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The Impact of Adhesion Strategy on the Clinical Performance Of Indirect Dental Restorations

8. juni 2026 oppdatert av: Malmö University

The Influence of Cement Systems on the Outcome of Tooth Supported Zirconia Crowns in the Posterior Region: a Randomized ,Multicenter, and Practice-based Clinical Trial

The goal of this clinical trial is to evaluate whether different cement systems influence the clinical outcome of posterior tooth supported zirconia crowns in adult patients requiring single crown restorations. The main questions it aims to answer are:

  • Do glass ionomer cements provide clinical outcomes comparable to those of resin cements for posterior zirconia crowns?
  • Do marginal discoloration, marginal integrity, and biological complications differ between the cement systems?
  • Do patient reported and clinician reported outcomes differ between the cementation procedures?

Researchers will compare zirconia crowns cemented with either a glass ionomer cement or a resin cement to evaluate differences in clinical outcomes.

Participants will:

  • Receive posterior zirconia crowns fabricated according to standardized clinical procedures
  • Be randomized to cementation with either a glass ionomer cement or a resin cement
  • Undergo clinical examinations assessing crown survival, marginal adaptation, discoloration, caries, periodontal status, and wear
  • Complete questionnaires regarding patient comfort and treatment experience
  • Attend baseline and annual follow-up examinations for up to 10 years

Studieoversikt

Status

Påmelding etter invitasjon

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Tooth damage has significant impact on a person's quality of life and damaged teeth should be treated to restore lost functions and prevent further damage. Loss of tooth substance can be restored by a direct (filling) or indirect restoration (artificial crown). These interventions differ in some operative aspects but share key challenges, particularly in achieving optimal adhesion to tooth substance to secure predictable retention and the integrity of the marginal seal.

Failure of the adhesive interface is a major determinant of restoration longevity and may manifest across patient-centered, biological, and technical outcomes.

Marginal degradation may result in discoloration, representing an early clinical indicator of interface breakdown that negatively affects patient satisfaction and may lead to a need for retreatment. Progressive marginal leakage facilitates bacterial access, increasing the risk of biological complications such as secondary caries and pulpal involvement.

Loss of retention represents a major technical complication, often requiring replacement of the restoration and contributing to cumulative loss of tooth structure over time.

Despite advances in restorative materials and adhesive systems, clinical outcomes remain variable, and the relative contribution of material properties, procedural complexity, and biological factors to long-term failure is not fully understood. In particular, the role of technique sensitivity and procedural complexity as independent determinants of restoration survival remains insufficiently characterized. Improved understanding of these interacting factors will enable more precise selection of restorative materials and cementation strategies.

This project will: (a) identify and quantify clinically relevant determinants of restoration failure, enabling improved prediction of restoration survival and patient satisfaction, (b) elucidate how interfacial degradation and technique sensitivity contribute to biological and technical complications, (c) aid clinical decision-making by guiding selection of materials and procedures based on their performance and complexity.

Studietype

Intervensjonell

Registrering (Antatt)

110

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Sverige
    • Skåne County
      • Hörby, Skåne County, Sverige
        • Sandin Dentalklinik
      • Malmö, Skåne County, Sverige, 21118
        • Tandläkare Le

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • Need of one single crown on vital posterior tooth
  • Speak and understand Swedish language
  • Free from dental/oral disease; caries, periodontal disease

Exclusion Criteria:

  • Only individuals who do not meet the inclusion criteria will be excluded.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Resin cement
Tooth-supported zirconia crowns cemented with a resin-based cement
Annen: Resin cement
Zirconia crowns cemented with resin cement
Aktiv komparator: Glass-ionomer cement
Tooth-supported zirconia crowns cemented with a glass-ionomer cement
Annen: Glass-ionomer cement
Zirconia crowns cemented with glass-ionomer cement

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Clinical outcome of tooth-supported zirconia crowns from baseline to 1-year follow up
Tidsramme: Baseline and 1 year.
Clinical performance of tooth supported zirconia crowns assessed using modified CDA criteria, including survival, success, biological complications, technical complications, marginal integrity, discoloration, and surface morphology.
Baseline and 1 year.
Clinical outcome of tooth-supported zirconia crowns from baseline to 3-year follow up
Tidsramme: Baseline and 3 years.
Clinical performance of tooth supported zirconia crowns assessed using modified CDA criteria, including survival, success, biological complications, technical complications, marginal integrity, discoloration, and surface morphology.
Baseline and 3 years.
Clinical outcome of tooth-supported zirconia crowns from baseline to 5-year follow up
Tidsramme: Baseline and 5 years.
Clinical performance of tooth supported zirconia crowns assessed using modified CDA criteria, including survival, success, biological complications, technical complications, marginal integrity, discoloration, and surface morphology.
Baseline and 5 years.
Clinical outcome of tooth-supported zirconia crowns from baseline to 10-year follow up
Tidsramme: Baseline and 10 years.
Clinical performance of tooth supported zirconia crowns assessed using modified CDA criteria, including survival, success, biological complications, technical complications, marginal integrity, discoloration, and surface morphology.
Baseline and 10 years.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change from Baseline in "Patient-reported Outcome Measurement" at 1 year
Tidsramme: Baseline and 1 year.
Patient reported and operator reported outcomes will be assessed using structured questionnaires evaluating treatment comfort, clinical handling, and overall satisfaction. Questionnaire scores range from 1 to 5, where higher scores indicate greater satisfaction and improved treatment experience.
Baseline and 1 year.
Change from Baseline in "Patient-reported Outcome Measurement" at 3 year
Tidsramme: Baseline and 3 year.
Patient reported and operator reported outcomes will be assessed using structured questionnaires evaluating treatment comfort, clinical handling, and overall satisfaction. Questionnaire scores range from 1 to 5, where higher scores indicate greater satisfaction and improved treatment experience.
Baseline and 3 year.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Malmö University

Etterforskere

  • Hovedetterforsker: Christel Larsson, Ph.D., Malmö University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. juni 2026

Primær fullføring (Antatt)

1. juli 2028

Studiet fullført (Antatt)

1. juni 2036

Datoer for studieregistrering

Først innsendt

3. juni 2026

Først innsendt som oppfylte QC-kriteriene

8. juni 2026

Først lagt ut (Faktiske)

12. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

12. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2026-03170-01

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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