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)

Must not be taking: Bone turnover medications

Disqualifiers: Untreated periodontal disease, Diabetes, Malignancy, Autoimmune, others

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

Compensation: Varies

Number of Visits: 8

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new type of dental implant for individuals missing teeth. The goal is to evaluate the implants' performance over two years, with regular check-ups and X-rays to monitor progress. Participants receive a temporary tooth replacement immediately after the dental implant placement. Ideal candidates need dental implants, have no serious health issues, and are not on medications that affect bone. As an unphased trial, this study allows participants to contribute to innovative dental research and potentially benefit from advanced implant technology.

Will I have to stop taking my current medications?

The trial requires that participants are not on medications that might affect bone turnover, except for estrogen/progesterone therapy. If you are taking such medications, you may need to stop them to participate.

What prior data suggests that this dental implant system is safe for patients with missing teeth?

Research has shown that dental implants are generally safe and effective for most people. One study found that 99.9% of dental implants remained stable without issues. Another study reported that 95.6% of implants continued to function well after 38 to 40 years. Even when placed immediately after tooth removal, about 95.7% of implants lasted without problems. These high success rates suggest that dental implants are a reliable option for replacing missing teeth. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this dental implant treatment because it offers immediate temporary restoration right after the implant is placed. Unlike traditional methods that often require a waiting period before placing a provisional crown, this approach allows for quicker functionality and aesthetics. Additionally, the use of advanced imaging techniques, like cone beam computed tomography and dental optical scans, ensures precise implant placement, which can lead to better long-term outcomes. This streamlined process not only enhances patient satisfaction by restoring smiles faster but also holds the potential for improved implant success rates.

What evidence suggests that dental implant placement is effective for tooth loss?

Research has shown that dental implants effectively treat tooth loss. One study found that 99.9% of implants last without problems, demonstrating their reliability. Another study showed that after 38–40 years, 95.6% of implants remained in place. Overall, implants have a 97% success rate after 10 years, proving their long-term effectiveness. However, teeth adjacent to implants might face a higher risk of issues like root fractures. Participants in this trial will receive dental implant placement and immediate temporary restoration to evaluate these outcomes. ^{3 4 5 6 7}

Who Is on the Research Team?

David Kim, DDS, DMSc

Principal Investigator

Harvard School of Dental Medicine

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11872292/

Outcomes of Dental Implants in Routine Clinical Practice Results: The implant survival rate was 99.9%, with only one implant failure observed in a 71-year-old female with subcrestal placement. Implants ...

2. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/cid.13443

Outcome of Single Dental Implants Over 38–40 Years: A ... The cumulative survival rates were 95.6% for the implants and 60.9% for the implant-supported crowns after 38–40 years in function. The marginal ...

3. nature.com nature.com/articles/s41432-024-01052-0

Dental implants significantly increase adjacent tooth loss ... The study found that teeth adjacent to dental implants had a significantly higher risk of tooth loss, primarily due to root fractures.

4. jomos.org jomos.org/articles/mbcb/full_html/2022/02/mbcb210065/mbcb210065.html

Implant failure rate and the prevalence of associated risk ... The use of dental implants is now a reliable treatment for edentulism with a success rate of 97% at 10 years and 75% at 20 years [1,2]. As in ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2666534425000042

Dental implant prevalence and durability: A concise review ... Ongoing research will further define their long-term performance. Dental implants are a common solution for tooth loss, but failure rates can reach 23 %, ...

6. nature.com nature.com/articles/s41415-023-5504-7

Survival of immediate implants replacing traumatised teeth ... Of the 70 implants placed, three failed resulting in an implant survival rate of 95.7% over the evaluation period. All the failed implants were ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8359846/

Long term clinical performance of 10 871 dental implants with ... According to life table analysis, at the implant level the cumulative survival rate at 3, 5, 10, and 15 years was 98.9%, 98.5%, 96.8%, and 94.0%, respectively ...