Early Loading of Dental Implants: A Prospective Study in the Mandibular First Molar Area

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

Trial Summary

What is the purpose of this trial?

This trial is testing special dental implants with a modified surface to see how well they work for people needing a single tooth replacement in the lower back part of their mouth. The special surface helps the implant bond better with the jawbone. The study will evaluate success and stability.

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 data supports the effectiveness of the treatment Dental Implant?

Research shows that dental implants can be effective even in areas where previous implants failed, with studies evaluating their survival and bone health. Additionally, dental implants have been successfully used in patients with different health conditions, such as those with HIV, indicating their broad applicability. ^{1 2 3 4 5}

What safety data exists for dental implants?

Dental implants have been studied for safety, with reports of adverse events (unwanted effects) collected by the FDA. A risk analysis for dental implants has been conducted, assessing potential hazards and their likelihood, and initial studies have shown safety in both animal and early human trials. ^{6 7 8 9 10}

How do dental implants differ from other treatments for missing teeth?

Dental implants are unique because they are surgically placed into the jawbone, allowing them to act as a stable base for artificial teeth. This process, called osseointegration, creates a strong bond between the implant and the bone, providing a durable and long-lasting solution compared to other treatments like dentures or bridges, which do not integrate with the bone. ^{11 12 13 14 15}

Research Team

Aladdin Alardah, DDS, MS

Principal Investigator

associate professor

Eligibility Criteria

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

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

Treatment Details

Interventions

• Dental Implant

Participant Groups

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+

Findings from Research

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]

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]

References

1. China pubmed.ncbi.nlm.nih.gov

[A clinical retrospective analysis of dental implants replaced in previously failed sites]. [2018]

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

Reporting and handling of incomplete outcome data in implant dentistry: A survey of randomized clinical trials. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

Clinical outcomes of dental implants placed in the same region where previous implants failed due to peri-implantitis: a retrospective study. [2021]

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

Surgical treatment of peri-implantitis: 3-year results from a randomized controlled clinical trial. [2018]

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

Longitudinal Study of Dental Implants in HIV-Positive Patients. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Dental device-associated problems: an analysis of FDA postmarket surveillance data. [2019]

7. England 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. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Risk analysis and implants. [2008]

9. England pubmed.ncbi.nlm.nih.gov

An adverse event trigger tool in dentistry: a new methodology for measuring harm in the dental office. [2021]

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

Immediate restoration with ti-unite implants: practice-based evidence compared with animal study outcomes. [2013]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Dental Implant Materials: Current State and Future Perspectives. [2021]

12. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Iatrogenic Damage to the Periodontium Caused by Implants and Implant Treatment Procedures. [2020]

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

Eight to eleven-year follow-up of immediately loaded implants placed in edentulous maxillae with compromised bone volume and poor bone quality: A prospective cohort study. [2020]

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

Immediate nonfunctional loading of single-tooth implants in the anterior maxilla following augmentation with freeze-dried cancellous block allograft: a case series. [2016]

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

Implant reconstruction of the jaws and craniofacial skeleton. [2022]