Manufacturing Methods for Implant-Supported Dental Prosthesis

Not yet recruiting at 1 trial location

Overseen By Kevser Pala, Dr.med.dent

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Harvard Medical School (HMS and HSDM)

Disqualifiers: Pregnancy, Drug abuse, Severe periodontal disease

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: Periprocedural

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two methods for creating implant-supported crowns, used to replace missing teeth. The study compares additive (3D printing) and subtractive (carving from a block) manufacturing techniques to determine which performs better in function, appearance, and comfort. Individuals with a dental implant needing a new crown on a back tooth, who maintain good oral hygiene, and can follow study instructions may be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to advancements in dental technology and enhance future dental care options.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these fabrication methods for implant-supported dental prostheses are safe?

Research has shown that both 3D printing and traditional manufacturing methods for dental implants are well-tolerated by patients. A study comparing these methods found that both influence the strength of the implants, such as their ability to withstand pressure before breaking. However, neither method reported specific safety issues.

Previous research has demonstrated that implants made with either 3D printing or traditional methods are as accurate as older techniques, making them reliable options for dental implants. Available studies have not reported major negative effects.

Since this trial is in the "Not Applicable" phase, it evaluates technical and clinical outcomes rather than safety. Generally, dental implants are considered safe when used according to standard treatment guidelines. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these methods for implant-supported dental prostheses because they offer innovative manufacturing approaches that could enhance patient outcomes. Unlike traditional techniques, which often rely on subtractive manufacturing methods like milling, the trial explores additive manufacturing, commonly known as 3D printing. This method allows for more precise customization of dental prostheses, potentially improving fit and comfort for patients. Additionally, additive manufacturing can reduce material waste and production time, making the process more efficient and sustainable. By comparing these two advanced techniques, researchers aim to determine which method provides superior results in terms of durability and patient satisfaction.

What evidence suggests that these manufacturing methods are effective for implant-supported dental prostheses?

This trial will compare two promising methods for creating implant-supported dental prostheses (iFDPs): additive and subtractive manufacturing. Participants in one arm of the trial will receive prostheses made through additive manufacturing, which builds the prosthesis layer by layer for precise and customized pieces. Participants in another arm will receive prostheses crafted through subtractive manufacturing, which involves carving the prosthesis from a solid block. This method has demonstrated a high success rate of 97.8% for dental restorations. Although direct comparison data between the two methods is limited, both aim to enhance the fit and feel of dental implants. Ongoing research in this trial seeks to determine which method might yield better results over time. ^{1 2 6 7 8}

Who Is on the Research Team?

German O Gallucci, Professor

Principal Investigator

Harvard School of Dental Medicine

Are You a Good Fit for This Trial?

This trial is for individuals needing implant-supported fixed dental prostheses (iFDPs). Specific eligibility criteria are not provided, but typically participants would have missing teeth and be suitable candidates for dental implants.

Inclusion Criteria

Capability to comply with the study procedures

I have at least one tooth next to where my implant will go.

I maintain good oral hygiene.

Exclusion Criteria

Pregnant or lactating women

I have severe gum and dental implant disease.

Known or suspected non-compliance, drug or alcohol abuse

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single implant-supported crown fabricated according to group allocation (additively or subtractively manufactured)

Periprocedural

1 visit (in-person)

Follow-up

Participants are monitored for clinical, technical, biological, and aesthetic outcomes, as well as technician- and patient-reported outcomes

3 years

Annual visits (in-person) at 1, 2, and 3 years

What Are the Treatments Tested in This Trial?

Interventions

• Additively Manufactured Implant Supported Fixed Dental Prostheses
• Subtractively Manufactured Implant Supported Fixed Dental Prostheses

Trial Overview The study compares two methods of making iFDPs: additive manufacturing (AM) and subtractive manufacturing (SM). Patients will receive an iFDP made by one of these methods, chosen randomly. The outcomes will be monitored over a 3-year period through clinical exams, radiological assessments, and questionnaires.

How Is the Trial Designed?

Group I: Additive manufacturing Experimental Treatment 1 Intervention

additively manufactured implant-supported prostheses

Group II: Subtractive manufacturing Active Control 1 Intervention

subtractively manufactured implant-supported prostheses

Who Is Running the Clinical Trial?

Harvard Medical School (HMS and HSDM)

Lead Sponsor

Trials

208

Recruited

1,421,000+

University of Zurich

Collaborator

Trials

1,212

Recruited

1,304,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37750533/

Additively and subtractively manufactured implant- ... To compare and report on the performance of implant-supported fixed dental prostheses (iFDPs) fabricated using additive (AM) or subtractive (SM) manufacturing.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07090863

Additively Versus Subtractively Manufactured Implant ... This research is being done to evaluate the clinical, technical, biological, and aesthetic results of two different fabrication methods (additive and ...

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/clr.14085

Additively and subtractively manufactured implant ... To compare and report on the performance of implant-supported fixed dental prostheses (iFDPs) fabricated using additive (AM) or subtractive (SM) manufacturing.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0300571225004439

A retrospective clinical study of 145 patients with up to 2 ... To present the 2-year clinical outcomes of short-span implant-supported hybrid composite restorations, namely single crowns (SCs) and fixed partial prostheses ( ...

5. researchgate.net researchgate.net/profile/Franz-Strauss/publication/374226438_Additively_and_subtractively_manufactured_implant-supported_fixed_dental_prostheses_A_systematic_review/links/651a60e91e2386049def3bd9/Additively-and-subtractively-manufactured-implant-supported-fixed-dental-prostheses-A-systematic-review.pdf

supported fixed dental prostheses: A systematic review At present, there is very limited in vitro and no clinical data available comparing additively manufactured (AM) fixed implant- supported dental prostheses ...

6. iti.org iti.org/academy/consensus-database/consensus-statement/-/consensus/additively-and-subtractively-manufactured-implant-supported-fixed-dental-prostheses/2101

Additively and Subtractively Manufactured Implant- ... Both additive and subtractive CAM techniques can influence the mechanical properties (fracture loads and bending moments) of tooth-colored iFDPs.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0022391322004905

Immediate loaded fixed complete dentures supported by ... The purpose of this retrospective clinical study was to assess the clinical outcomes of immediate loaded fixed complete dentures in individuals with a history ...

8. researchgate.net researchgate.net/publication/359397459_Accuracy_of_Fixed_Implant-Supported_Dental_Prostheses_Additively_Manufactured_by_Metal_Ceramic_or_Polymer_A_Systematic_Review

Accuracy of Fixed Implant‐Supported Dental Prostheses ... AM implant-supported fixed prostheses demonstrate similar accuracy compared to conventional and computer-aided design and computer-aided manufacturing ...