NCT07090863

Brief Summary

This research is being done to evaluate the clinical, technical, biological, and aesthetic results of two different fabrication methods (additive and subtractive) for creating implant-supported fixed dental prostheses (iFDPs). Patients will receive an iFDP, meaning an implant-supported crown, according to regular treatment protocols. The fabrication method used to create the implant-supported crown will be decided in a randomised way. Clinical and radiological examinations will be performed prior to and when receiving the implant-supported crown and during a follow-up period of 3 years. Furthermore, technician- and patient-reported outcomes will be evaluated used questionnaires.

Trial Health

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Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
39mo left

Started Jul 2025

Longer than P75 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress19%
Jul 2025Jul 2029

First Submitted

Initial submission to the registry

July 8, 2025

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 29, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

July 30, 2025

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2029

Last Updated

August 5, 2025

Status Verified

July 1, 2025

Enrollment Period

4 years

First QC Date

July 8, 2025

Last Update Submit

July 31, 2025

Conditions

Dental Prosthesis, Implant-Supported

Keywords

3D-printingimplant-supported prosthesesadditive manufacturing

Outcome Measures

Primary Outcomes (1)

  • Clinical success

    The primary outcome is clinical success of the iFDPs, which is defined as the iFDPs being free of all complications over the entire observation period.

    This outcome will be evaluated at the baseline and at the follow-up visits after 1 year, 2 years and 3 years

Secondary Outcomes (11)

  • Efficiency during manufacturing (dental technician) (time)

    Periprocedural

  • Efficiency during manufacturing

    Periprocedural

  • Chairside adjustment time

    Periprocedural

  • Survival rate

    This outcome will be reported on the baseline visit and the follow-up visits after 1, 2 and 3 years

  • Probing Depth

    This outcome will be assessed at the baseline visit and the follow-up visits after 1, 2 and 3 years.

  • +6 more secondary outcomes

Study Arms (2)

Additive manufacturing

EXPERIMENTAL

additively manufactured implant-supported prostheses

Device: AM manufacturing method

Subtractive manufacturing

ACTIVE COMPARATOR

subtractively manufactured implant-supported prostheses

Device: SM manufacturing method

Interventions

AM manufacturing methodDEVICE

additively manufactured implant-supported prostheses

Additive manufacturing
SM manufacturing methodDEVICE

subtractively manufactured implant-supported prostheses

Subtractive manufacturing

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed Informed Consent Form in English language
  • ≥ 20 years of age
  • In need of at least one definitive screw retained premolar or molar iFDP on an existing dental implant (Straumann AG)
  • Presence of at least one adjacent tooth at the implant site
  • Adequate oral hygiene
  • Capability to comply with the study procedures

You may not qualify if:

  • Pregnant or lactating women
  • Known or suspected non-compliance, drug or alcohol abuse
  • Severe periodontal and peri-implant disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Harvard School of Dental Medicine

Boston, Massachusetts, 02115, United States

Location

Center of Dental Medicine, University of Zurich

Zurich, Canton of Zurich, 8032, Switzerland

Location

Study Officials

  • German O Gallucci, Professor

    Harvard School of Dental Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kevser Pala, Dr.med.dent

CONTACT

+41764084037kevser.pala@zzm.uzh.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomised controlled clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 8, 2025

First Posted

July 29, 2025

Study Start

July 30, 2025

Primary Completion (Estimated)

July 20, 2029

Study Completion (Estimated)

July 20, 2029

Last Updated

August 5, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

IPD used in the results publication

Locations

US(1)CH(1)