Dental Implants for Tooth Loss

Overseen By Chia-Yu Chen, DDS, DMSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Harvard Medical School (HMS and HSDM)

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

Compensation: Varies

Number of Visits: 8

30 Participants Needed

Trial Summary

What is the purpose of this trial?

The primary objective of this study is to observe the performance of an implant system with a new surface (EK III NH dental implants) over a period of two years. The implants will be placed in the upper and lower jaws of patients with missing teeth and immediately given a temporary restoration. The investigators will document the performance of the implants through regular dental check-ups and X-rays.

Research Team

David Kim, DDS, DMSc

Principal Investigator

Harvard School of Dental Medicine

Eligibility Criteria

This trial is for healthy adults aged 20-80 who want dental implants to replace missing teeth and are willing to follow up. It's not suitable for those on medications that could affect the outcome or with significant medical histories.

Inclusion Criteria

I am between 20 and 80 years old and want dental implants to replace missing teeth.

Subjects are willing to sign an informed consent, participate, and return for follow-up visits

I am not on any medications that could affect the study results.

Exclusion Criteria

I need a bone or soft tissue graft before or during my implant surgery.

I am not on medication that affects bone health, except for hormone therapy.

I have used nicotine products within the last three weeks.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Pre-operative

Comprehensive exam, standard-of-care x-rays, cone beam computed tomography (CBCT), dental optical scan

1 week

1 visit (in-person)

Intra-operative

Dental implant placement and immediate provisionalization

1 day

1 visit (in-person)

Follow-up

4-week follow-up to assess implant stability and healing

4 weeks

1 visit (in-person)

Impression and Restoration

12-week impression and delivery of final restoration

8 weeks

2 visits (in-person)

Long-term Follow-up

Follow-ups at 1 year and 2 years post-implant restoration to monitor implant stability and bone level changes

2 years

2 visits (in-person)

Treatment Details

Interventions

• Dental Implant Placement

Trial Overview The study tests a new dental implant system (EK III NH) used immediately after placement. Over two years, patients will receive regular check-ups and X-rays to assess how well these implants perform.

Participant Groups

Group I: dental implant placement and immediate temporary restoration Experimental Treatment 1 Intervention

1. pre-operative: comprehensive exam, standard-of-care x-rays, cone beam computed tomography (CBCT), dental optical scan 2. intra-operative: dental implant placement and immediate provisionalization 3. 4-week follow-up 4. 12-week impression 5. Delivery of final restoration 6. follow-ups at 1 year and 2-year post-implant restoration

Who Is Running the Clinical Trial?

Harvard Medical School (HMS and HSDM)

Lead Sponsor

Trials

208

Recruited

1,421,000+