Postoperative Bite Force After Bioflx and Zirconia Crowns in Children
16. september 2026 opdateret af: Shaimaa Shaban Mohamed El-desouky, Tanta University
Postoperative Bite Force in Children Following Full-Crown Restoration Under General Anesthesia: A Randomized Comparative Study of Bioflx and Zirconia Crowns
This randomized clinical trial aims to compare postoperative bite force following full-crown restoration with preformed Bioflx and zirconia crowns in children undergoing comprehensive dental treatment under general anesthesia.
Children aged 4-7 years requiring full-coverage restoration of primary molars will be randomly allocated to receive either Bioflx or zirconia crowns.
Occlusal bite force will be assessed before treatment and at predefined postoperative follow-up time points using a digital occlusal analysis system.
The study will evaluate changes in occlusal function following placement of the two types of pediatric full-coverage crowns.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This randomized clinical trial aims to compare postoperative occlusal bite force following full-crown restoration of primary molars with preformed Bioflx and zirconia crowns in children undergoing comprehensive dental treatment under general anesthesia. Children aged 4-7 years who require full-coverage crown restoration of primary molars will be randomly allocated to receive either a preformed Bioflx crown or a zirconia crown. The crowns will be fitted and cemented according to the respective manufacturers' recommendations, and the final occlusion will be evaluated following crown placement.
Occlusal bite force will be assessed before treatment and at predetermined postoperative follow-up time points using a digital occlusal analysis system. The study will compare changes in bite force following restoration with Bioflx and zirconia crowns to evaluate the recovery of occlusal function after comprehensive dental treatment under general anesthesia.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
30
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: shaimaa eldesouky, assistant professor
- Telefonnummer: 01008994242
- E-mail: shaimaaeldesouky@dent.tanta.edu.eg
Studiesteder
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-
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Tanta, Egypten
- faculty of dentistry, Tanta university
-
Kontakt:
- shaimaa eldesouky, assistant professor
- Telefonnummer: 01008994242
- E-mail: shaimaaeldesouky@dent.tanta.edu.eg
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- Children aged 4-7 years.
- Children requiring comprehensive dental treatment under general anesthesia.
- Children requiring full-coverage restoration of one or more primary molars with a preformed pediatric crown.
- Primary molars with sufficient remaining tooth structure to support full-crown restoration.
- Children with a generally healthy medical status and suitable for treatment under general anesthesia.
- Parents or legal guardians willing to provide written informed consent for participation in the study.
Exclusion Criteria:
- Children with systemic diseases or medical conditions that may affect oral health, occlusal function, or the ability to undergo general anesthesia.
- Children with craniofacial anomalies or developmental conditions that may significantly affect occlusion or bite force.
- Primary molars with inadequate remaining tooth structure for full-crown restoration.
- Teeth with advanced pathological root resorption or other conditions contraindicating crown restoration.
- Children with significant parafunctional habits, such as severe bruxism, that may affect bite-force measurements.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Bioflx Crown Group
Children in this group will receive full-crown restoration of indicated primary molars using preformed Bioflx pediatric crowns during comprehensive dental treatment under general anesthesia.
Occlusal bite force will be assessed before treatment and at the predefined postoperative follow-up time points using a digital occlusal analysis system.
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Preformed Bioflx pediatric crowns will be used for full-coverage restoration of indicated primary molars in children undergoing comprehensive dental treatment under general anesthesia.
|
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Aktiv komparator: Zirconia Crown Group
Children in this group will receive full-crown restoration of indicated primary molars using preformed zirconia pediatric crowns during comprehensive dental treatment under general anesthesia.
Occlusal bite force will be assessed before treatment and at the predefined postoperative follow-up time points using a digital occlusal analysis system.
|
Preformed zirconia pediatric crowns will be used for full-coverage restoration of indicated primary molars in children undergoing comprehensive dental treatment under general anesthesia.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Occlusal Bite Force
Tidsramme: Baseline (before crown placement), immediately after crown cementation, one and three months after treatment
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Change in occlusal bite force following full-crown restoration with preformed Bioflx or zirconia crowns, measured using a digital occlusal analysis system.
Bite force will be expressed as the percentage (%) of total occlusal force contributed by the treated/restored primary molar(s).
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Baseline (before crown placement), immediately after crown cementation, one and three months after treatment
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Occlusal Contacts
Tidsramme: Baseline, immediately after crown placement, and 1 and 3 month after treatment
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The number and distribution of occlusal contacts, including the presence or absence of premature occlusal contacts (number of patients/teeth with premature contacts), will be assessed using digital intraoral scanning and digital occlusal analysis
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Baseline, immediately after crown placement, and 1 and 3 month after treatment
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Abdelhafez A, Dhar V. Comparative clinical performance of stainless steel, zirconia, and Bioflx crowns in primary molars: a randomized controlled trial. BMC Oral Health. 2025 Apr 18;25(1):585. doi: 10.1186/s12903-025-05869-8.
- Singh T, Devashish, Kannan A, Chopra SS, Kaur R, Sethi T, Singh R. Bite Force Distribution and Occlusal Adjustment in Stainless Steel Crowns and BioFlx Crowns of Children Aged 4-8 Years. Int J Clin Pediatr Dent. 2026 Feb;19(2):145-149. doi: 10.5005/jp-journals-10005-3407. Epub 2026 Feb 12.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. oktober 2026
Primær færdiggørelse (Anslået)
1. december 2026
Studieafslutning (Anslået)
1. januar 2027
Datoer for studieregistrering
Først indsendt
13. september 2026
Først indsendt, der opfyldte QC-kriterier
13. september 2026
Først opslået (Faktiske)
17. september 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
18. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
16. september 2026
Sidst verificeret
1. september 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- #R-PED-7-25-3213
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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