Dental Prosthesis, Implant-SupportedNCT07090863
Additively Versus Subtractively Manufactured Implant Supported Fixed Dental Prostheses
A study testing AM manufacturing method and SM manufacturing method in people with Dental Prosthesis, Implant-Supported, run by Harvard Medical School (HMS and HSDM) at 2 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Dental Prosthesis, Implant-Supported
- What is being tested?
- AM manufacturing method and SM manufacturing method
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 30 Jul 2025to 20 Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnant or lactating women
- Known or suspected non-compliance, drug or alcohol abuse
- Severe periodontal and peri-implant disease
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
United States1 site
Harvard School of Dental Medicine
Boston, Massachusetts, 02115
German O Gallucci, Professor, 617-432-5764, german_gallucci@hsdm.harvard.edu
Switzerland1 site
Center of Dental Medicine, University of Zurich
Zurich, Canton of Zurich, 8032
Kevser Pala, Dr.med.dent, +41764084037, kevser.pala@zzm.uzh.ch
About this study
Official title: Additively (AM) Versus Subtractively (SM) Manufactured Implant Supported Fixed Dental Prostheses (iFDPs)
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.
Read the 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
- Being tested
- AM manufacturing method, SM manufacturing method
- Keywords
- 3D-printing, implant-supported prostheses, additive manufacturing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AM manufacturing methodDevice
additively manufactured implant-supported prostheses
SM manufacturing methodDevice
subtractively manufactured implant-supported prostheses
| Study group | Role | What they receive |
|---|---|---|
| Additive manufacturing | Experimental | additively manufactured implant-supported prostheses Receives: Device: AM manufacturing method |
| Subtractive manufacturing | Active comparator | subtractively manufactured implant-supported prostheses Receives: Device: SM manufacturing method |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Fabrication time for the iFDP will be measured in minutes. The time needed for the manufacturing (subtractively or additively), the post-processing and the cementation on to the titanium base will be measured using a stopwatch.
Measured: Periprocedural
Efficiency during manufacturing
The laboratory workflow during manufacturing will be assessed by the dental technicians using a questionnaire on success of the fabrication and postprocessing steps, and complications such as faulty/damaged iFDP. Dental technicians will report complications by answering yes/no to the occurrence of any complications, specifying occurred complications and reporting their quantity.
Measured: Periprocedural
Chairside adjustment time
The total mean time for chairside adjustment (min) at iFDP delivery. A stopwatch will be used to measure the minutes between removing the healing abutment of the implant and final insertion of the prostheses after finishing any potential adjustments (for example approximal/occlusal contacts, polishing)
Measured: Periprocedural
Survival rate
Survival will be defined as the presence of the iFDP independent of technical, biological or aesthetic complications.
Measured: This outcome will be reported on the baseline visit and the follow-up visits after 1, 2 and 3 years
Probing Depth
Measured from the gingival margin to the bottom of the probable pocket to the nearest millimeter using a University of North Carolina (UNC15) periodontal probe with 1 mm markings (Hu-Friedy, Chicago, IL. USA) with a light probing force (≃ 0.2 N)
Measured: This outcome will be assessed at the baseline visit and the follow-up visits after 1, 2 and 3 years.
Esthetic outcomes
Standardized photographs, occlusal and buccal aspect will be taken from each patient at each visit for documentation purposes and for evaluating the esthetic aspects. Outcomes will be assessed by using modified criteria of United States Public Health Services (USPHS) (Barnes, Arpante et al. 1995).
Measured: This outcome will be assessed at the baseline visit and the follow-up visits after 1, 2 and 3 years.
Technical outcomes
Technical outcomes of the iFDP will be assessed using modified criteria of United States Public Health Services (USPHS) (Barnes, Arpante et al. 1995).
Measured: this outcome will be assessed at the baseline visit and the follow-up visits after 1, 2 and 3 years.
Patient-reported outcomes
Patient satisfaction to the treatment and iFDP will be assessed with questions on Visual Analogue Scale (VAS). Patients will be asked questions regarding their satisfaction on a scale of 0 (not satisfied) to 100 (very satisfied) with the prostheses.
Measured: This outcome will be assessed at the baseline and follow-up visits after 1, 2 and 3 years
Adverse events
Any Adverse Event (AE) related or possibly related to the study procedures.
Measured: through study completion. This outcome will be reported at baseline and follow-up visits after 1, 2 and 3 years.
Bleeding on probing (BOP)
Presence of bleeding within 30 s after gently probing. The percentage of positive answers will be calculated.
Measured: This outcome will be assessed at the baseline visit and the follow-up visits after 1, 2 and 3 years.
Plaque control record
Presence of plaque evaluated dichotomously. The percentage of positive answers will be calculated.
Measured: This outcome will be assessed at the baseline visit and the follow-up visits after 1, 2 and 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start30 Jul 2025 (estimated)
- Primary completion20 Jul 2029 (estimated)
- Study completion20 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Prosthesis, Implant-SupportedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised controlled clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harvard Medical School (HMS and HSDM)
- Sponsor type
- University, hospital or other
- Collaborators
- University of Zurich
- Responsible party
- Principal investigator, German O. Gallucci, Harvard Medical School (HMS and HSDM)
- Investigators
- German O Gallucci, Professor, Principal investigator, Harvard School of Dental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07090863
- Sponsor's protocol ID
- 3DP-Implant-Crown
- Status last verified
- Jul 2025
- First submitted
- 8 Jul 2025
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: IPD used in the results publication
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Additively (AM) Versus Subtractively (SM) Manufactured Implant Supported Fixed Dental Prostheses (iFDPs)
- ClinicalTrials.gov ID
- NCT07090863
- Acronym / sponsor ID
- 3DP-Implant-Crown
- Conditions
- Dental Prosthesis, Implant-Supported
- Keywords
- 3D-printing, implant-supported prostheses, additive manufacturing
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Harvard Medical School (HMS and HSDM)University, hospital or other
- Collaborators
- University of Zurich
- Study start
- 30 Jul 2025 (estimated)
- Primary completion
- 20 Jul 2029 (estimated)
- Study completion
- 20 Jul 2029 (estimated)
- First posted
- 29 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomised controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Additive manufacturing | Experimental | Device: AM manufacturing methodadditively manufactured implant-supported prostheses |
| Subtractive manufacturing | Active comparator | Device: SM manufacturing methodsubtractively manufactured implant-supported prostheses |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Pregnant or lactating women
- Known or suspected non-compliance, drug or alcohol abuse
- Severe periodontal and peri-implant disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AM manufacturing methodadditively manufactured implant-supported prostheses | Device | Additive manufacturing |
| SM manufacturing methodsubtractively manufactured implant-supported prostheses | Device | Subtractive manufacturing |
Primary outcome
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
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.
11 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- Individual participant dataSharing planned: Yes. IPD used in the results publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
German O Gallucci, Professor principal investigator
Harvard School of Dental Medicine
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AM manufacturing method and SM manufacturing method in people with Dental Prosthesis, Implant-Supported, run by Harvard Medical School (HMS and HSDM) at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kevser Pala, Dr.med.dent (+41764084037, kevser.pala@zzm.uzh.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2025.