Clinical Outcomes, Cost-Effectiveness and Patient Satisfaction of Two Resin Infiltration Systems for The Management of White Spot Lesions
調査の概要
詳細な説明
White spot lesions (WSLs) are a common esthetic complication associated with orthodontic treatment and are characterized by subsurface enamel demineralization with preservation of the superficial enamel layer. These lesions may remain visible after orthodontic appliance removal and can negatively affect the patient's dental esthetics and satisfaction.
Resin infiltration is a minimally invasive treatment approach that aims to arrest the progression of early enamel caries and improve the optical appearance of WSLs. The infiltration of a low-viscosity resin into the porous enamel lesion modifies the refractive properties of the lesion and may reduce the visual contrast between the white spot lesion and the surrounding sound enamel.
This randomized controlled clinical trial will compare two resin infiltration systems, ICON and I-Mate, in the management of white spot lesions. Participants with eligible white spot lesions will be randomly allocated to receive treatment with either ICON resin infiltration or I-Mate resin infiltration according to the manufacturers' recommended clinical protocols.
The primary outcome of the study will be the clinical color matching of the treated white spot lesions with the adjacent natural tooth structure. Color matching will be evaluated using standardized clinical assessment criteria to determine the esthetic improvement achieved following resin infiltration treatment.
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：manar khaled, bachelor degree (BDS)
- 電話番号：01060631025
- メール：Manar_said@dentistry.cu.edu.eg
研究場所
-
-
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Cairo、エジプト
- Cairo Univesity
-
-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
健康ボランティアの受け入れ
説明
Inclusion Criteria:
Patients presenting with non-cavitated white spot lesions on anterior permanent teeth.
White spot lesions associated with previous orthodontic treatment. Lesions with intact surface enamel and no cavitation. Patients aged 16 to 35 years. Patients with good oral hygiene. Patients willing to participate in the study. Patients able to attend the scheduled follow-up visits. Patients who provide informed consent.
Exclusion Criteria:
Cavitated carious lesions. Spontaneous or elicited pain associated with the affected tooth. Tooth mobility. Signs or symptoms of pulpal or periapical pathology. Severe periodontal or oral conditions that may interfere with treatment or assessment.
Developmental enamel defects or other conditions that may interfere with assessment of white spot lesions.
Known allergy or sensitivity to any component of the materials used in the study.
Teeth with previous esthetic restorations or other treatments that may affect color assessment.
Patients unable to attend the scheduled follow-up visits. Poor oral hygiene that may interfere with treatment or assessment. Refusal to participate in the study.
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：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：ICON resin infiltration
ICON resin infiltration is a minimally invasive treatment for non-cavitated white spot lesions.
The lesion surface will be prepared according to the manufacturer's recommended clinical protocol, followed by application of ICON-Dry and ICON-Infiltrant to allow resin penetration into the porous enamel lesion.
The resin will then be light-cured according to the manufacturer's instructions, followed by finishing and polishing.
|
light cured low viscosity resin infiltration used to mask white spot lesion appearance
|
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実験的：IMATE resin infiltration
I-Mate resin infiltration will be applied for the management of non-cavitated white spot lesions according to the manufacturer's recommended clinical protocol.
The lesion will be appropriately prepared to facilitate resin penetration, followed by application and light-curing of the infiltrant according to the manufacturer's instructions.
Finishing and polishing will be performed after resin infiltration.
|
light cured low viscosity resin infiltration used to mask white spot lesion appearance
|
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 |
|---|---|---|
|
color matching of the treated white spot lesion with the adjacent natural tooth structure
時間枠：baseline , 3months , 6 months and 12 months
|
Color match of treated teeth will be assessed using the FDI World Dental Federation Esthetic Criteria. The color match will be evaluated using the FDI 5-point ordinal scale, and the mean color match score will be calculated for each treatment group. Measurement: Color match score Measurement tool: FDI World Dental Federation Esthetic Criteria Unit: FDI color match score |
baseline , 3months , 6 months and 12 months
|
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 (推定)
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
本研究に関する用語
キーワード
その他の研究ID番号
- 14422025471541
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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