Clinical Evaluation of Bulk-Fill Flowable Composite Versus Submicron Hybrid Composite in Class I Carious Cavities.
Clinical Evaluation of Bulk-Fill Flowable Resin-Based Composite Versus Submicron Hybrid Resin-Based Composite in Class I Carious Cavities Over 18-Month: Randomized Controlled Trial.
調査の概要
状態
条件
詳細な説明
Resin-based composites are now the preferred material for posterior tooth restoration Silva et al.,2023. To combat the polymerization shrinkage of resin-based composites, an incremental method for placing composite resin was created. Nevertheless, this method takes a lot of time and could cause air to become trapped between successive composite resin layers. Some structural and chemical modifications to the composite resin composition have been suggested in an attempt to lessen the undesirable consequences of the composites, such as the tension produced on the tooth or restoration interface Arbildo-Vega et al.,2020.
Newer resin formulations that combine small particles (0.1 μm-1.0 μm) and submicron particles (0.04 μm) with larger filler loading percentages are referred to as submicron hybrid composites. They exhibit enhanced polishability and gloss retention, as well as greater mechanical and physical properties Vishwanath et al.,2021.
Bulk-fill resin-based composites (BF-RBCs) were introduced to the dental market in the past decade to address challenges related to the incremental placement of conventional resin-based composites in posterior teeth. Originally, the term "bulk-fill" referred to resin composites that could be used in increments of 4-5mm, making them suitable for both full-body and base bulk-fill techniques. Current commercial bulk-fill resin-based composites (BF-RBCs) can be categorized based on their viscosity into flowable (low viscosity) and sculptable (high viscosity) types. In the past, flowable bulk-fill RBCs were known to have lower mechanical properties compared to high-viscosity RBCs. However, the addition of nanofillers in the latest generation of flowable BF-RBCs has improved their mechanical properties while preserving their low viscosity Gatica et al.,2023.
For the majority of commercially available flowable BF-RBCs, the manufacturer advises applying a top layer of conventional resin composite over the restoration. This makes it possible to partially offset its decreased flexural strength and prevent the restoration from wearing out too quickly Gatica et al.,2023. However according to the manufacturer's instructions for (Brilliant Bulk-Fill Flow, Coltene/Whaledent) it can be used for fillings in the posterior region even without an additional covering layer. It is composed of pre-polymerized fillers that include dental glass with nanosilica particles and silanized fillers to enhance bonding strength within the resin matrix, along with larger dental glass fillers to minimize polymerization shrinkage.
This project will be designed to test the null hypothesis that bulk-fill flowable resin-based composite will have the same clinical performance as the submicron hybrid resin-based composite in restoring class I carious cavities according to the Modified United State Public Health Service (USPHS) criteria.
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:Huda Mohamed Elsayed Ahmed
- 電話番号:00201112099162
- メール:huda.elsayed@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
Inclusion Criteria:
- Co-operative patients approving to participate in the trial
- Simple class I carious lesion scored based on the International Caries Detection and Assessment System (ICDAS) is code 2 or 3
- Vital upper or lower molar
- Presence of favorable occlusion.
- Presence of opposing teeth.
- Proper teeth aligment.
Exclusion Criteria:
- Patients with poor oral hygiene
- Bruxism or occlusion abnormalities.
- Allergic reaction to the materials used.
- Disabilities
- Pregnancy
- Heavy smoking
- Xerostomia
- Lack of Compliance
- TMJ disorders
- Unwillingness or inability to attend follow-ups.
- Deep caries close to pulp.
- Teeth with signs/symptoms of irreversible pulpitis or necrosis.
- Endodontically treated teeth.
- Extensive occlusal destruction
- Periodontal affection
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 |
|---|---|
|
アクティブコンパレータ:control group
patients with simple class I cavities to be restored with Submicron hybrid resin- based composite.
|
Patients with simple class I cavities to be restored with Submicron hybrid resin- based composite.
|
|
実験的:Intervention group
patients with simple class I cavities to be restored with Bulk-fill flowable resin-based composite.
|
patients with simple class I cavities to be restored with Bulk-fill flowable resin-based composite.
|
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 |
|---|---|---|
|
Clinical performance of the restoration by Modified US Public Health Service Criteria (USPHS).(Mechanical performance) (Anatomic contour).
