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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months post implantation
Awards & highlights
Study Summary
This trial is comparing how different protocols for drilling and densifying bone affects the overall stability of an implanted tooth.
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.Check my eligibility
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.See study design
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months post implantation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months post implantation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
Change in 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
Primary stability of the implants as measured by the insertion torque values
buccolingual width of the ridge as assessed by the Cone beam computer tomography (CBCT)
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: OsseoDensification (OD) protocolExperimental Treatment1 Intervention
Group II: standard drilling (SD) protocolActive Control1 Intervention
Find a Location
Who is running the clinical trial?
The University of Texas Health Science Center, HoustonLead Sponsor
903 Previous Clinical Trials
320,957 Total Patients Enrolled
1 Trials studying Dental Implants
46 Patients Enrolled for Dental Implants
Popi Stylianou, DDS,MSPrincipal InvestigatorThe University of Texas Health Science Center, Houston
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a cancerous tumor.I have one or more gaps from missing teeth for at least 10 weeks.I have had chemotherapy or radiation within the last year.I am taking steroids every day.I maintain good oral hygiene.I have uncontrolled high blood pressure or diabetes.I maintain good oral hygiene.I have one or more gaps from missing teeth for at least 10 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: standard drilling (SD) protocol
- Group 2: OsseoDensification (OD) protocol
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Dental Implants Patient Testimony for trial: Trial Name: NCT05283928 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there still opportunity for enrolment in this research program?
"As reported on clinicaltrials.gov, enrolment for this medical trial is still ongoing since its initial publication date of August 1st 2022 and last edit dated November 16th 2022."
Answered by AI
What is the cap on enrolment in this medical experiment?
"Affirmative. The information posted on clinicaltrials.gov reveals that the trial is presently enrolling participants, having first been shared on August 1st 2022 and updated most recently on November 16th of the same year. Presently, 20 patients are needed from a single medical centre for this study's completion."
Answered by AI
Who else is applying?
What state do they live in?
Oklahoma
Nevada
Other
Texas
How old are they?
18 - 65
What site did they apply to?
The University of Texas Health Science Center at Houston
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
3+
0
Why did patients apply to this trial?
Teeth getting worse. I have missing teeth. I have ran out of options in life.
PatientReceived no prior treatments
I have been delaying the removal of a. Need implants and need to build bone I think.
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
When will I know if I am selected? What types of implants will you do?
PatientReceived 2+ prior treatments
How responsive is this trial?
Most responsive sites:
- The University of Texas Health Science Center at Houston: < 48 hours
Average response time
- < 2 Days
Typically responds via
Phone Call
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