NCT07090863

Additively Versus Subtractively Manufactured Implant Supported Fixed Dental Prostheses

Additively (AM) Versus Subtractively (SM) Manufactured Implant Supported Fixed Dental Prostheses (iFDPs)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Harvard Medical School (HMS and HSDM) · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Dental Prosthesis, Implant-Supported

Interventions

Type	Name	Description
DEVICE	AM manufacturing method	additively manufactured implant-supported prostheses
DEVICE	SM manufacturing method	subtractively manufactured implant-supported prostheses

Timeline

• Start date: 2025-07-30
• Primary completion: 2029-07-20
• Completion: 2029-07-20
• First posted: 2025-07-29
• Last updated: 2025-08-05

Locations

2 sites across 2 countries: United States, Switzerland

Regulatory

• FDA-regulated device study