NCT04029025

Brief Summary

This study is to assess socio-economic factors, clinical and virtual precision, patient-centered outcomes, and esthetics during the treatment with monolithic multi-unit iFDPs in a complete digital workflow

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 26, 2019

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

July 17, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 23, 2019

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

November 7, 2023

Status Verified

November 1, 2023

Enrollment Period

3.8 years

First QC Date

July 17, 2019

Last Update Submit

November 6, 2023

Conditions

Partial-edentulismImplant-supported Fixed Dental Prostheses (iFDP)

Keywords

conventional porcelain-fused-to metal iFDPDentalwings DWOS Intraoral Scan3Shape TRIOS Pod Intraoral ScanDentalwings DWOS Implant Prosthetics Lab-SoftwareStraumann CARES Lab-Softwaredigital implant workflowCAD/CAM-technology

Outcome Measures

Primary Outcomes (1)

  • work time (days)

    work time for preparation, each production step such as computer-based design, waiting times between the various process steps, e.g. postal delivery from the external milling center, bonding of the full-contoured iFDPs to the prefabricated titanium abutments

    from preparation to bonding of the full-contoured iFDPs to the prefabricated titanium abutments (an average of 35 days)

Secondary Outcomes (4)

  • number of clinical appointments

    from preparation to bonding of the full-contoured iFDPs to the prefabricated titanium abutments (an average of 35 days)

  • chair-time in units per minutes

    from preparation to bonding of the full-contoured iFDPs to the prefabricated titanium abutments (an average of 35 days)

  • volumetric difference

    at Visit 3 (an average of 30 days)

  • Change in Functional Implant Prosthodontic Score (FIPS)

    at Visit 3 (an average of 30 days), Visit 4 (an average of 35 days), Visit 5 (6 months Follow-up), Visit 6 (12 months Follow-up), Visit 7 (24 months Follow-up), Visit 8 (36 months Follow-up)

Study Arms (3)

Workflow A

ACTIVE COMPARATOR

Dentalwings DWOS Intraoral Scan (IOS A) + Dentalwings DWOS Implant Prosthetics Lab-Software (CAD A)

Procedure: Workflow A

Workflow B

ACTIVE COMPARATOR

3Shape TRIOS Pod Intraoral Scan (IOS B) + Straumann CARES Lab-Software (CAD B)

Procedure: Workflow B

Workflow C

ACTIVE COMPARATOR

Conventional Impression + conventional porcelain-fused-to metal iFDP (LabS C/CAD C).

Procedure: Workflow C

Interventions

Workflow APROCEDURE

Dentalwings DWOS Intraoral Scan (IOS A) + Dentalwings DWOS Implant Prosthetics Lab-Software (CAD A)

Workflow A
Workflow BPROCEDURE

3Shape TRIOS Pod Intraoral Scan (IOS B) + Straumann CARES Lab-Software (CAD B)

Workflow B
Workflow CPROCEDURE

Conventional Impression + conventional porcelain-fused-to metal iFDP (LabS C/CAD C)

Workflow C

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • unit implant-supported Fixed Dental Prostheses (iFDP) in maxillary and mandibular sites for the replacement of premolars or molars
  • at least one interproximal contact and occlusal contacts to the antagonists

You may not qualify if:

  • uncontrolled systemic disease that would interfere with dental implant therapy
  • patients who smoke \> 10 cigarettes per day or tobacco equivalents
  • alcohol and/or drug abuse
  • patients with chronic pain
  • patients with untreated periodontitis and / or inadequate oral hygiene
  • medical conditions requiring chronic high dose steroid therapy or anti-resorptive treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitäres Zentrum für Zahnmedizin Basel UZB, Universität Basel

Basel, 4056, Switzerland

Location

Related Publications (2)

  • Gintaute A, Weber K, Zitzmann NU, Bragger U, Ferrari M, Joda T. A Double-Blind Crossover RCT Analyzing Technical and Clinical Performance of Monolithic ZrO2 Implant Fixed Dental Prostheses (iFDP) in Three Different Digital Workflows. J Clin Med. 2021 Jun 16;10(12):2661. doi: 10.3390/jcm10122661.

    PMID: 34208773RESULT

  • Joda T, Gintaute A, Bragger U, Ferrari M, Weber K, Zitzmann NU. Time-efficiency and cost-analysis comparing three digital workflows for treatment with monolithic zirconia implant fixed dental prostheses: A double-blinded RCT. J Dent. 2021 Oct;113:103779. doi: 10.1016/j.jdent.2021.103779. Epub 2021 Aug 13.

    PMID: 34391875RESULT

Study Officials

  • Tim Joda, Prof. Dr.

    Universitäres Zentrum für Zahnmedizin Basel UZB, Universität Basel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Model Details: Double-blinded double-randomized controlled trial (RCT) with crossover design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2019

First Posted

July 23, 2019

Study Start

June 26, 2019

Primary Completion

March 31, 2023

Study Completion

June 30, 2023

Last Updated

November 7, 2023

Record last verified: 2023-11

Locations

CH(1)