Implant Placement Protocols for Dental Implants

SS
MG
Overseen ByMaria Geisinger, DDS, MS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Alabama at Birmingham
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 explores two methods for placing dental implants to determine which is more accurate and comfortable for patients. The study will compare how well these methods align with pre-surgery plans, their impact on healing and bone health for a year post-implant, and patient comfort after surgery. One method uses a fully guided 3-D printed guide (Fully Guided), while the other employs a pilot drill guide based on digital designs (Pilot Drill Guide). This trial is open to English-speaking patients at the UAB Dental School who need a single dental implant and have healthy neighboring teeth or implants. As an unphased study, it offers patients the chance to contribute to innovative dental research and potentially benefit from improved implant techniques.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these dental implant placement protocols are safe?

Research has shown that fully guided (FG) dental implant surgeries are generally safe and well-tolerated. Studies have found that implants placed using computer-guided techniques achieve a high success rate of about 97%. In trials involving 96 implants, all were placed successfully without failures, underscoring a strong safety record. Additionally, guided implant surgeries can reduce pain and enhance surgical accuracy.

For the pilot drill guide (PDG) method, evidence indicates no major safety differences compared to freehand techniques. While FG methods are typically more precise, PDG remains safe. Both methods are safe, but FG might offer a slight advantage in accuracy.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative protocols for placing dental implants. The Fully Guided (FG) technique uses 3-D printed guides based on digital wax-ups, allowing for precise and predictable placement, which could improve accuracy compared to traditional freehand methods. Meanwhile, the Pilot Drill Guide (PDG) uses matrix-based guides derived from casts of digital wax-ups, offering a tailored approach that integrates initial implant planning with the final restoration design. These advanced methods aim to enhance the efficiency and success rate of dental implant procedures, potentially leading to better outcomes for patients.

What evidence suggests that these implant placement protocols are effective for dental implants?

This trial will compare two implant placement protocols: the Fully Guided (FG) approach and the Pilot Drill Guide (PDG) method. Studies have shown that the FG approach places dental implants more accurately than other methods. Specifically, the FG method has a lower early implant failure rate of 2.25% compared to 6.42% for non-guided techniques, reducing the likelihood of implants becoming loose or failing early. Additionally, FG procedures can lead to higher patient satisfaction due to more precise placement and less discomfort.

In contrast, the PDG method, another treatment arm in this trial, also delivers good results but with slightly less precision than FG. It remains effective, though the accuracy is somewhat lower, with an average deviation of 2.24 mm. Both methods aim to improve implant success and patient comfort, but FG might offer a slight advantage in terms of accuracy and satisfaction.36789

Who Is on the Research Team?

ML

Maria L Geisinger, DDS, MS

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for adults (18+) who need a single dental implant, have healthy teeth or implants next to the site, are patients at UAB Dental School, and can read English. People with certain health issues, heavy smokers, those needing more than one adjacent implant, or non-English speakers can't join.

Inclusion Criteria

I do not need dental or root canal work near the surgery site during the study.
I am at least 18 years old.
I have one area without teeth where I plan to get a dental implant.
See 4 more

Exclusion Criteria

Non-English speaking
I am younger than 18 years old.
I do not have teeth or implants next to the area needing extraction or multiple implants.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo dental implant placement using either fully guided or pilot drill guide protocols

4 weeks
3 visits (in-person)

Follow-up

Participants are monitored for post-operative healing, bone levels, and patient discomfort using VAS

12 months
Monthly visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Fully Guided (FG)
  • Pilot Drill Guide (PDG)

Trial Overview

The study compares two methods for placing dental implants: using a pilot drill guide versus a fully guided surgical protocol. It looks at how accurately each method places the implant and how well patients heal over 12 months.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Fully Guided (FGExperimental Treatment1 Intervention
Group II: Pilot Drill Guide (PDG)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials
1,677
Recruited
2,458,000+

Citations

Guided Dental Implant Surgery: Systematic Review - PMC

The aim of this systematic review is to evaluate survival rates, early and late failure rates, peri-implant bone remodeling, and possible implant-prosthetic ...

Guided Implant Surgery: Evidence, Accuracy & Advantages

A meta‑analysis in BDJ Open reported a pooled early implant failure rate of 6.42% for freehand placement versus 2.25% for guided surgery, ...

Impact of Guided Implant Dentistry on Patient Quality of Life ...

Regarding satisfaction, two studies reported that computer-guided implantology and flapless approaches were associated with greater patient satisfaction and ...

Failure rates associated with guided versus non- ...

Both guided and free-hand implant placement techniques resulted in a high implant survival rate. However, implant failure rates were almost three times higher.

Trueness of fully guided versus partially guided implant ... - PMC

The FG approach resulted in statistically significantly higher overall trueness in entry, apex, and angle deviation across multiple implant ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/36607263/

Accuracy of fully guided dental implant placement

Conclusions: Fully guided implant placements in single-tooth gaps provide accurate results. Due to significant vertical deviations, reevaluation ...

Long-Term Effect of Guided Implant Surgery on Clinical ... - PMC

A systematic review and meta-analysis reported a cumulative survival rate of 83.9% [18] to 100% of the prosthesis after 1–4-years [12]. It is not surprising ...

Survival and Success Rates of Implants Placed with ...

Introduction: The long-term success and survival of dental implants depend a lot on how accurately and precisely they are placed.

Trueness of fully guided versus partially guided implant ...

All 96 implants were successfully placed according to the predetermined plan. Throughout this study, there were no instances of implant failure, ...