Tooth LossOD/SDNCT04779203
Study Comparing Osseodensification With Standard Drilling
An observational study of Tooth Loss, run by Jackson Implant Surgery at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 80 years
- Conditions the study is for
- Tooth Loss
- What is being tested?
- Osseodensification Densah Bur
- Type of treatment
- Medical device
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jul 2020to 18 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 80 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- Patient needs an implant placements in both maxilla and mandible.
- Patients are medically stable.
Who cannot join
- Drug Abuse
- Patient should not have been in any other research study in the last 90 days from the study starting date.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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:
- 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.
- Implant placement procedure will follow the standard of care for both implants for pain management, aftercare and infection control.
- 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.
- Conditions
- Tooth Loss
- Being tested
- Osseodensification Densah Bur
- Keywords
- Osseodensification, Standard Extraction Drilling, Implant Primary stability, Implant Secondary Stability
- Medical subject headings
- Tooth Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osseodensification Densah BurDevice
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Osseodensification Densah Bur | |
| Standard Drilling | Utilizing conventional drilling technique with standard bone drilling techniques. Receives: Device: Osseodensification Densah Bur |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 1-16 weeks
Secondary outcomes (2)
Cumulative implant survival rate
Implant Osseointegration success rate
Measured: 10-16 weeks
Bone Instrumentation effect on different implant geometry
Study, and analyze these two surgical drilling protocols as function of different implant manufacturers with variations in diameter and length.
Measured: 1-16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start27 Jul 2020
- Primary completion20 Nov 2020
- Study completion18 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jackson Implant Surgery
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Salah Huwais, Jackson Implant Surgery
- Investigators
- Salah Huwais, DDS, Principal investigator, Jackson Implant Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04779203
- Sponsor's protocol ID
- JacksonImplantS
- Acronym
- OD/SD
- Status last verified
- Mar 2021
- First submitted
- 26 Feb 2021
- Last updated
- 4 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study Comparing Standard Extraction Drilling With Osseodensification for Dental Implant Placement
- ClinicalTrials.gov ID
- NCT04779203
- Acronym / sponsor ID
- OD/SD / JacksonImplantS
- Conditions
- Tooth Loss
- Keywords
- Osseodensification, Standard Extraction Drilling, Implant Primary stability, Implant Secondary Stability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Jackson Implant SurgeryIndustry (pharma, biotech, devices)
- Study start
- 27 Jul 2020 (actual)
- Primary completion
- 20 Nov 2020 (actual)
- Study completion
- 18 Dec 2020 (actual)
- First posted
- 3 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
- Implant placement procedure will follow the standard of care for both implants for pain management, aftercare and infection control.
- 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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Osseodensification | – | Device: Osseodensification Densah BurOsseodensification 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. |
| Standard Drilling | – | Device: Osseodensification Densah BurUtilizing conventional drilling technique with standard bone drilling techniques. |
Who may qualify
- Ages
- 22 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Patient needs an implant placements in both maxilla and mandible.
- Patients are medically stable.
Key exclusion criteria (2 listed)
- Drug Abuse
- Patient should not have been in any other research study in the last 90 days from the study starting date.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osseodensification Densah BurAlso: Densah BurImplants 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. | Device | Osseodensification, Standard Drilling |
Primary outcome
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)
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.
2 secondary outcomes
Cumulative implant survival rate
Time frame: 10-16 weeks
Bone Instrumentation effect on different implant geometry
Time frame: 1-16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Salah Huwais, DDS principal investigator
Jackson Implant Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tooth Loss, run by Jackson Implant Surgery at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant Primary Stability (time frame: Day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2021.