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Jaw Tracking Impact on Occlusion and Patient Outcomes in Maxillary Implant Restorations

3. juli 2026 opdateret af: Shahira Saad Abd ElKhabeer Mohamed Elsyed Ali, Mansoura University

Jaw Tracking Impact on Occlusion and Patient Outcomes in Maxillary Implant Restorations: Randomized Clinical Trial

This randomized clinical trial aims to evaluate the effect of integrating digital jaw tracking into the workflow for fabrication of full-arch maxillary implant-supported screw-retained restorations. Twenty completely edentulous maxillary patients opposing natural mandibular dentition will be randomly assigned to either a conventional workflow group or a digital jaw-tracking workflow group. The study will compare patient satisfaction and occlusal accuracy between the two groups. Patient satisfaction will be assessed using a visual analogue scale (VAS), while occlusal accuracy will be evaluated using the OccluSense system.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This randomized clinical trial will compare conventional prosthetic workflow with a digital jaw-tracking workflow for the fabrication of full-arch maxillary implant-supported screw-retained restorations.

Twenty edentulous patients with completely edentulous maxillary arches opposing natural mandibular dentition will be recruited and randomly allocated into two equal groups. Group A will receive restorations fabricated using the conventional workflow with static jaw relation records, while Group B will receive restorations fabricated using a digital workflow incorporating dynamic jaw tracking and a virtual articulator.

The primary outcome will be patient satisfaction, assessed using a visual analogue scale (VAS) after prosthesis insertion and during follow-up visits. Occlusal accuracy will be evaluated using the OccluSense digital occlusal analysis system. The study aims to determine whether digital jaw tracking improves occlusal accuracy and patient-reported outcomes compared with the conventional workflow.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

20

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Egypten
    • Dakahlia Governorate
      • Al Mansurah, Dakahlia Governorate, Egypten
        • Rekruttering
        • Faculty of Dentistry, Mansoura University

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

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Male or female patients aged 50 to 70 years.
  • Completely edentulous maxillary arch opposing natural mandibular dentition.
  • Skeletal Class I maxillomandibular relationship with normal occlusion.
  • Acceptable oral hygiene.
  • Willing and able to provide written informed consent and comply with study procedures.

Exclusion Criteria:

  • Systemic diseases affecting bone healing, such as uncontrolled diabetes mellitus or osteoporosis.
  • Harmful oral habits, including smoking, clenching, or bruxism.
  • Uncooperative patients or patients unable to comply with study procedures.

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: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Conventional Workflow
Participants will receive full-arch maxillary implant-supported screw-retained restorations fabricated using the conventional workflow with conventional jaw relation records and standard occlusal adjustment procedures.
Procedure: Conventional Prosthetic Workflow
Fabrication of a full-arch maxillary implant-supported screw-retained prosthesis using conventional jaw relation records, a facebow or average-value articulator, and conventional occlusal adjustment procedures.
Eksperimentel: Digital Jaw-Tracking Workflow
Participants will receive full-arch maxillary implant-supported screw-retained restorations fabricated using a digital workflow incorporating dynamic jaw tracking and a virtual articulator for patient-specific occlusal design.
Procedure: Digital Jaw-Tracking Workflow
Fabrication of a full-arch maxillary implant-supported screw-retained prosthesis using a digital workflow with dynamic jaw tracking, virtual articulator integration, and CAD/CAM technology for patient-specific occlusal design.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Patient Satisfaction
Tidsramme: At prosthesis insertion, 3 months, and 6 months after prosthesis insertion
Patient satisfaction will be assessed using a Visual Analogue Scale (VAS) to evaluate patient satisfaction with the implant-supported prosthesis regarding comfort, chewing ability, aesthetics, and phonetics.
At prosthesis insertion, 3 months, and 6 months after prosthesis insertion

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Occlusal Accuracy
Tidsramme: At prosthesis insertion and 3 months after insertion
Occlusal accuracy will be evaluated using the OccluSense digital occlusal analysis system by assessing the distribution and stability of occlusal contact points.
At prosthesis insertion and 3 months after insertion

Samarbejdspartnere og efterforskere

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

Sponsor

Mansoura University

Efterforskere

  • Ledende efterforsker: Shahira S Mohamed, BDS, Faculty of Dentistry, Mansoura 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 (Faktiske)

25. december 2025

Primær færdiggørelse (Anslået)

25. december 2026

Studieafslutning (Anslået)

25. januar 2027

Datoer for studieregistrering

Først indsendt

3. juli 2026

Først indsendt, der opfyldte QC-kriterier

3. juli 2026

Først opslået (Faktiske)

9. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • MS.25.12.99

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

There is no current plan to share individual participant data. Participant confidentiality will be maintained according to institutional ethical requirements.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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