Additively Versus Subtractively Manufactured Implant Supported Fixed Dental Prostheses

Harvard Medical School (HMS and HSDM)

Status: Not yet enrolling

Conditions: Dental Prosthesis, Implant-Supported

Treatments: Device: AM manufacturing method; Device: SM manufacturing method

Study type: Interventional

Funder types: Other

Identifiers

NCT07090863

3DP-Implant-Crown

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups

Additive manufacturing

Experimental group

Description:

additively manufactured implant-supported prostheses

Treatment:

Device: AM manufacturing method

Subtractive manufacturing

Active Comparator group

Description:

subtractively manufactured implant-supported prostheses

Treatment:

Device: SM manufacturing method