- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07575282
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.
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Huda Mohamed Elsayed Ahmed
- Telefonní číslo: 00201112099162
- E-mail: huda.elsayed@dentistry.cu.edu.eg
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Aktivní komparátor: 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.
|
|
Experimentální: 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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Clinical performance of the restoration by Modified US Public Health Service Criteria (USPHS).(Mechanical performance) (Anatomic contour).
Časové okno: 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)
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Clinical performance of the restoration by Modified US Public Health Service Criteria (USPHS). (Esthetic and sensitivity).
Časové okno: 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)
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Ředitel studie: Rania Sayed Mosallam, professor, Prof. Dr. Rania Sayed Mosallam
Publikace a užitečné odkazy
Obecné publikace
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- BFFCs in Class I cavities
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
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Klinické studie na Třída zubního kazu I
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Moataz Sleem Ahmed AliZatím nenabíráme