Study Comparing Osseodensification With Standard Drilling

NCT04779203 | Completed FDA Device

• 1 other identifier: JacksonImplantS
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine how Osseodensification, a well-defined bone preparation procedure utilizing special densifying burs (a tool to prepare bone) compares to the standard drilling procedure utilizing regular bone drills, to possibly enhance dental implant healing.

Conditions

Tooth Loss

Keywords

Osseodensification, Standard Extraction Drilling; Implant Primary stability, Implant Secondary Stability

Outcome Measures

Primary Outcomes (2)

• Implant Primary Stability

  Implant primary stability is a mechanical parameters that reflects implant stability Day of surgery. Implant primary stability is measured by measuring implant insertion torque (measured during implant insertion with a torque wrench)

  Day 0

• Implant Secondary Stability

  During the weekly follow-up visits over 1-12 weeks, we will conduct a non-invasive measurement of implant secondary stability (correlated to BIC) utilizing the Osstell device. Osstell is a resonance frequency tester, which will create a gentle vibration in the implant and measure how much if any the implant moves with the vibration. The device will not loosen the implant. We will measure weekly. The standard of care is measurement of implant stability at 6-12 weeks post implant placement with yearly follow up as needed.

  1-16 weeks

Secondary Outcomes (2)

• Cumulative implant survival rate

  10-16 weeks

• Bone Instrumentation effect on different implant geometry

  1-16 weeks

Study Arms (2)

Osseodensification

Osseodensification is a novel, biomechanical osteotomy preparation technique that preserves bone through a non-excavating drilling process utilizing specially designed burs with a tapered geometry and specially designed flutes progressively expand the osteotomy whilst compacting bone into its walls and apex.

Device: Osseodensification Densah Bur

Standard Drilling

Utilizing conventional drilling technique with standard bone drilling techniques.

Device: Osseodensification Densah Bur

Interventions

Osseodensification Densah Bur DEVICE

Implants placed with osseodensification surgical drilling compared to those placed with subtractive conventional drilling technique in a split-mouth design will result: 1) in the same insertion torque values and; 2) in the same implant stability quotient values when measured immediately after implant placement and after 1, 2, 3, 4, 5, 6, 7, 8, and 12 weeks.

Also known as: Densah Bur

Osseodensification; Standard Drilling

Eligibility Criteria

• Age: 22 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study will include 23 patients. Patients should not be in another research study or have not been in any other research study in the last 90 days. They cannot be in this study if they are abusing any drugs. Patients are older than 22 years, medically Stable Patients should not be in another research study or have not been in any other research study in the last 90 days.

You may qualify if:

• Patient needs an implant placements in both maxilla and mandible.
• Patients are medically stable.

You may not qualify if:

• Drug Abuse
• Patient should not have been in any other research study in the last 90 days from the study starting date.

Sponsors & Collaborators

• Jackson Implant Surgery: lead

Study Sites (1)

Salah Huwais, DDS, PLLC

Jackson, Michigan, 49203, United States

Location

MeSH Terms

Conditions

Tooth Loss

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Study Officials

• Salah Huwais, DDS

  Jackson Implant Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 26, 2021
• First Posted: March 3, 2021
• Study Start: July 27, 2020
• Primary Completion: November 20, 2020
• Study Completion: December 18, 2020
• Last Updated: March 4, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)