Implant Primary Stability and Ridge Dimensional Changes Utilizing the Osseodensification Protocol

The University of Texas Health Science Center, Houston15 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Dental Implants

Interventions

OsseoDensification (OD) protocolDEVICE

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.

standard drilling (SD) protocol (NobelReplace® Conical)DEVICE

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.

Eligibility

Sex: ALLMin age: 22 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Outcomes

Primary Outcomes

Change in Bone Ridge Width at Crest

bone ridge width will be measured using a Caliper

Time frame: day of implant surgery

Change in Bone Ridge Width at 5mm Apical From Crest

bone ridge width will be measured using a Caliper

Time frame: day of implant surgery

Change in Bone Ridge Width at 10mm Apical From Crest

bone ridge width will be measured using a Caliper

Time frame: day of implant surgery

Secondary Outcomes

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).

Time frame: 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.

Time frame: 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

Data from ClinicalTrials.gov

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