What side effects are associated with this type of intervention?

The most common treatments for dental implants, particularly those involving drilling protocols for bone preparation, can have several side effects. These include pain, swelling, and bruising at the implant site, as well as potential infection. There is also a risk of nerve damage, which can lead to numbness or tingling in the lips, gums, or chin. In some cases, patients may experience implant failure if the bone does not integrate properly with the implant. Additionally, improper drilling techniques can lead to bone loss or damage to surrounding structures.

What prior FDA approvals exist?

The FDA has approved various treatments and protocols for dental implants, focusing on enhancing bone preparation and implant stability. One notable approach is the use of osseodensification, a technique that compacts bone during drilling to improve implant stability and reduce ridge dimensional changes. While specific drugs for this purpose are not highlighted, the emphasis remains on procedural innovations and materials that support successful implant integration and longevity.

What other types of research exist?

A promising novel alternative to traditional drilling protocols for dental implant placement is the Osseodensification protocol. This technique enhances primary and secondary stability of implants by preserving bone density and improving ridge dimensional changes compared to standard drilling methods.

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Procedure

Osseodensification Drilling for Dental Implant Stability

N/A

Waitlist Available

Led By Popi Stylianou, DDS,MS

Research Sponsored by The University of Texas Health Science Center, Houston

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Must not have

Patient with malignant tumor

Patients with a history of chemotherapy or radiation in the last 12 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months post implantation

Awards & highlights

No Placebo-Only Group

Summary

This trial is comparing two methods for preparing bone for dental implants: one that compacts the bone and one that removes bone. The goal is to see which method results in better implant stability and less bone loss in patients needing dental implants.

Who is the study for?

This trial is for individuals with good oral hygiene and one or more toothless gaps older than 10 weeks, who understand and agree to participate in the study. Smokers of over 5 cigarettes a day, recent chemotherapy or radiation patients, pregnant women, steroid users, those with uncontrolled hypertension or diabetes, and people with a history of alcoholism or drug abuse within the last 5 years cannot join.

What is being tested?

The study aims to compare two methods used during dental implant surgery: OsseoDensification (OD) protocol versus standard drilling (SD) protocol. It will assess changes in gum ridge dimensions as well as how stable the implants are initially and over time after placement.

What are the potential side effects?

While specific side effects are not listed for this trial, common risks associated with dental implant procedures include infection at the implant site, injury to surrounding structures such as teeth or blood vessels, nerve damage which can result in pain or numbness, sinus problems when upper jaw implants protrude into sinus cavities.

Eligibility Criteria

Exclusion Criteria

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

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I have a cancerous tumor.

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I have had chemotherapy or radiation within the last year.

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I have uncontrolled high blood pressure or diabetes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months post implantation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months post implantation

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months post implantation for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in Bone Ridge Width at 10mm Apical From Crest

Change in Bone Ridge Width at 5mm Apical From Crest

Change in Bone Ridge Width at Crest

Secondary study objectives

Percent Change of Buccal Bone Thickness as Assessed by the Cone Beam Computer Tomography at 1.5 mm From the Implant Platform

Percent Change of Buccal Bone Thickness as Assessed by the Cone Beam Computer Tomography at 5 mm From the Implant Platform

Primary Stability of the Implants as Indicated by the Implant Stability Quotient (ISQ) as Measured by the Resonance Frequency Analysis Using the Ostell ISQ Meter 12 Weeks After Implant Placement

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: OsseoDensification (OD) protocolExperimental Treatment1 Intervention

Group II: standard drilling (SD) protocolActive Control1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

OsseoDensification (OD) protocol

2022

N/A

~20

0 / 3Eligibility 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 treatments commonly involve two primary bone preparation protocols: standard drilling and osseodensification. Standard drilling removes bone to create space for the implant, which can sometimes compromise bone density and stability. In contrast, osseodensification compacts and preserves bone tissue while creating the implant site, enhancing primary stability and potentially improving long-term outcomes. This matters for dental implant patients because better initial stability can lead to faster healing and higher success rates, reducing the risk of implant failure and the need for additional procedures.

Posterior partially edentulous jaws, planning a rehabilitation with dental implants.