Dental Implants with Bone Grafts for Toothless Patients

Overseen By Robin Henderson, DDS, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Oklahoma

Must not be taking: Bisphosphonates

Disqualifiers: Uncontrolled disease, Smoking, Radiotherapy, Pregnancy, Periodontal disease, others

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

Compensation: Varies

Number of Visits: 7

60 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are using bisphosphonates, you cannot participate.

What data supports the effectiveness of the treatment Autogenous Mineralized and Demineralized Dentin Grafts for dental implant placement?

Research shows that using dentin grafts, made from a patient's own teeth, can effectively support new bone growth needed for dental implants. Studies have found high implant survival rates and successful bone formation with minimal complications, suggesting this method is a reliable option for patients needing dental implants. ^{1 2 3 4 5}

Is the use of dentin grafts for dental implants safe?

Research shows that dentin grafts, including autogenous (from the same person) and demineralized types, have similar safety outcomes to other graft materials, with no significant differences in complications or bone healing. This suggests they are generally safe for use in humans. ^{1 6 7 8 9}

How is the treatment using Autogenous Mineralized and Demineralized Dentin Grafts for dental implants unique?

This treatment is unique because it uses the patient's own teeth, processed into a demineralized dentin matrix, as a graft material. This approach leverages the natural similarity between tooth and bone, providing growth factors that support bone regeneration, and avoids the need for additional surgeries to harvest bone from other parts of the body. ^{2 6 9 10 11}

What is the purpose of this trial?

This trial is testing new tooth-based bone grafts against standard human bone grafts in patients needing bone grafts for dental implants. The grafts help new bone grow to support the implants by acting like a scaffold.

Research Team

Robin Henderson, DDS, MS

Principal Investigator

University of Oklahoma

Eligibility Criteria

This trial is for adults aged 18 to 80 with well-controlled health conditions, who need dental implants and can consent to study requirements. It's not for those with recent head/neck radiation, active gum disease, uncontrolled health issues, heavy smokers, bisphosphonate users, or pregnant/lactating women.

Inclusion Criteria

I am 18 years or older and considering dental implants.

My chronic illness is well-managed.

You are able to understand and sign a written informed consent form and willing to fulfill all study requirements.

Exclusion Criteria

You smoke more than 10 cigarettes per day.

I am currently using or have used bisphosphonates.

I have active gum disease.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Surgical Intervention

Surgical intervention for implant placement for all groups

1 day

1 visit (in-person)

Follow-up

Participants are monitored for implant stability and bone level changes

6 months

5 visits (in-person)

Restoration

Restoration of the implant by the restorative dentist

1-2 weeks

Treatment Details

Interventions

• Autogenous Mineralized and Demineralized Dentin Grafts
• Dental Implant Placement

Trial Overview The trial tests if mineralized or partially demineralized dentin grafts used in dental implant placement are as effective as the standard cadaver bone graft (FDBA) in terms of implant stability and success rates without requiring a second surgical site.

Participant Groups

Group I: mineralized tooth graft Experimental Treatment 1 Intervention

edentulous site grafted with mineralized tooth graft in the previous study.

Group II: Partially-demineralized tooth graft Experimental Treatment 1 Intervention

edentulous site grafted with partially-demineralized tooth graft in the previous study.

Group III: Freeze-Dried Bone Allograft Experimental Treatment 1 Intervention

edentulous site grafted with FDBA in previous study.

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials

484

Recruited

95,900+

Zimmer Biomet

Industry Sponsor

Trials

383

Recruited

67,800+

Dr. Nitin Goyal

Zimmer Biomet

Chief Medical Officer since 2021

MD from Harvard Medical School

Ivan Tornos

Zimmer Biomet

Chief Executive Officer since 2023

MBA from the University of Miami School of Business, BBA in Finance and International Marketing and Management from the University of Georgia Terry College of Business

References

1. United States pubmed.ncbi.nlm.nih.gov

AUTOGENOUS DENTIN GRAFTS HAVE COMPARABLE SHORT-TERM OUTCOMES TO OTHER GRAFT MATERIALS REGARDING IMPLANT STABILITY, PREIMPLANT MARGINAL BONE LOSS, AND COMPLICATION RATE. [2023]

2. Bulgaria pubmed.ncbi.nlm.nih.gov

Auto-tooth bone graft material for reconstruction of bone defects in the oral region: case reports. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Implants Survival Rate in Regenerated Sites with Innovative Graft Biomaterials: 1 Year Follow-Up. [2021]

4. Spain pubmed.ncbi.nlm.nih.gov

Twenty Years-Passed Case of Demineralized Dentin Matrix Autograft for Sinus Bone Augmentation - A First Case of Dentin Graft in Human. [2023]

5. Denmark pubmed.ncbi.nlm.nih.gov

Osteogenic potential of autogenic demineralized dentin implanted in bony defects in dogs. [2019]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Dentin, Dentin Graft, and Bone Graft: Microscopic and Spectroscopic Analysis. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Demineralized Xenogenic Dentin and Autogenous Bone as Onlay Grafts to Rabbit Tibia. [2018]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Evaluation of the Efficacy of Mineralized Dentin Graft in the Treatment of Intraosseous Defects: An Experimental In Vivo Study. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Guided Bone Regeneration Using Demineralized Dentin Matrix: Long-Term Follow-Up. [2016]

10. United States pubmed.ncbi.nlm.nih.gov

A comparative volumetric study of symphysis donor defects, unfilled or filled with bone substitute. [2013]

11. United States pubmed.ncbi.nlm.nih.gov

Demineralized Dentin Matrix (DDM) As a Carrier for Recombinant Human Bone Morphogenetic Proteins (rhBMP-2). [2019]