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Microbial Adhesion and Peri-Implant Tissue Health in All-on-Four Hybrid Prostheses Supported by Zantex or Zirconia Frameworks

9. september 2026 oppdatert av: Maged Alameri, Kafrelsheikh University

Microbial Adhesion and Peri-Implant Tissue Health in All-on-Four Hybrid Prosthesis Supported by Zantex or Zirconia Framework. A Randomized Clinical Trial

This study compares two materials (Zantex and Zirconia) used to make fixed full-arch dental prostheses supported by four dental implants (the "All-on-Four" technique) in patients who have no natural teeth in the lower jaw. The study will evaluate how much bacteria builds up on each material and how healthy the gum tissue around the implants stays over time. Each patient will receive one type of prosthesis (either Zantex or Zirconia framework), and will be followed for three months after treatment. The goal is to help determine which material may provide better oral health outcomes for patients receiving this type of dental treatment.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Complete edentulism remains a major clinical challenge, particularly among aging populations. All-on-Four fixed implant-supported prostheses have become a widely used solution, but the long-term success of these restorations depends heavily on the framework material used, including its resistance to microbial adhesion and its effect on peri-implant tissue health.

This randomized clinical trial compares two framework materials: Zirconia, a high-strength ceramic material, and Zantex, a fiber-reinforced polymer material, both used to fabricate mandibular hybrid prostheses supported by four implants placed following the All-on-Four protocol.

Microbial adhesion will be assessed by evaluating biofilm accumulation on the prosthesis frameworks retrieved under sterile conditions at set time intervals. Peri-implant tissue health will be evaluated clinically at 1 week, 2 weeks, 1 month, and 3 months following prosthesis delivery, using standard clinical parameters including modified plaque index, modified bleeding on probing, and probing depth.

A total of 14 patients (7 per group) will be enrolled based on sample size calculations targeting 90% statistical power.

Studietype

Intervensjonell

Registrering (Antatt)

14

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiesteder

  • Egypt
    • Kafr el-Sheikh Governorate
      • Kafr ash Shaykh, Kafr el-Sheikh Governorate, Egypt, 33511
        • Rekruttering
        • Faculty of Dentistry, Kafrelsheikh University
        • Ta kontakt med:

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:

  1. Completely edentulous patients in the mandibular arch.
  2. Patients with a completely edentulous maxillary arch rehabilitated with a conventional complete denture.
  3. Patients with sufficient mandibular bone volume and quality to allow placement of four implants according to the All-on-Four treatment concept.
  4. Patients suitable for placement of two axial anterior implants in the canine regions and two distally tilted posterior implants anterior to the mental foramina.
  5. Patients with adequate restorative space to accommodate a full-arch hybrid prosthesis.
  6. Patients who are willing and able to maintain adequate oral hygiene and attend all scheduled follow-up appointments.

  7. Patients who are willing to participate in the study and sign the informed consent form.

    -

Exclusion Criteria:

  • 1. Patients with systemic conditions that contraindicate implant surgery or may adversely affect osseointegration or wound healing.

    2. Patients receiving medications or undergoing treatments that significantly affect bone metabolism or healing.

    3. Patients with a history of radiotherapy involving the head and neck region that may compromise implant therapy.

    4. Patients with active or uncontrolled periodontal or oral infections. 5. Patients with inadequate mandibular bone volume or unfavorable anatomical conditions that prevent placement of four implants according to the planned All-on-Four protocol without additional augmentation procedures.

    6. Patients with severe parafunctional habits, such as uncontrolled bruxism, that may compromise the prosthetic rehabilitation.

    7. Patients unable or unwilling to maintain appropriate oral hygiene. 8. Patients unable to attend the scheduled follow-up visits. 9. Patients who decline to participate or fail to provide informed consent

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: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Zirconia Framework Group
Mandibular hybrid prosthesis fabricated with Zirconia framework, supported by four implants following the All-on-Four protocol.
Enhet: Zirconia Framework
A metal-free zirconia ceramic framework used to fabricate a screw-retained mandibular hybrid prosthesis supported by four dental implants (All-on-Four protocol)
Eksperimentell: Zantex Framework Group
Mandibular hybrid prosthesis fabricated with Zantex (fiber-reinforced polymer) framework, supported by four implants following the All-on-Four protocol.
Enhet: Zantex Framework
A fiber-reinforced polymer (Zantex) metal-free framework used to fabricate a screw-retained mandibular hybrid prosthesis supported by four dental implants (All-on-Four protocol).

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Microbial Adhesion on Prosthesis Framework
Tidsramme: At 1 week, 1 month, and 3 months after prosthesis delivery
Quantitative assessment of bacterial biofilm accumulation on the intaglio surface of the prosthesis framework, measured using microbiological culture/colony counting techniques.
At 1 week, 1 month, and 3 months after prosthesis delivery

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Modified Plaque Index
Tidsramme: At 1 week, 2 weeks, 1 month, and 3 months after prosthesis delivery
Modified Plaque Index (mPI) assessed using a standardized plastic periodontal probe at multiple sites around each implant, scored on a scale from 0 to 3, where higher scores indicate greater plaque accumulation (worse outcome).
At 1 week, 2 weeks, 1 month, and 3 months after prosthesis delivery
Modified Bleeding on Probing Index (mBOP)
Tidsramme: At 1 week, 2 weeks, 1 month, and 3 months after prosthesis delivery
Modified Bleeding on Probing (mBOP) assessed using a standardized plastic periodontal probe at multiple sites around each implant, scored on a scale from 0 to 3, where higher scores indicate greater bleeding tendency (worse outcome).
At 1 week, 2 weeks, 1 month, and 3 months after prosthesis delivery
Probing Depth
Tidsramme: At 1 week, 2 weeks, 1 month, and 3 months after prosthesis delivery
At 1 week, 2 weeks, 1 month, and 3 months after prosthesis delivery

Samarbeidspartnere og etterforskere

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

Sponsor

Kafrelsheikh 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)

18. august 2026

Primær fullføring (Antatt)

30. mars 2027

Studiet fullført (Antatt)

30. juni 2027

Datoer for studieregistrering

Først innsendt

3. september 2026

Først innsendt som oppfylte QC-kriteriene

9. september 2026

Først lagt ut (Faktiske)

10. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

9. september 2026

Sist bekreftet

1. september 2025

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • KFSIRB200-722

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

produkt produsert i og eksportert fra USA

Nei

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