Implant Primary Stability and Ridge Dimensional Changes Utilizing the Osseodensification Protocol

The University of Texas Health Science Center, Houston1 site in 1 country15 target enrollmentAugust 1, 2022

ConditionsDental Implants

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Dental Implants
Sponsor: The University of Texas Health Science Center, Houston
Enrollment: 15
Locations: 1
Primary Endpoint: Change in Bone Ridge Width at Crest
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to compare ridge dimensional changes between densification and standard drilling protocols and to compare primary and secondary stability of implants placed by bone densification and standard drilling protocols

Registry

clinicaltrials.gov

Start Date

August 1, 2022

End Date

March 4, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

The University of Texas Health Science Center, Houston

Responsible Party

Principal Investigator

Popi Stylianou

Clinical Associate Professor

The University of Texas Health Science Center, Houston

Eligibility Criteria

Inclusion Criteria

•Patients who understand and agree to this study.
•Adequate Oral hygiene
•One or more edentulous spaces, which are 10 weeks or longer after extractions

Exclusion Criteria

•Pregnancy.
•Smoking of more than 5 cigarettes/day.
•History of alcoholism or drug abuse during the last 5 years.
•Uncontrolled Hypertension or diabetes.
•Patient with malignant tumor.
•Patients on daily dose of steroids.
•Patients with history of chemotherapy or radiation for the last 12 months.

Outcomes

Primary Outcomes

Change in Bone Ridge Width at Crest

Time Frame: day of implant surgery

bone ridge width will be measured using a Caliper

Change in Bone Ridge Width at 5mm Apical From Crest

Time Frame: day of implant surgery

bone ridge width will be measured using a Caliper

Change in Bone Ridge Width at 10mm Apical From Crest

Time Frame: day of implant surgery

bone ridge width will be measured using a Caliper

Secondary Outcomes

Primary Stability of the Implants as Measured by the Insertion Torque Values(day of implant surgery)
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 Baseline(After Implant Placement)(baseline(after implant placement))
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 3 Weeks After Implant Placement(3 weeks after implant placement)
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 6 Weeks After Implant Placement(6 weeks after implant placement)
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(12 weeks after implant placement)
Volume of the Ridge as Assessed by the Cone Beam Computer Tomography (CBCT)(6 months post implantation)
Percent Change of Buccal Bone Thickness as Assessed by the Cone Beam Computer Tomography at 1.5 mm From the Implant Platform(6 months post implantation)
Percent Change of Buccal Bone Thickness as Assessed by the Cone Beam Computer Tomography at 5 mm From the Implant Platform(6 months post implantation)