時間枠:18 months (baseline,6,12,18 months)
|
The scoring will be: Alpha (means ideal), Bravo (means acceptable), Charlie (means unacceptable) and Delta (means severe failure).
|
18 months (baseline,6,12,18 months)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Clinical performance of the restoration by Modified US Public Health Service Criteria (USPHS). (Esthetic and sensitivity).
時間枠:18 months (baseline,6,12,18 month)
|
The scoring will be: Alpha (means ideal), Bravo (means acceptable), Charlie (means unacceptable) and Delta (means severe failure).
|
18 months (baseline,6,12,18 month)
|
協力者と研究者
スポンサー
捜査官
- スタディディレクター:Rania Sayed Mosallam, professor、Prof. Dr. Rania Sayed Mosallam
出版物と役立つリンク
一般刊行物
- Bayne SC, Schmalz G. Reprinting the classic article on USPHS evaluation methods for measuring the clinical research performance of restorative materials. Clin Oral Investig. 2005 Dec;9(4):209-14. doi: 10.1007/s00784-005-0017-0. No abstract available.
- Tyas MJ. Clinical evaluation of glass-ionomer cement restorations. J Appl Oral Sci. 2006;14 Suppl:10-3. doi: 10.1590/s1678-77572006000700003.
- Hickel R, Roulet JF, Bayne S, Heintze SD, Mjor IA, Peters M, Rousson V, Randall R, Schmalz G, Tyas M, Vanherle G. Recommendations for conducting controlled clinical studies of dental restorative materials. Clin Oral Investig. 2007 Mar;11(1):5-33. doi: 10.1007/s00784-006-0095-7. Epub 2007 Jan 30.
- Arbildo-Vega HI, Lapinska B, Panda S, Lamas-Lara C, Khan AS, Lukomska-Szymanska M. Clinical Effectiveness of Bulk-Fill and Conventional Resin Composite Restorations: Systematic Review and Meta-Analysis. Polymers (Basel). 2020 Aug 10;12(8):1786. doi: 10.3390/polym12081786.
- Atreja A, Bellam N, Levy SR. Strategies to enhance patient adherence: making it simple. MedGenMed. 2005 Mar 16;7(1):4.
- Vishwanath, V., Rao, M.H. and Prasad, B.K., 2021. Clinical performance of a direct submicron hybrid and indirect zirconium reinforced composite restorations: A 2-year assessment. SRM Journal of Research in Dental Sciences, 12(2), pp.79 85.
- Silva G, Marto CM, Amaro I, Coelho A, Sousa J, Ferreira MM, Francisco I, Vale F, Oliveiros B, Carrilho E, Paula AB. Bulk-Fill Resins versus Conventional Resins: An Umbrella Review. Polymers (Basel). 2023 Jun 8;15(12):2613. doi: 10.3390/polym15122613.
- Parra Gatica E, Duran Ojeda G, Wendler M. Contemporary flowable bulk-fill resin-based composites: a systematic review. Biomater Investig Dent. 2023 Feb 22;10(1):8-19. doi: 10.1080/26415275.2023.2175685. eCollection 2023.
- Canali GD, Ignacio SA, Rached RN, Souza EM. One-year clinical evaluation of bulk-fill flowable vs. regular nanofilled composite in non-carious cervical lesions. Clin Oral Investig. 2019 Feb;23(2):889-897. doi: 10.1007/s00784-018-2509-8. Epub 2018 Jun 12.
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
その他の研究ID番号
- BFFCs in Class I cavities
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?
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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う蝕クラスⅠの臨床試験
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Jiangxi Provincial Cancer HospitalLin Zhou; Zhijun Chen; Yu Su; Jingxiu Zhong; Tianzhu Lu積極的、募集していない
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University of NebraskaBristol-Myers Squibb利用できない
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University Hospital, Basel, Switzerland完了
-
AbbVie募集
Submicron hybrid resin- based composite.の臨床試験
-
Rawda Hesham Abd ElAziz募集