Dental Implants for Tooth Loss

Recruiting in Palo Alto (17 mi)

Overseen ByDavid Kim, DDS, DMSc

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Harvard Medical School (HMS and HSDM)

No Placebo Group

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.

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.

+9 more

Trial 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)

Participant Groups

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.

1Treatment groups

Experimental Treatment

Group I: dental implant placement and immediate temporary restorationExperimental Treatment1 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