Clinical trial NCT05283928: Implant Primary Stability and Ridge Dimensional Changes Utilizing the Osseodensification Protocol
Official title: Implant Primary Stability and Ridge Dimensional Changes Utilizing the Osseodensification Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Implants
Keywords: osseodensification
ridge expansion
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2022-03-17
Enrollment: 15
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Each participant served as their own control. Each participant had at least 1 control implant and at least 1 test implant.
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Change in Bone Ridge Width at Crest
timeFrame: day of implant surgery
measure: Change in Bone Ridge Width at 5mm Apical From Crest
timeFrame: day of implant surgery
measure: Change in Bone Ridge Width at 10mm Apical From Crest
timeFrame: day of implant surgery
Secondary outcomes:
measure: Primary Stability of the Implants as Measured by the Insertion Torque Values
timeFrame: day of implant surgery
measure: 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)
timeFrame: baseline(after implant placement)
measure: 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
timeFrame: 3 weeks after implant placement
measure: 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
timeFrame: 6 weeks after implant placement
measure: 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
timeFrame: 12 weeks after implant placement
measure: Volume of the Ridge as Assessed by the Cone Beam Computer Tomography (CBCT)
timeFrame: 6 months post implantation
measure: Percent Change of Buccal Bone Thickness as Assessed by the Cone Beam Computer Tomography at 1.5 mm From the Implant Platform
timeFrame: 6 months post implantation
measure: Percent Change of Buccal Bone Thickness as Assessed by the Cone Beam Computer Tomography at 5 mm From the Implant Platform
timeFrame: 6 months post implantation
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Popi Stylianou, DDS,MS
role: PRINCIPAL_INVESTIGATOR
References: