Additively Versus Subtractively Manufactured Implant Supported Fixed Dental Prostheses
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AM manufacturing method, SM manufacturing method.
- Who it may be relevant to
- Registry conditions: Dental Prosthesis, Implant-Supported. Basic parameters: from 20 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Additively (AM) Versus Subtractively (SM) Manufactured Implant Supported Fixed Dental Prostheses (iFDPs)
Overview
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.
Interventions
- Device AM manufacturing method
additively manufactured implant-supported prostheses - Device SM manufacturing method
subtractively manufactured implant-supported prostheses
Primary outcome measures
- Clinical success [Time frame: This outcome will be evaluated at the baseline and at the follow-up visits after 1 year, 2 years and 3 years]
Secondary outcome measures (11)
- Efficiency during manufacturing (dental technician) (time) [Time frame: Periprocedural]
- Efficiency during manufacturing [Time frame: Periprocedural]
- Chairside adjustment time [Time frame: Periprocedural]
- Survival rate [Time frame: This outcome will be reported on the baseline visit and the follow-up visits after 1, 2 and 3 years]
- Probing Depth [Time frame: This outcome will be assessed at the baseline visit and the follow-up visits after 1, 2 and 3 years.]
- Esthetic outcomes [Time frame: This outcome will be assessed at the baseline visit and the follow-up visits after 1, 2 and 3 years.]
- Technical outcomes [Time frame: this outcome will be assessed at the baseline visit and the follow-up visits after 1, 2 and 3 years.]
- Patient-reported outcomes [Time frame: This outcome will be assessed at the baseline and follow-up visits after 1, 2 and 3 years]
- Adverse events [Time frame: through study completion. This outcome will be reported at baseline and follow-up visits after 1, 2 and 3 years.]
- Bleeding on probing (BOP) [Time frame: This outcome will be assessed at the baseline visit and the follow-up visits after 1, 2 and 3 years.]
- Plaque control record [Time frame: This outcome will be assessed at the baseline visit and the follow-up visits after 1, 2 and 3 years.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Harvard School of Dental Medicine — Boston
Switzerland · 1 center
- Center of Dental Medicine, University of Zurich — Zurich
Identifiers
NCT: NCT07090863 · 3DP-Implant-Crown