A Two-year Study Evaluating the Surface-sealed Cervical Resin Composite Restorations in Comparison With the Non-sealed Restorations
Clinical Effectiveness of Using Surface Sealants on Cervical Resin Composite Restorations in Comparison With Non-sealed Restorations: A 2-year Randomized Clinical Trial
After finishing and polishing are completed, the tooth surface may exhibit microcracks and micro-irregularities that create a roughened surface, which may lead to plaque retention, gingival inflammation, and discoloration. The surface-penetrating sealant was introduced to fill micro-irregularities by capillary action, providing a uniform, regular surface and enhancing the surface smoothness. The application of unfilled low-viscosity surface sealants aims to enhance the luster, smoothness, and color stability of esthetic restorations and decrease stain absorption. They have low viscosity that enables them to easily spread and penetrate over these finished and polished surfaces, which may affect the life of the restoration positively. Additionally, it decreases surface porosity and creates a surface that is more thoroughly cured, improving the composite's stain resistance.
This prospective, parallel-group, randomized clinical study aims to compare the clinical effectiveness of using surface sealants on cervical resin composite restorations versus non-sealed restorations. Restorations will be assessed at baseline, 6, 12, 18, and 24 months using modified USPHS criteria. The primary outcome will be assessing marginal discoloration, and the secondary outcomes will be assessing color match, secondary caries, postoperative sensitivity, surface texture, and marginal adaptation. Color stability will be assessed by VITA Easyshade®.
調査の概要
状態
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：Nanees Ayman Hassan Aly
- 電話番号：01210974750
- メール：nanees.ayman@dentistry.cu.edu.eg
参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
Participant Inclusion Criteria:
- Adult patients aged 18-55 years.
- Patients with good oral hygiene (mild to moderate plaque accumulation).
- Patients with asymptomatic class V cavities in permanent teeth.
Teeth inclusion criteria:
- Vital posterior teeth with class V carious cavities.
- Moderate cavities (ICDAS 3 & 4).
- Free from signs and symptoms of irreversible pulpitis and pulpal necrosis.
- Teeth with no or grade 1 mobility.
Participant Exclusion Criteria:
- Patients who are unable to return for recall appointments.
- Patients with poor oral hygiene.
- Presence of abnormal oral, medical, or mental condition
- Presence of any parafunctional habits.
- Patients with TMJ problems.
Teeth Exclusion Criteria:
- Periodontal disease that may affect the prognosis of the restoration or the tooth itself.
- Fractured or visibly cracked teeth.
- Presence of any developmental or formative defects.
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：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Unfilled resin surface sealant group
Patients with carious cervical lesions (class V) in the esthetic zone receiving resin composite restorations covered by the Unfilled resin surface sealant
|
Unfilled resin surface sealant
|
|
実験的：Nano-filled resin surface sealant group
Patients with carious cervical lesions (class V) in the esthetic zone receiving resin composite restorations covered by the Nano-filled resin surface sealant
|
Unfilled resin surface sealant
|
|
アクティブコンパレータ：Class V Restorations without resin surface sealants.
Patients with carious cervical lesions (class V) in the esthetic zone receiving resin composite restorations not covered by the resin surface sealant
|
Restorations without resin surface sealants.
|
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 |
|---|---|---|
|
Marginal discoloration
時間枠：2 years
|
Modified USPHS criteria
|
2 years
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Color match, Secondary caries, Postoperative sensitivity, Surface texture , Marginal adaptation
時間枠：2 years
|
Modified USPHS criteria
|
2 years
|
|
Color stability
時間枠：2 years
|
by VITA Easyshade®
|
2 years
|
協力者と研究者
スポンサー
出版物と役立つリンク
一般刊行物
- • Amin, A. H., Yaakob, M. H., Nasir, W. Z. W., & Al-Kadhim, A. H. A. (2018). Evaluation the correlation between age, gender, and the incidence of cervical lesions. Journal of Clinical Research in Dentistry, 1(1). • Attia, R. M., Sobhy, E. M., & Abd El Hameed, M. E. S. (2023). Micro-Hardness and Surface Roughness of Bulk-Fill Composite Resin: Effect of Surface Sealant Application and Two Bleaching Regimens. European Journal of General Dentistry, 12(03), 169-176. • Calazans, F. S., Ferreira, T. D. M. J., Ñaupari-Villasante, R., Mendonça, R. P., Ornellas, G., Albuquerque, E. G., ... & Loguercio, A. D. (2024). Influence of surface sealants on the quality of posterior restorations with bulk-fill composites: A 4-year randomized clinical trial. Dental Materials, 40(3), 466-476. • Dawoud, B., Abou-Auf, E., & Shaalan, O. (2025). 24-Month clinical evaluation of cervical restorations bonded using radio-opaque universal adhesive compared to conventional universal adhesive in carious cervical lesions: A randomized clinical trial. Scientific Reports, 15(1), 5505. • Demarco, F. F., Collares, K., Coelho-de-Souza, F. H., Correa, M. B., Cenci, M. S., Moraes, R. R., & Opdam, N. J. (2015). Anterior composite restorations: A systematic review on long-term survival and reasons for failure. Dental materials, 31(10), 1214-1224. • de Melo Soares, V., de Oliveira Bomfim, H. L. Q., Romão, D. A., de Moraes Porto, I. C. C., & de Mendonça Fragoso, L. S. (2024). Comparative Analysis of Different Methods of Marginal Microleakage Evaluation for Restored Teeth by Composite Resin. Journal of Health Sciences, 26(4), 221-225. • Elwassefy, N., ElEmbaby, A., & Elkholany, N. (2023). Correlation between surface roughness and color stability of nano-and micro-hybrid resin composites using different surface treatment protocols. Egyptian Dental Journal, 69(1), 705-713.
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
追加の関連 MeSH 用語
その他の研究ID番号
- Surface sealants on composite
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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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PermaSeal™, Ultradent Products Inc., USAの臨床試験
-
University of California, San Diegoわからない