Dental ImplantsNCT05283928
Implant Primary Stability and Ridge Dimensional Changes Utilizing the Osseodensification Protocol
A study testing OsseoDensification (OD) protocol and standard drilling (SD) protocol (NobelReplace® Conical) in people with Dental Implants, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Implants
- What is being tested?
- OsseoDensification (OD) protocol and standard drilling (SD) protocol (NobelReplace® Conical)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2022to 4 Mar 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who understand and agree to this study.
- Adequate Oral hygiene
- One or more edentulous spaces, which are 10 weeks or longer after extractions
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77054
About this study
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
- Conditions
- Dental Implants
- Being tested
- OsseoDensification (OD) protocol, standard drilling (SD) protocol (NobelReplace® Conical)
- Keywords
- osseodensification, ridge expansion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| OsseoDensification (OD) protocol | Experimental | Not described Receives: Device: OsseoDensification (OD) protocol |
| standard drilling (SD) protocol | Active comparator | Not described Receives: Device: standard drilling (SD) protocol (NobelReplace® Conical) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Bone Ridge Width at Crest
bone ridge width will be measured using a Caliper
Measured: day of implant surgery
Change in Bone Ridge Width at 5mm Apical From Crest
bone ridge width will be measured using a Caliper
Measured: day of implant surgery
Change in Bone Ridge Width at 10mm Apical From Crest
bone ridge width will be measured using a Caliper
Measured: day of implant surgery
Secondary outcomes (8)
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).
Measured: 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.
Measured: 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
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.
Measured: 3 weeks 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 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.
Measured: 6 weeks 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 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.
Measured: 12 weeks after implant placement
Volume of the Ridge as Assessed by the Cone Beam Computer Tomography (CBCT)
Measured: 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
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.
Measured: 6 months post implantation
Percent Change of Buccal Bone Thickness as Assessed by the Cone Beam Computer Tomography at 5 mm From the Implant Platform
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.
Measured: 6 months post implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start1 Aug 2022
- Primary completion16 Nov 2023
- Study completion4 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dental ImplantsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Each participant served as their own control. Each participant had at least 1 control implant and at least 1 test implant.
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Popi Stylianou, The University of Texas Health Science Center, Houston
- Investigators
- Popi Stylianou, DDS,MS, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05283928
- Sponsor's protocol ID
- HSC-DB-21-0597
- Status last verified
- Nov 2024
- First submitted
- 8 Mar 2022
- Last updated
- 29 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- 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 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implant Primary Stability and Ridge Dimensional Changes Utilizing the Osseodensification Protocol
- ClinicalTrials.gov ID
- NCT05283928
- Acronym / sponsor ID
- HSC-DB-21-0597
- Conditions
- Dental Implants
- Keywords
- osseodensification, ridge expansion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 16 Nov 2023 (actual)
- Study completion
- 4 Mar 2024 (actual)
- First posted
- 17 Mar 2022 (actual)
- Results
- Posted 29 Nov 2024
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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Each participant served as their own control. Each participant had at least 1 control implant and at least 1 test implant.
| Arm | Type | Receives |
|---|---|---|
| OsseoDensification (OD) protocol | Experimental | Device: OsseoDensification (OD) protocol |
| standard drilling (SD) protocol | Active comparator | Device: standard drilling (SD) protocol (NobelReplace® Conical) |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who understand and agree to this study.
- Adequate Oral hygiene
- One or more edentulous spaces, which are 10 weeks or longer after extractions
Key exclusion criteria (7 listed)
- 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.
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 (OD) protocolOsseodensification 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. | Device | OsseoDensification (OD) protocol |
| standard drilling (SD) protocol (NobelReplace® Conical)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. | Device | standard drilling (SD) protocol |
Primary outcome
Change in Bone Ridge Width at Crest
Time frame: day of implant surgery
bone ridge width will be measured using a Caliper
Change in Bone Ridge Width at 5mm Apical From Crest
Time frame: day of implant surgery
bone ridge width will be measured using a Caliper
Change in Bone Ridge Width at 10mm Apical From Crest
Time frame: day of implant surgery
bone ridge width will be measured using a Caliper
8 secondary outcomes
Primary Stability of the Implants as Measured by the Insertion Torque Values
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)
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
Time frame: 3 weeks 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 6 Weeks After Implant Placement
Time frame: 6 weeks 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 12 Weeks After Implant Placement
Time frame: 12 weeks after implant placement
Volume of the Ridge as Assessed by the Cone Beam Computer Tomography (CBCT)
Time frame: 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
Time frame: 6 months post implantation
Percent Change of Buccal Bone Thickness as Assessed by the Cone Beam Computer Tomography at 5 mm From the Implant Platform
Time frame: 6 months post implantation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Popi Stylianou, DDS,MS principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OsseoDensification (OD) protocol and standard drilling (SD) protocol (NobelReplace® Conical) in people with Dental Implants, run by The University of Texas Health Science Center, Houston 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 3 inclusion and 7 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 29 Nov 2024. 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?
Yes. Results are posted in the registry (first posted 29 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Bone Ridge Width at Crest (time frame: day of implant surgery). The study lists 3 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 29 Nov 2024.