OsseodensificationNCT07061015
Efficacy of Different Osseodensification Techniques
A study testing osseodenification with osseodensifying burs, reverse drilling and rotary expanders in people with Osseodensification, run by Delta University for Science and Technology at 1 site in Egypt.
Trial summary
different possible osseodensification techniques used to improve bone density around dental implants, using either ] osseodensifying drills, reverse drilling of conventional drills, and rotary expanders. Read more about this study
- Who is it for?
- Ages 45 to 60 years, women only
- Conditions the study is for
- Osseodensification
- What is being tested?
- osseodenification with osseodensifying burs, reverse drilling and rotary expanders
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2023to 15 Jan 2025
- Phase
- Interventional
- 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 45 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- · Adult osteoporotic female patients confirmed by CBCT grey values ranging from 290 to 420 HU, with age range 45-60 years.
- Patients should be free from any other systemic diseases, according to ASA classifications (American society of Anesthesiologists).
- Patients of single or multiple missing teeth in the posterior mandible.
- A ridge width of 4mm and a height of > 8mm above the roof of Inferior Alveolar canal.
- No buccal concavities were present at the planned implant site
Who cannot join
- · Poor oral hygiene.
- Heavy smoker (more than 20 cigarettes /day),or alcoholic abusing patients.
- Radiation therapy to the head and neck region, or chemotherapy in the last 6 months prior to the implant placement.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Delta university for science and technology
Al Mansurah, Daqhlia, 35515
About this study
Official title: Evaluation Of Different Motor Driven Osseodensification Techniques Used For Implant Placement In Posteriorly Atrophied Mandible Of Osteoporotic Patients
different possible osseodensification techniques used to improve bone density around dental implants, using either ] osseodensifying drills, reverse drilling of conventional drills, and rotary expanders.
Read the detailed description
the study include 3 groups with different implant drilling protocols; group 1 where osseodensifying burs are used, group 2 where conventional drills with reverse motion are used, group 3 where rotary expanders are used
- Conditions
- Osseodensification
- Being tested
- osseodenification with osseodensifying burs, reverse drilling, rotary expanders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
osseodenification with osseodensifying bursProcedure or surgery
different osseodensification techniques to be studied
reverse drillingProcedure or surgery
using the conventional drills in reverse mode
rotary expandersProcedure or surgery
expanders in clockwise direction
| Study group | Role | What they receive |
|---|---|---|
| osseodensifying burs | Active comparator | osseodensifying burs are used in reverse motion . Receives: Procedure: osseodenification with osseodensifying burs |
| reverse drilling | Active comparator | using conventional implant drills in reverse motion(anti clock wise) Receives: Procedure: reverse drilling |
| rotary expanders | Active comparator | using rotary expanders in clock wise motion Receives: Procedure: rotary expanders |
What is being measured
The primary outcome is the main question the study is designed to answer.
peri implant bone density
through ROI (region of interest) to measure Grey scale on Cone beam computed tomography CBCT
Measured: 12 months
implant stability quotient
ISQ (implant stability quotient) using osstell device
Measured: 12 months
alveolar ridge dimension changes
with cone beam computed tomography CBCT in coronal and sagittal cuts, in millimeters mm .
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start1 Mar 2023
- Primary completion10 Sep 2024
- Study completion15 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsseodensificationStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Delta University for Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Mansoura University
- Responsible party
- Sponsor
- Investigators
- Mohammed MZ M Zaghlol Amer, Professor, Study director, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07061015
- Sponsor's protocol ID
- A01030123
- Status last verified
- Jun 2025
- First submitted
- 22 Jun 2025
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of Different Motor Driven Osseodensification Techniques Used For Implant Placement In Posteriorly Atrophied Mandible Of Osteoporotic Patients
- ClinicalTrials.gov ID
- NCT07061015
- Acronym / sponsor ID
- A01030123
- Conditions
- Osseodensification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Delta University for Science and TechnologyUniversity, hospital or other
- Collaborators
- Mansoura University
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 10 Sep 2024 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 11 Jul 2025 (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.
different possible osseodensification techniques used to improve bone density around dental implants, using either ] osseodensifying drills, reverse drilling of conventional drills, and rotary expanders.
Detailed description
the study include 3 groups with different implant drilling protocols; group 1 where osseodensifying burs are used, group 2 where conventional drills with reverse motion are used, group 3 where rotary expanders are used
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| osseodensifying burs | Active comparator | Procedure: osseodenification with osseodensifying bursosseodensifying burs are used in reverse motion . |
| reverse drilling | Active comparator | Procedure: reverse drillingusing conventional implant drills in reverse motion(anti clock wise) |
| rotary expanders | Active comparator | Procedure: rotary expandersusing rotary expanders in clock wise motion |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- · Adult osteoporotic female patients confirmed by CBCT grey values ranging from 290 to 420 HU, with age range 45-60 years.
Key exclusion criteria (3 listed)
- · Poor oral hygiene.
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 |
|---|---|---|
| osseodenification with osseodensifying bursdifferent osseodensification techniques to be studied | Procedure or surgery | osseodensifying burs |
| reverse drillingusing the conventional drills in reverse mode | Procedure or surgery | reverse drilling |
| rotary expandersexpanders in clockwise direction | Procedure or surgery | rotary expanders |
Primary outcome
peri implant bone density
Time frame: 12 months
through ROI (region of interest) to measure Grey scale on Cone beam computed tomography CBCT
implant stability quotient
Time frame: 12 months
ISQ (implant stability quotient) using osstell device
alveolar ridge dimension changes
Time frame: 12 months
with cone beam computed tomography CBCT in coronal and sagittal cuts, in millimeters mm .
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 11 Jul 2025.
Related trials for Osseodensification
Recruiting
"Osseodensification Efficacy on Molar Septum Expansion in Immediate Molar Implant Placement
Implant Osseointegration, Implant Osteotomy
Recruiting
Two-Stage Transcrestal Sinus Lift With Osseodensification: Allograft vs Autogenous-Xenograft
Severely Atrophic Posterior Maxilla
Active, not recruiting
Osseodensification for Narrow Alveolar Ridge Expansion
Osseodensification, Bone Expansion
Enrolling by invitation
Implant Stability Outcomes Following Immediate Implant Placement Using Osseodensification Versus Conventional Drilling
Immediate Dental Implant Placement, Lower Molar Requiring Extraction
Not yet recruiting
Clinical, Radiographic, Histological, and Patient-reported/ Experience Outcome Measures of Endoscopically-monitored Graftless Transcrestal Sinus Floor Elevation With Simultaneous Multiple Implant Placement Using Osseodensification(OD) Versus Osteotomes (OT) in Subsinus Bone Height of 4-5 mm: An RCT
Osseodensification Drilling Technique
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.
Mohammed MZ M Zaghlol Amer, Professor study director
Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing osseodenification with osseodensifying burs, reverse drilling and rotary expanders in people with Osseodensification, run by Delta University for Science and Technology at 1 site in Egypt.
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 5 inclusion and 3 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 11 Jul 2025. 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 Egypt. 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?
peri implant bone density (time frame: 12 months). 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 11 Jul 2025.