Study Comparing Osseodensification With Standard Drilling (OD/SD)

March 2, 2021 updated by: Salah Huwais, Jackson Implant Surgery

Prospective Study Comparing Standard Extraction Drilling With Osseodensification for Dental Implant Placement

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Our postulated null hypotheses is that 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.

Study Objectives:

A.Perform a prospective clinical study to investigate implant primary stability through measuring insertion torque values (IT) and Implant stability quotient (ISQ) when implants are placed using a standard drilling protocol (subtractive surgical drilling, as recommended by implant manufacturers) compared to osseodensification drilling protocol in a split-mouth design.

B.Implant stability quotient will be measured once the implant is placed (immediate), and at 1, 2, 3, 4, 5, 6, 7, 8, and 12 weeks.

C.To investigate, and analyze these two surgical drilling protocols as function of different implant manufacturers with variations in diameter and length.

D.To further track trends in the use of osseodensification surgical drilling once the patient receives the prosthodontic reconstruction.

E.To share the knowledge generated from this prospective analysis through scientific publications.

Patient selection will focus on the need of implant placement on the right and left equivalent sides of the maxilla/mandible where one side/site will receive implant(s) placed post osseodensification surgical drilling recommended by Densifying reference guide of the Densah Burs manufacturer, and the other side/site will receive implant(s) placed by the control technique, which is subtractive conventional drilling recommended by the specific implant manufacturer.

Written consent will be provided, explained and signed by participating patients.

After Dental Implant procedure, participating patients will be asked to participate in 6-12 weekly follow visits.

Subjects Selection and Study Procedures:

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.

Patient selection will focus on the need of implant placement on the right and left equivalent sides of the maxilla/ mandible where one side/site will receive implant(s) placed by osseodensification surgical drilling, and the other side/site will receive implant(s) placed by the control surgical technique, which is subtractive conventional drilling recommended by the implant manufacturer.

Written consent will be provided, explained and signed by participating patients.

After Dental Implant procedure, participating patients will be asked to participate in 6-12 weekly follow-up visits.

Subjects Selection and Study Procedures:

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.

Patient selection will focus on the need of implant placement on the right and left equivalent sides of the maxilla/mandible where one side/site will receive implant(s) placed by osseodensification surgical drilling according to the manufacturer Densifying Reference Guide, and the other side/site will receive implant(s) placed by the control surgical technique, which is subtractive conventional drilling recommended by the implant manufacturer.

Written consent will be provided, explained and signed by participating patients.

After Dental Implant procedure, participating patients will be asked to participate in 6-12 weekly follow visits.

Study Procedures:

  1. The implants will both be placed in the upper or lower jaw. The type of placement preparation of the first implant will be determined by chance (like flipping a coin) with other preparation for the second implant site. Implant primary stability will be measured initially by measuring insertion torque values utilizing a commercially available and validated clinical torque indicator.
  2. Implant placement procedure will follow the standard of care for both implants for pain management, aftercare and infection control.
  3. During the weekly follow-up visits over 6-12 weeks, we will conduct a non-invasive measurement of Implant secondary stability 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. The standard of care is after confirming implant healing and high secondary stability is to initiate yearly follow up as needed.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
23

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Jackson, Michigan, United States, 49203
        • Salah Huwais, DDS, PLLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

22 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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.
Other Names:
  • Densah Bur
Standard Drilling
Utilizing conventional drilling technique with standard bone drilling techniques.
Device: Osseodensification Densah Bur
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.
Other Names:
  • Densah Bur

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Implant Primary Stability
Time Frame: Day 0
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
Time Frame: 1-16 weeks
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cumulative implant survival rate
Time Frame: 10-16 weeks
Implant Osseointegration success rate
10-16 weeks
Bone Instrumentation effect on different implant geometry
Time Frame: 1-16 weeks
Study, and analyze these two surgical drilling protocols as function of different implant manufacturers with variations in diameter and length.
1-16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jackson Implant Surgery

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Salah Huwais, DDS, Jackson Implant Surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 27, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 20, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 18, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 26, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 3, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 4, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • JacksonImplantS

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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