- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07672470
Parent Satisfaction With Zirconia, Bioflx, and 3D-Printed Crowns for Primary Molars
Modern Crown Options for Children: A Comparative Parent Satisfaction Study of Zirconia, Bioflx and 3D Printed Crown for Primary Molars.
This study will compare parent satisfaction with three different types of dental crowns used to restore primary (baby) molars in children: zirconia crowns, Bioflx crowns, and 3D-printed crowns.
Children between 3 and 7 years of age who need a full-coverage restoration of a primary molar will be invited to participate. Participants will be randomly assigned to receive one of the three crown types. All crowns will be placed by the same dentist using standardized treatment procedures.
After treatment, parents will be asked to complete a questionnaire about their satisfaction with the crown. The questionnaire will evaluate several aspects, including the crown's appearance, size, shape, color, durability, and overall satisfaction. Parent satisfaction will be assessed immediately after crown placement and again one month later.
The purpose of this study is to determine whether there are differences in parent satisfaction among these three crown options. The results may help dentists and families make informed decisions when choosing esthetic full-coverage restorations for primary teeth.
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
Dental caries remains one of the most common chronic diseases affecting children worldwide. When primary molars are extensively damaged by caries, full-coverage restorations are often indicated to restore function, maintain arch integrity, and preserve the tooth until its natural exfoliation. Traditionally, stainless steel crowns have been widely used for this purpose; however, increasing parental demand for esthetic restorations has led to the development and adoption of alternative crown materials.
Zirconia crowns have gained popularity because of their excellent esthetics, biocompatibility, and durability. Bioflx crowns have emerged as another esthetic option that offers flexibility and ease of placement. More recently, advances in digital dentistry and additive manufacturing have introduced 3D-printed crowns as a potential restorative solution, allowing for customized fabrication and improved esthetic outcomes.
Although these crown systems are increasingly utilized in pediatric dentistry, limited evidence is available regarding parental satisfaction with these treatment options. Parent perception plays an important role in treatment acceptance, adherence to dental recommendations, and overall evaluation of treatment success. Understanding parental preferences and satisfaction may assist clinicians in selecting restorative materials that meet both clinical requirements and family expectations.
This randomized clinical trial is designed to compare parent satisfaction among zirconia crowns, Bioflx crowns, and 3D-printed crowns used for the restoration of primary molars. Eligible children requiring full-coverage restoration of a primary molar will be randomly allocated to one of the three treatment groups. Crown placement procedures will be standardized and performed by the same operator to minimize variability.
Parent satisfaction will be assessed using a structured questionnaire evaluating crown shape, size, color, durability, and overall satisfaction. Assessments will be performed immediately after treatment and at one-month follow-up. The findings of this study may contribute to evidence-based decision making regarding esthetic full-coverage restorations in pediatric dentistry and provide information about factors influencing parental acceptance of different crown types.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Dakahlia Governorate
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Gamasa, Dakahlia Governorate, Egipt, 11152
- Delta University for Science and Technology
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
- Indication for full-coverage restoration. Cooperative behavior classified as positive or definitely positive according to the Frankl behavior rating scale.
Parent or legal guardian willing to provide informed consent and agree to random allocation to one of the study groups.
Child medically fit to receive routine dental treatment.
Exclusion Criteria:
- Children requiring advanced behavior management techniques such as sedation or general anesthesia.
Presence of significant systemic medical conditions that may affect oral health or treatment outcomes.
History of failed crown restoration on the same tooth. Teeth with extensive structural destruction that prevents placement of any of the study crown types.
Uncooperative behavior (Frankl negative or definitely negative).
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Inny
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: Zirconia Crown Group
Children receiving zirconia full-coverage crowns for primary molars
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Full-coverage prefabricated zirconia crown used for restoration of primary molars in children.
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Eksperymentalny: Bioflx Crown Group
Children receiving Bioflx full-coverage crowns for primary molars
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Flexible esthetic full-coverage crown used for restoration of primary molars in children.
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Eksperymentalny: 3D-Printed Crown Group
Children receiving 3D printed full-coverage crowns for primary molars
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Custom made full coverage crown fabricated using digital scanning and 3D printing technology for restoration of primary molars.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Parent Satisfaction Score
Ramy czasowe: Immediately after crown placement and at 1 month follow up
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Parent satisfaction with the pediatric crown restoration will be assessed using a structured 5-point Likert scale questionnaire. The questionnaire evaluates satisfaction with crown shape, size, color, durability, and overall appearance. Each item is scored as follows:
The primary outcome is the mean parent satisfaction score across the evaluated domains for each crown type (zirconia, Bioflx, and 3D-printed crowns). |
Immediately after crown placement and at 1 month follow up
|
Współpracownicy i badacze
Publikacje i pomocne linki
Publikacje ogólne
- Champagne C, Waggoner W, Ditmyer M, Casamassimo PS, MacLean J. Parental satisfaction with preveneered stainless steel crowns for primary anterior teeth. Pediatr Dent. 2007 Nov-Dec;29(6):465-9.
- Alazmah A. Evaluation of Parents and Child Satisfaction Toward Primary Molar Restoration with Preformed Metal Crowns and Its Impact on Child Bullying. Healthcare (Basel). 2025 Dec 26;14(1):62. doi: 10.3390/healthcare14010062.
- Almaghrabi MA, Albadawi EA, Dahlan MA, Aljohani HR, Ahmed NM, Showlag RA. Exploring Parent's Satisfaction and the Effectiveness of Preformed Metal Crowns Fitting by Hall Technique for Carious Primary Molars in Jeddah Region, Saudi Arabia: Findings of a Prospective Cohort Study. Patient Prefer Adherence. 2022 Sep 8;16:2497-2507. doi: 10.2147/PPA.S370159. eCollection 2022.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- 026032213
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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