Additively Versus Subtractively Manufactured Implant Supported Fixed Dental Prostheses

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-30

Study Completion Date

2029-07-20

Brief Summary

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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.

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Detailed Description

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This study is designed as a randomised controlled clinical trial with a multi-centre design. Patients in need of a definitive posterior implant-supported crown will be enrolled in this study following predefined eligibility criteria at two different study centres (Harvard School of Dental Medicine, Harvard University and Center of Dental Medicine, University of Zurich). Patients will receive a single implant-supported crown fabricated according to group allocation (additively or subtractively manufactured). After crown delivery, patients will be followed-up for an observation period of 3 years. The primary outcome is the clinical performance of the implant crowns. Clinical, technical, biological, and aesthetic results as well as the technician- and patient-reported outcomes will be assessed.

Conditions

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Dental Prosthesis, Implant-Supported

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomised controlled clinical trial

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Additive manufacturing

additively manufactured implant-supported prostheses

Group Type EXPERIMENTAL

AM manufacturing method

Intervention Type DEVICE

additively manufactured implant-supported prostheses

Subtractive manufacturing

subtractively manufactured implant-supported prostheses

Group Type ACTIVE_COMPARATOR

SM manufacturing method

Intervention Type DEVICE

subtractively manufactured implant-supported prostheses

Interventions

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AM manufacturing method

additively manufactured implant-supported prostheses

Intervention Type DEVICE

SM manufacturing method

subtractively manufactured implant-supported prostheses

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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