What side effects are associated with this type of intervention?

The most common treatments for tooth loss, such as dental implant placement and bone augmentation, can have several side effects. These include infection at the implant site, injury or damage to surrounding structures such as other teeth or blood vessels, nerve damage that can cause pain, numbness, or tingling in natural teeth, gums, lips, or chin, and sinus problems when implants placed in the upper jaw protrude into the sinus cavities. Additionally, bone augmentation procedures can lead to complications such as graft rejection, prolonged swelling, and discomfort at the graft site.

What prior FDA approvals exist?

The FDA has approved various treatments for tooth loss, particularly focusing on dental implants and bone augmentation techniques. Dental implants, such as titanium posts, are commonly used to replace missing teeth and are often accompanied by bone grafting procedures to ensure adequate bone support. Bone augmentation materials, including autografts, allografts, and synthetic bone substitutes, have also received FDA approval to enhance the success of dental implants. These treatments aim to restore dental function and aesthetics by providing a stable foundation for implant placement.

What other types of research exist?

Promising novel alternatives to traditional surgical techniques for dental implant placement and bone augmentation include the use of stem cell therapy for bone regeneration, 3D printing of custom implants and bone grafts, and the application of growth factors such as recombinant human bone morphogenetic protein-2 (rhBMP-2). Additionally, advancements in laser therapy and minimally invasive procedures are also being explored to enhance outcomes and reduce recovery times for tooth loss patients.

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Dental Implant Techniques for Tooth Loss

N/A

Waitlist Available

Led By Haider Alramli, DDS

Research Sponsored by Nova Southeastern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Absence of active periodontal disease.

Single tooth replacement is needed with simultaneous contour augmentation.

Must not have

Multiple missing teeth adjacent to each other (long span edentulous area).

Active infection at the site of surgery (teeth involved).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 months

Awards & highlights

Summary

This trial is testing two methods for placing dental implants with added bone. It targets patients who need both a dental implant and extra bone support. The study compares different methods to see which one results in better healing after a few months.

Who is the study for?

This trial is for adults over 21 who need a single tooth replaced and bone shaping, have no active gum disease, can come back for check-ups over 4 months, had a tooth taken out at least 8 weeks ago, and are generally healthy. Smokers of more than 10 cigarettes a day or pregnant individuals cannot join.

What is being tested?

The study compares two ways to put in dental implants with bone augmentation: the Transmucosal Technique (non-submerged) versus the Submerged Technique. It's random which method patients get.

What are the potential side effects?

Potential side effects may include discomfort at the implant site, swelling, bruising, infection risk increase around the implant area, and possible issues with how well the implant takes hold.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I do not have active gum disease.

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I need a single tooth replaced and the area around it reshaped.

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I am over 21 and in good or fair health.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have several missing teeth next to each other.

Select...

I have an active infection in my mouth.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Hard tissue healing around dental implants

Secondary study objectives

Soft tissue healing around dental implants

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Transmucosal (Non-Submerged)Experimental Treatment1 Intervention

Flaps will be adapted to the healing abutments for a trans-mucosal healing up on closure

Group II: SubmergedActive Control1 Intervention

Flaps will be advanced to achieve primary wound closure.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Transmucosal Technique

2020

N/A

~30

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Dental implant placement and bone augmentation are common treatments for tooth loss. Dental implants involve surgically inserting a titanium post into the jawbone, which acts as an artificial tooth root. Over time, the bone integrates with the implant through a process called osseointegration, providing a stable foundation for a prosthetic tooth. Bone augmentation, often performed simultaneously, involves adding bone grafts to areas with insufficient bone mass to support the implant. This is crucial for patients with tooth loss as it ensures the stability and longevity of the implant, improves oral function, and enhances aesthetic outcomes.

Biological factors involved in alveolar bone regeneration: Consensus report of Working Group 1 of the 15th European Workshop on Periodontology on Bone Regeneration.Periodontal regeneration - furcation defects: a systematic review from the AAP Regeneration Workshop.Emerging regenerative approaches for periodontal reconstruction: a systematic review from the AAP Regeneration Workshop.