Bite Force Recovery Following Pediatric Full Crown Restorations
26. august 2026 opdateret af: Shaimaa Shaban Mohamed El-desouky, Tanta University
Bite Force Recovery Following Pediatric Full Crown Restorations: A Comparative Study of Bioflx and Stainless-steel Crowns
A component of masticatory function is bite force.
Dental caries is one factor that contributes to poor dental health, which has an overall negative influence on quality of life.
Caries has a detrimental after effect of functional impairment.
this study aims to evaluate how children occlusal bite forces are affected by complete dental care.
thirty children with dental caries in their primary molars, ages 5 to 8, of both sexes will be included.
Occlusal force gauge was used to measure the occlusal bite force in the vicinity of primary molars both before and after restorations.
A statistical analysis was performed on the collected data
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This controlled, randomized clinical trial aims to compare the recovery of occlusal function following restoration of primary molars with preformed BioFlx crowns and stainless steel crowns in children aged 5-8 years.
thirty eligible children requiring full-coverage crown restorations of primary molars will be randomly allocated to receive either a BioFlx crown or a stainless steel crown.
Occlusal bite force, occlusal contact distribution, vertical dimension, and masseter muscle activity assessed by surface electromyography will be evaluated before treatment, immediately after crown placement, and during follow-up.
Clinical evaluations will also be performed at 1and 3 months.
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
-
-
Cairo Governorate
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Tanta, Cairo Governorate, Egypten, 31527
- faculty of dentistry, Tanta university
-
Kontakt:
- shaimaa eldesouky
- 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 5-8 years.
- Healthy and cooperative children who are able to tolerate the required dental procedures and follow-up visits.
- Children requiring full-coverage crown restoration of a primary molar due to extensive or multisurface caries, wide proximal carious lesions
- Primary molars requiring pulp therapy followed by full-coverage restoration.
- Primary molars with more than one-third of the root structure remaining radiographically.
- Children with normal molar relationship.
- Children with normal overjet and overbite.
- Children without clinically evident malocclusion.
- Children without parafunctional oral habits.
Exclusion Criteria:
- Temporomandibular joint disorders
- Apparent facial asymmetry.
- Uncontrolled systemic disease or medical condition that may affect participation in the study or the dental treatment.
- Current or previous orthodontic treatment that may influence occlusion or bite-force measurements.
- Presence of parafunctional habits, such as bruxism or other abnormal occlusal habits.
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 |
|---|---|
|
Eksperimentel: BioFlx Crown Group
Participants will receive preformed BioFlx full-coverage crowns for restoration of eligible primary molars.
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Eligible primary molars will be restored with appropriately sized BioFlx crowns following tooth preparation according to the manufacturer's recommendations.
The crowns will be adjusted as needed, cemented using glass ionomer cement, and final occlusion will be verified.
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Aktiv komparator: Stainless Steel Crown Group
Participants will receive preformed stainless steel full-coverage crowns for restoration of eligible primary molars.
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Eligible primary molars will be prepared according to standard clinical procedures, fitted with an appropriately sized crown, adjusted and contoured as required, cemented using glass ionomer cement, and final occlusion will be verified.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Occlusal Bite Force Distribution
Tidsramme: Baseline (before crown placement), immediately after crown cementation, one and three months after treatment.
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The percentage of total occlusal force (%) distributed on the restored primary molar will be measured using a digital occlusal analysis system.
The closure demonstrating the maximum recorded occlusal force will be selected for analysis.
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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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Masseter Muscle Activity
Tidsramme: Baseline (before crown placement), immediately after crown cementation, one month and three months after treatment.
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Bilateral masseter muscle activity, expressed as integrated mean electromyographic activity (µV or µV·s, according to the recording output), will be measured using surface electromyography (sEMG) during the rest position and maximum voluntary clenching.
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Baseline (before crown placement), immediately after crown cementation, one month and three months after treatment.
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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
- Aishwarya N, Nagarathna C, Poovani S, Thumati P. Comparison of Bite Force and the Influencing Factors Pre- and Post-cementation of Stainless Steel Crown in Children Using T-Scan. Int J Clin Pediatr Dent. 2021 Jan-Feb;14(1):46-50. doi: 10.5005/jp-journals-10005-1900.
- Owais AI, Al-Battah AH, Abu Alhaija ES. Changes in occlusal bite force following placement of preformed metal crowns on primary molars in 4-6 years old children: a 6 months' follow-up pilot study. Eur Arch Paediatr Dent. 2019 Feb;20(1):9-14. doi: 10.1007/s40368-018-0370-8. Epub 2018 Nov 20.
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. september 2026
Primær færdiggørelse (Anslået)
1. november 2026
Studieafslutning (Anslået)
1. december 2026
Datoer for studieregistrering
Først indsendt
23. august 2026
Først indsendt, der opfyldte QC-kriterier
23. august 2026
Først opslået (Faktiske)
26. august 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
31. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
26. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- #R-PED-7-25-3210
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