Alveolar Bone LossNCT07160309
Osseodensification and Ridge Expansion for Implant Placement
A study testing Densah Bur and Magnetic Mallet in people with Alveolar Bone Loss, run by Al-Azhar University at 1 site in Egypt.
Trial summary
Ridge expansion techniques allow implant placement in narrow alveolar ridges by increasing bone volume using the native bone. This technique has shown to be a safe and effective procedure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alveolar Bone Loss
- What is being tested?
- Densah Bur and Magnetic Mallet
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2022to 1 Apr 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with partial edentulous alveolar ridges with adequate alveolar bone height and deficient width and density.
- Patients with good state of health and free from systemic or local pathosis that may influence the outcome of the therapy.
- Good oral hygiene.
- Age above 18 years.
- Agreement to participate in the study and also have to be able to attend postoperative clinical and radiological follow-up schedule.
Who cannot join
- Patients with para-functional habits such as bruxism and clenching or abnormal occlusal relationship that may complicate the future restoration.
- Patients with bad oral hygiene or smokers.
- Patients with uncontrolled systemic disease.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry, Department of Oral and Maxillofacial Surgery, Al-Azhar University
Cairo
About this study
Official title: Effect of Densah Bur Versus Magnetic Mallet Device on Osseodensification of Narrow Alveolar Ridge for Implant Placement
Ridge expansion techniques allow implant placement in narrow alveolar ridges by increasing bone volume using the native bone. This technique has shown to be a safe and effective procedure.
Read the detailed description
This clinical study aims to evaluate the effectiveness of ridge expansion techniques in patients with narrow alveolar ridges characterized by low bone density. The procedure relies on using the patient's native bone to increase ridge volume, allowing for successful placement of dental implants without the need for extensive grafting. The study will compare different expansion methods in terms of bone gain, implant stability, and complication rates. By assessing clinical and radiographic outcomes, the trial seeks to determine the predictability and safety of ridge expansion as a minimally invasive alternative for implant site development.
- Conditions
- Alveolar Bone Loss
- Being tested
- Densah Bur, Magnetic Mallet
- Keywords
- Osseodensification Dental Implants
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Densah BurDevice
Implant site preparation will be performed using the Densah bur system to achieve osseodensification in narrow alveolar ridges prior to implant placement.
Magnetic MalletDevice
Implant site preparation will be performed using the Magnetic Mallet device to achieve osseodensification in narrow alveolar ridges prior to implant placement.
| Study group | Role | What they receive |
|---|---|---|
| Densah Bur | Experimental | Participants in this arm will undergo implant site preparation using the Densah bur system for osseo Receives: Device: Densah Bur |
| Magnetic Mallet | Experimental | Participants in this arm will undergo implant site preparation using the Magnetic Mallet device for Receives: Device: Magnetic Mallet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Title: Primary Implant Stability (ISQ Values)
Description: Measurement of implant stability quotient (ISQ) using resonance frequency analysis immediately after implant placement.
Measured: Time Frame: At the time of implant placement (Day 0).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start1 Apr 2022
- Primary completion1 Apr 2024
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Bone LossStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reham Abdelrahman, Al-Azhar University
- Investigators
- Fatma Mohamed, Phd, Principal investigator, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07160309
- Sponsor's protocol ID
- P-SU-22-02
- Status last verified
- Aug 2025
- First submitted
- 15 Aug 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Densah Bur Versus Magnetic Mallet Device on Osseodensification of Narrow Alveolar Ridge for Implant Placement
- ClinicalTrials.gov ID
- NCT07160309
- Acronym / sponsor ID
- P-SU-22-02
- Conditions
- Alveolar Bone Loss
- Keywords
- Osseodensification Dental Implants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 8 Sep 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.
Ridge expansion techniques allow implant placement in narrow alveolar ridges by increasing bone volume using the native bone. This technique has shown to be a safe and effective procedure.
Detailed description
This clinical study aims to evaluate the effectiveness of ridge expansion techniques in patients with narrow alveolar ridges characterized by low bone density. The procedure relies on using the patient's native bone to increase ridge volume, allowing for successful placement of dental implants without the need for extensive grafting. The study will compare different expansion methods in terms of bone gain, implant stability, and complication rates. By assessing clinical and radiographic outcomes, the trial seeks to determine the predictability and safety of ridge expansion as a minimally invasive alternative for implant site development.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Densah Bur | Experimental | Device: Densah BurParticipants in this arm will undergo implant site preparation using the Densah bur system for osseo |
| Magnetic Mallet | Experimental | Device: Magnetic MalletParticipants in this arm will undergo implant site preparation using the Magnetic Mallet device for |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with partial edentulous alveolar ridges with adequate alveolar bone height and deficient width and density.
- Patients with good state of health and free from systemic or local pathosis that may influence the outcome of the therapy.
- Good oral hygiene.
- Age above 18 years.
- Agreement to participate in the study and also have to be able to attend postoperative clinical and radiological follow-up schedule.
Key exclusion criteria (3 listed)
- Patients with para-functional habits such as bruxism and clenching or abnormal occlusal relationship that may complicate the future restoration.
- Patients with bad oral hygiene or smokers.
- Patients with uncontrolled systemic disease.
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 |
|---|---|---|
| Densah BurImplant site preparation will be performed using the Densah bur system to achieve osseodensification in narrow alveolar ridges prior to implant placement. | Device | Densah Bur |
| Magnetic MalletImplant site preparation will be performed using the Magnetic Mallet device to achieve osseodensification in narrow alveolar ridges prior to implant placement. | Device | Magnetic Mallet |
Primary outcome
Title: Primary Implant Stability (ISQ Values)
Time frame: Time Frame: At the time of implant placement (Day 0).
Description: Measurement of implant stability quotient (ISQ) using resonance frequency analysis immediately after implant placement.
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 8 Sep 2025.
- Individual participant dataSharing planned: No
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Diagnostic Accuracy of Large Language Models for Peri-Implant Marginal Bone Loss on Panoramic Radiographs
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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.
Fatma Mohamed, Phd principal investigator
Al-Azhar 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 Densah Bur and Magnetic Mallet in people with Alveolar Bone Loss, run by Al-Azhar University 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 8 Sep 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?
Title: Primary Implant Stability (ISQ Values) (time frame: Time Frame: At the time of implant placement (Day 0).). 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 8 Sep 2025.