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Clinical Performance of CAD/CAM Hard Hybrid Ceramic Inlays Versus Resin Composite Inlays in Vital Molars With Extensive Occluso-Proximal Cavities: Two-Year Randomized Clinical Trial

10. juni 2026 opdateret af: Sayed Ahmed Sayed Karim, Cairo University
this study aims to compare the clinical performance of hard hybrid ceramics and composite resin indirect restorations fabricated by CAD/CAM technology for the vital teeth with occluso-proximal cavities. the clinical performance assessed include marginal adaptation primarily and in addition to Color match, marginal discoloration, aesthetic anatomic form, recurrent caries and restoration fracture and post-operative hypersensitivity. the clinical performance will be assessed after the restoration cementation, after 6, 12, 18 and 24 months.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

A wide variety of materials is now available for the fabrication of indirect restorations used to manage extensive carious lesions, including high-strength ceramics, hybrid ceramics, and resin-composite blocks. Each material offers distinct advantages in strength, wear resistance, aesthetics, and bonding performance, thereby expanding treatment options for severely compromised posterior teeth. However, these differences in mechanical and optical behavior, marginal adaptation, and long-term durability under functional stresses complicate clinical material selection.

Limited data is available comparing the clinical performance of these materials, particularly in large cavities in these regions. More information is needed on how they prevent post-treatment sensitivity, maintain edge quality, and resist discoloration, wear, and fractures.

Though short-term studies indicate excellent survival rates and aesthetic results for CAD/CAM hybrid ceramic inlays (more than 90% survival after two years) (Coşkun, Aslan and Özkan, 2020; Hassan et al., 2024), and systematic reviews imply that CAD/CAM resin composite inlays match ceramic restorations (success rates ranging from 85.7% to 100% for composites versus 93.3% to 100% for ceramics) (Fathy et al., 2022; Tennert et al., 2024). There is a lack of direct clinical comparisons between these two material types in vital molars with occluso-proximal cavities. Much of the existing research is constrained to onlay designs or mixed-material groups, creating a significant gap in understanding which CAD/CAM block type delivers superior long-term performance for inlay restorations in vital teeth.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

50

Fase

  • Ikke anvendelig

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
  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Systematically healthy male or female subjects aged 16 to 50 years.
  • Patients with good oral hygiene.
  • Presence of a single vital molar with coronal destruction due to caries, defined as radiographic evidence of caries involving more than 50% of the total dentin thickness with loss of at least one proximal wall.
  • Cavitary preparation involving loss of at least one proximal walls (mesial and/or distal), with intact buccal and lingual walls, and all cavosurface margins located in enamel.
  • Presence of functional opposing teeth in stable occlusion

Exclusion Criteria:

  • Presence of systemic diseases (e.g., uncontrolled diabetes, immune disorders).
  • Current pregnancy or lactation.
  • Documented allergy to resin-based composites or adhesive systems.
  • Evidence of pulpal necrosis or previous endodontic treatment in the target tooth.
  • Presence of cracks or fractures involving the tooth structure.
  • Active localized or generalized periodontal disease.
  • Evidence of parafunctional habits, including bruxism or clenching.
  • High caries risk.

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: Hybrid ceramic group
indirect restoration (inlay design) using CAD/CAM Fabricated Hard Hybrid Ceramic blocks
Andet: hybrid ceramics
after caries removal, inlay cavity preparation and immediate dentin sealing, the cavities were scanned using intraoral scanner and the restoration designed and milled using Hard Hybrid Ceramic Blocks. the intaglio surface was air-abraded with 50 μm Al2O3 for 10-15 seconds. SHOFU HC Primer will be applied to the hybrid-ceramic group.
Aktiv komparator: Composite Resin group
indirect restoration (inlay design) using CAD/CAM Fabricated from Composite Resin Blocks
Andet: Composite resin
after caries removal, inlay cavity preparation and immediate dentin sealing, the cavities were scanned using intraoral scanner and the restoration designed and milled using Composite Resin Blocks. the intaglio surface was air-abraded with 50 μm Al2O3 for 10-15 seconds.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Marginal Adaptation
Tidsramme: baseline (after cementation), after 6 months, after 12 months, after 18 months and after 24 months.
measured using modified USPHS criteria
baseline (after cementation), after 6 months, after 12 months, after 18 months and after 24 months.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
color match
Tidsramme: baseline (after cementation), after 6 months, after 12 months, after 18 months and after 24 months.
measured using modified USPHS criteria
baseline (after cementation), after 6 months, after 12 months, after 18 months and after 24 months.
marginal discoloration
Tidsramme: baseline (after cementation), after 6 months, after 12 months, after 18 months and after 24 months.
measured using modified USPHS criteria
baseline (after cementation), after 6 months, after 12 months, after 18 months and after 24 months.
aesthetic anatomic form
Tidsramme: baseline (after cementation), after 6 months, after 12 months, after 18 months and after 24 months.
measured using modified USPHS criteria
baseline (after cementation), after 6 months, after 12 months, after 18 months and after 24 months.
recurrent caries
Tidsramme: baseline (after cementation), after 6 months, after 12 months, after 18 months and after 24 months.
measured using modified USPHS criteria
baseline (after cementation), after 6 months, after 12 months, after 18 months and after 24 months.
restoration fracture
Tidsramme: baseline (after cementation), after 6 months, after 12 months, after 18 months and after 24 months.
measured using modified USPHS criteria
baseline (after cementation), after 6 months, after 12 months, after 18 months and after 24 months.
Post-operative hypersensitivity
Tidsramme: baseline (after cementation), after 6 months, after 12 months, after 18 months and after 24 months.
measured using modified USPHS criteria
baseline (after cementation), after 6 months, after 12 months, after 18 months and after 24 months.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Cairo University

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. august 2026

Primær færdiggørelse (Anslået)

1. august 2028

Studieafslutning (Anslået)

1. november 2028

Datoer for studieregistrering

Først indsendt

10. juni 2026

Først indsendt, der opfyldte QC-kriterier

10. juni 2026

Først opslået (Faktiske)

15. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CairoU-Hybrid Ceramic Inlays

Plan for individuelle deltagerdata (IPD)

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