Implant Primary Stability and Ridge Dimensional Changes Utilizing the Osseodensification Protocol

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

Study Overview

• Status: Completed
• Conditions: Dental Implants
• Intervention / Treatment: Device: OsseoDensification (OD) protocol; Device: standard drilling (SD) protocol (NobelReplace® Conical)

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77054
      • The University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OsseoDensification (OD) protocol	Device: OsseoDensification (OD) protocol; Osseodensification is a drilling process by which bone is being compacted and auto-grafted in an outwardly expanding direction from the osteotomy. When the osseodensification drills are being rotated in a reversed, non-cutting direction a strong and dense layer of bone is formed along the walls and base of the osteotomy.
Active Comparator: standard drilling (SD) protocol	Device: standard drilling (SD) protocol (NobelReplace® Conical); osteotomy preparation through bone excavation is necessary in implant site development for the placement of dental implants. The process involves a forward cutting process with removal of bone tissue creating appropriate size osteotomy for the dental implant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Bone Ridge Width at Crest	bone ridge width will be measured using a Caliper	day of implant surgery
Change in Bone Ridge Width at 5mm Apical From Crest	bone ridge width will be measured using a Caliper	day of implant surgery
Change in Bone Ridge Width at 10mm Apical From Crest	bone ridge width will be measured using a Caliper	day of implant surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Stability of the Implants as Measured by the Insertion Torque Values	Insertion torque refers to the force used to insert an implant into bone, and it is reported in units of Newton-Centimeters (N-cms).	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)	The Implant Stability Quotient (ISQ) value is a measurement used to assess the stability of dental implants. It is obtained by resonance frequency analysis and ranges from 1 to 100, with higher values indicating greater stability.	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	The Implant Stability Quotient (ISQ) value is a measurement used to assess the stability of dental implants. It is obtained by resonance frequency analysis and ranges from 1 to 100, with higher values indicating greater stability.	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	The Implant Stability Quotient (ISQ) value is a measurement used to assess the stability of dental implants. It is obtained by resonance frequency analysis and ranges from 1 to 100, with higher values indicating greater stability.	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	The Implant Stability Quotient (ISQ) value is a measurement used to assess the stability of dental implants. It is obtained by resonance frequency analysis and ranges from 1 to 100, with higher values indicating greater stability.	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	The buccal bone thickness (BBT) was measured using cone beam computed tomography (CBCT). The percentage change in BBT was calculated by comparing the post-implant measurements to baseline values, with positive percentages indicating an increase in thickness and negative percentages indicating a decrease in thickness.	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	The buccal bone thickness (BBT) was measured using cone beam computed tomography (CBCT). The percentage change in BBT was calculated by comparing the post-implant measurements to baseline values, with positive percentages indicating an increase in thickness and negative percentages indicating a decrease in thickness.	6 months post implantation

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Popi Stylianou, DDS,MS, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Actual): November 16, 2023
• Study Completion (Actual): March 4, 2024

Study Registration Dates

• First Submitted: March 8, 2022
• First Submitted That Met QC Criteria: March 8, 2022
• First Posted (Actual): March 17, 2022

Study Record Updates

• Last Update Posted (Actual): November 29, 2024
• Last Update Submitted That Met QC Criteria: November 21, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: osseodensification; ridge expansion
• Other Study ID Numbers: HSC-DB-21-0597

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No