12 Participants Needed

Microbial Sampling for Gum Disease

GP
EP
Overseen ByElysha Pomerantz, DMD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how the tiny organisms in the mouth change when individuals with severe gum disease transition from having some teeth to no teeth and then receive dental implants. It compares different implant types to assess their impact on these changes. Individuals with advanced gum disease who need all their teeth replaced by implants might be suitable candidates. As an unphased trial, this study offers participants the chance to contribute to pioneering research in dental health.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on antibiotics, steroids, or investigational drugs, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that Intra-Lock Fusion Implants are safe and well-tolerated. They are designed to ensure a successful dental implant procedure. The FDA has approved these implants for both single and multiple tooth replacements, confirming they meet specific safety standards.

Research on Tapered Pro Implants also indicates safety. Part of the BioHorizons system, these implants are designed for placement in the jawbone. They have demonstrated safety comparable to other products, suggesting reliability.

Overall, both Intra-Lock Fusion and Tapered Pro Implants prioritize safety, with no major safety concerns reported in the available data.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how dental implants, specifically Intra-Lock Fusion Implants and Tapered Pro Implants, impact oral microbial status. Unlike standard dentures or bridges that don't integrate with the bone, these implants are designed to fuse directly with the jawbone, potentially providing a more stable and long-lasting solution. This trial seeks to understand whether these specific implants can lead to healthier microbial environments in the mouth, compared to edentulous or natural tooth conditions. By studying these changes, researchers hope to uncover insights into improving oral health and longevity of dental implants.

What evidence suggests that this trial's implant treatments could be effective for severe periodontitis?

In this trial, participants will receive either Intra-Lock Fusion Implants or Tapered Pro Implants. Research has shown that Intra-Lock Fusion Implants are highly reliable, achieving a 100% success rate over five years for straight placements and 98.44% for angled placements. These implants effectively support the replacement of one or more teeth and integrate well with the jawbone.

For participants receiving Tapered Pro Implants, data indicates a high success rate, with 97.8% lasting five years. They help maintain bone stability around the implant over time. Additionally, a five-year study found a 99.2% success rate, underscoring their reliability for dental work.12678

Who Is on the Research Team?

GP

Gian Pietro Schincaglia, DDS,PhD

Principal Investigator

Case Western Reserve University

Are You a Good Fit for This Trial?

Inclusion Criteria

You have received dental implants in your upper and/or lower jaw.
There are at least 2 implants that can be checked by the doctor.
You do not need any bone strengthening procedures.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 visit
1 visit (in-person)

Baseline and Extractions

Baseline microbial sampling and full mouth extractions are performed. An immediate denture may be delivered.

1 visit
1 visit (in-person)

Diagnostics for Implant Placement

Diagnostics for implant placement including CBCT and provisional denture adjustments.

3-4 months
Multiple visits (in-person)

Implant Placement

Mucosal-oral microbial sampling and implant placement. Implants are submerged for healing.

1 visit
1 visit (in-person)

Follow-up after Implant Placement

Follow-up and suture removal 14 days after implant placement.

2 weeks
1 visit (in-person)

Implant Uncover

Abutments are connected to the implants after a second stage uncover surgery.

3-4 months
1 visit (in-person)

Follow-up after Implant Uncover

Follow-up and suture removal 14 days after implant uncover procedure.

2 weeks
1 visit (in-person)

Restorative Connection

Permanent abutments are connected to the implants and microbial samples are collected.

1 visit
1 visit (in-person)

Post-loading Follow-up

6 months post-loading, microbial sampling and clinical assessments are performed.

6 months
1 visit (in-person)

Long-term Follow-up

12 months post-loading, microbial sampling and clinical assessments are performed.

12 months
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Microbial Sampling

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Tapered Pro ImplantsExperimental Treatment1 Intervention
Group II: Intra-Lock Fusion ImplantsExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Case Western Reserve University

Lead Sponsor

Trials
314
Recruited
236,000+

Citations

What Is the Survival Rate of Implants Loaded Immediately ...

The overall 5-year survival rate of the implants was 100% for the axially placed implants and 98.44% for the obliquely placed implants. Implant survival rates ...

2.

intra-lock.com

intra-lock.com/Fusion

Fusion

Fusion implants by Intra-Lock offer a unique combination of features that have been carefully designed to deliver successful dental implant treatment.

A Comparison of Conical and Cylindrical Implants Inserted ...

On the other hand, INTRALOCK implants reported the highest results in the block of 20 PCF density with the cortical sheet but showing a statistical significance ...

Intra-Lock® Dental Implants - accessdata.fda.gov

The implants have been designed to be used in either the mandible or the maxilla and to support removable or fixed prostheses, from single tooth.

The effect of implant design on insertion torque and ...

The use of dental implants to replace missing teeth has become a safe treatment modality over the last four decades (Chuang et al. 2001). De- spite the ...

6.

intra-lock.com

intra-lock.com/

Home Page - INTRA-LOCK

Fusion implants offer novel technologies and new workflows with the time-tested design features of Intra-Lock implants.

Intra-Lock System International Dental Implants

Fusion implants, which are built with time-tested design features of Intra-Lock implants, offer novel technologies and new workflows. Spotimplant's Services.

IMPLANT DATABASE - SICAT

Implant One. Standard Implants. Wide Implants. Intra-Lock. Fusion. MDL. MDL 15°. MILO. MILO (Long collar). One-Piece Tapered. IPPON. Screw.