Dental Implants for Tooth Replacement

No longer recruiting at 1 trial location

Overseen By Bader s albader, DDS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Loma Linda University

Must not be taking: Intravenous bisphosphonates

Disqualifiers: Pregnancy, Smoking, Alcohol abuse, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how well dental implants (artificial tooth roots) heal when crowns (replacement teeth) are fitted early at 4 weeks compared to the usual 3 months. The researchers aim to determine if early loading (placing the crown sooner) affects the implant's healing and stability in the jaw. Suitable candidates for this trial include individuals missing a first molar in their lower jaw, who maintain good oral hygiene, and have no serious health issues like uncontrolled diabetes or osteoporosis. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important dental advancements.

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

The trial protocol does not specify whether you need to stop taking your current medications. However, it does exclude people with certain medical conditions and those who have used specific treatments like intravenous bisphosphonates.

What prior data suggests that this dental implant protocol is safe?

Research shows that starting dental implants earlier than usual is generally safe. Studies have found that placing crowns on dental implants about four weeks after insertion can be effective if the implant is positioned correctly and has sufficient bone support. This suggests that implants are typically stable and can withstand chewing stress sooner than traditional methods.

Research also highlights that a technique called PRF, which aids healing, can enhance gum and bone recovery while reducing infection risk. This finding reassures those concerned about complications, indicating that early implant use can be safe and effective.

In summary, whether dental implants are used early or later, they are generally well-tolerated, with few problems reported. This supports the idea that early use is a safe option for patients, provided certain conditions are met. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial for early loading of dental implants because it explores how quickly patients can get back to their normal routines with a fully functional tooth. Unlike conventional methods, where crowns are placed around three months after implant placement, this study looks at the possibility of placing crowns just four weeks post-implant. This approach could significantly reduce the waiting time for patients, offering faster restoration of chewing ability and aesthetics. If successful, this method could revolutionize how quickly patients regain full dental function after an implant.

What evidence suggests that early dental implant loading is effective for tissue healing?

This trial will compare two methods of dental crown placement following implant surgery. Studies have shown that the traditional method of placing a dental crown 3 months after the implant, which participants in Group B will receive, achieves a 96% success rate over at least 3 years. In contrast, participants in Group A will receive the crown earlier, at 4 weeks post-implant. Research indicates that early placement carries about twice the risk of failure compared to the traditional method. While both methods can succeed, the traditional approach generally yields better long-term results. ^{1 5 6 7 8}

Who Is on the Research Team?

Aladdin Alardah, DDS, MS

Principal Investigator

associate professor

Are You a Good Fit for This Trial?

Inclusion Criteria

Willingness to comply with all study requirements.

Partially edentulous in the in mandibular first molar with presence of the mandibular second molar

Patients of ASA I and ASA II group. No relevant medical conditions such as uncontrolled diabetes mellitus, osteoporosis, malignancies, irradiation and blood dyscrasias.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive dental implants with either early loading at 4 weeks or conventional loading at 3 months

3 months

Follow-up

Participants are monitored for changes in marginal bone level using standardized intraoral radiographs

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Dental Implant

How Is the Trial Designed?

Group I: Group B Conventional Loading Experimental Treatment 1 Intervention

Crown placement will occur at 3 months post implant

Group II: Group A Early Loading Experimental Treatment 1 Intervention

Crown placement will occur at 4 weeks post implant

Who Is Running the Clinical Trial?

Loma Linda University

Lead Sponsor

Trials

322

Recruited

267,000+

Published Research Related to This Trial

From 1996 to 2011, there were 28,046 adverse event reports related to dental devices in the MAUDE database, with 53.5% of these reports concerning endosseous implants, highlighting a significant area of concern in dental device safety.

Among the reported adverse events, there were 66 death reports associated with dental devices, although many lacked sufficient information to confirm the circumstances, indicating a need for better reporting and monitoring systems in dental care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The dangers of dental devices as reported in the Food and Drug Administration Manufacturer and User Facility Device Experience Database. Hebballi, NB., Ramoni, R., Kalenderian, E., et al.[2021]

During a study analyzing dental device adverse events from August 1996 to June 1999, 28,555 reports (10.5% of total) were related to dental devices, with the majority involving injuries (64.4%) and a small number of deaths (0.007%).

Endosseous implants were the most frequently reported dental devices, accounting for over 90% of the reports, highlighting the importance of monitoring these devices for safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dental device-associated problems: an analysis of FDA postmarket surveillance data. Fuller, J., Parmentier, C.[2019]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12092919/

Early versus conventional loading for fully guided ...

The obtained results are in line with a recent study with long-term follow-up (3 years minimum) showing 96% survival and success rate with only ...

2.

nature.com

nature.com/articles/srep15995

Clinical efficacy of early loading versus conventional ...

The results from that study demonstrated that immediate loading may impose a higher risk for implant failure compared to conventional loading.

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S0022391319303439

Immediate versus early or conventional loading dental ...

The 10-year results of this study showed that the failure rate for immediately loaded implants was significantly higher than that of the conventional submerged ...

4.

medicaljournalssweden.se

medicaljournalssweden.se/actaodontologica/article/download/42027/47932?inline=1

Efficacy of immediate loading compared to conventional ...

Conclusion: Lower implant survival rates and a decrease in marginal bone level was observed compared to immediate loading with conventional loading. KEYWORDS: ...

5.

mdpi.com

mdpi.com/2077-0383/14/5/1442

Optimizing Implant Placement Timing and Loading ...

Implant success rates varied depending on the criteria used, but all types of placements showed acceptable success rates (83.3–100%). The choice of loading ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT02836964

Early Loading of Dental Implants: A Prospective Study in ...

A phase of research to describe clinical trials that focus on the safety of a drug. They are usually conducted with healthy volunteers, and the ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12385616/

Evaluating the Success of Immediate Implants in the Esthetic ...

PRF promoted soft/hard tissue healing and managed infection effectively, resulting in stable bone and esthetic outcomes at 1-year follow-up ...

8.

sciencedirect.com

sciencedirect.com/science/article/pii/S199179022300185X

Primary stability of implant placement and loading related ...

The purpose of this literature review was to explore the relationship between the factors influencing the implant placement stability and implant design.