-
参加基準
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
説明
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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アクティブコンパレータ：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Quantitative Light-Induced Fluorescence (QLF) fluorescence loss (ΔF) values of initial caries lesions
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in DIAGNOdent Pen laser fluorescence values of initial caries lesions
時間枠：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
時間枠：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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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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