Implant Primary Stability and Ridge Dimensional Changes Utilizing the Osseodensification Protocol

Not Applicable

Completed

• Conditions: Dental Implants
• Interventions: Device: standard drilling (SD) protocol (NobelReplace® Conical); Device: OsseoDensification (OD) protocol

• Registration Number: NCT05283928
• Lead Sponsor: The University of Texas Health Science Center, Houston

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-08
• Study First Submitted QC: 2022-03-08
• Study First Posted: 2022-03-17
• Study Start: 2022-08-01
• Primary Completion: 2023-11-16
• Study Completion: 2024-03-04
• Results First Submitted: 2024-10-29
• Status Verified: 2024-11
• Results First Submitted QC: 2024-11-21
• Last Update Submitted: 2024-11-21
• Results First Posted: 2024-11-28
• Last Update Posted: 2024-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard drilling (SD) protocol	standard drilling (SD) protocol (NobelReplace® Conical)	-
OsseoDensification (OD) protocol	OsseoDensification (OD) protocol	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Primary Stability of the Implants as Measured by the Insertion Torque Values	day of implant surgery	Insertion torque refers to the force used to insert an implant into bone, and it is reported in units of Newton-Centimeters (N-cms).
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)	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.
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	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.
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	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.
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	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.
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	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.
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	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.

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States