Dental ImplantNCT07066930
Optimizing Alveolar Ridge Expansion
A study testing Magneto-Dynamic Ridge Expansion and Osseodensification with Versah Drills in people with Dental Implant, run by Hawler Medical University at 1 site in Iraq.
Trial summary
The goal of this clinical trial is to compare two surgical techniques-Magneto-Dynamic Ridge Splitting and Versah Osseodensification-for expanding narrow alveolar ridges in adults requiring dental implant placement. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Dental Implant
- What is being tested?
- Magneto-Dynamic Ridge Expansion and Osseodensification with Versah Drills
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIraq
- Study dates
- 1 Aug 2025to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 to 70 years.
- Partially edentulous patients requiring ridge expansion prior to dental implant placement.
- Alveolar ridge width between 4 mm and 6 mm as measured on CBCT.
- Sufficient vertical bone height for implant placement without the need for vertical augmentation.
- Adequate oral hygiene and commitment to postoperative care and follow-up visits.
- Signed informed consent form.
Who cannot join
- Presence of systemic conditions contraindicating oral surgery (e.g., uncontrolled diabetes, immune-compromised status).
- History of bisphosphonate therapy or radiation therapy to the head and neck region.
- Active periodontal disease or untreated oral infections.
- Heavy smokers (more than 10 cigarettes per day).
- Pregnant or breastfeeding women.
- History of substance abuse or psychiatric disorders that could impair compliance with study protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Iraq1 site
Oral and Maxillofacial Surgery Department, College of Dentistry, Hawler Medical University, Erbil, Kurdistan Region, Iraq.
Erbil, 44001
Abduljaleel Azad Samad, PhD, 07504843344, abduljaleel.samad@gmail.com
Jodal Ahmed, Phd, 009647504532506, jodal.ahmed@hmu.edu.krd
About this study
Official title: Optimizing Alveolar Ridge Expansion: A Clinical Comparison of Magneto-Dynamic Ridge Splitting and Versah Osseodensification Techniques
The goal of this clinical trial is to compare two surgical techniques-Magneto-Dynamic Ridge Splitting and Versah Osseodensification-for expanding narrow alveolar ridges in adults requiring dental implant placement. The main questions it aims to answer are:
Which technique better preserves alveolar bone width after surgery?
Read more
Which method results in higher primary implant stability?
Researchers will compare ridge splitting using the Magnetic Mallet to ridge expansion using Versah drills to see if one technique leads to better clinical outcomes, such as improved bone preservation, greater implant stability, and favorable soft tissue response.
Participants will:
Undergo ridge expansion surgery using either the Magnetic Mallet or Versah drills, followed by immediate dental implant placement.
Receive CBCT scans before and 4 months after surgery to measure bone changes.
Undergo implant stability testing using the ISQ (Implant Stability Quotient) method.
Have intraoral scans to evaluate changes in soft tissue volume and thickness.
Read the detailed description
This clinical trial aims to evaluate and compare two innovative techniques used to widen narrow jawbone areas (alveolar ridges) in preparation for dental implants. In many patients, the bone in the jaw may be too thin to support dental implants without additional procedures. Traditionally, this problem has been addressed using more invasive surgical methods that can involve bone grafting and extended healing times.
The two techniques being studied are:
Magneto-Dynamic Ridge Splitting (Magnetic Mallet) - This method uses gentle electromagnetic impulses to gradually split and expand the bone. The technique is minimally traumatic, preserves the outer bone layer (cortical bone), and may promote better healing and stability for implants.
Osseodensification (Versah Drills) - This technique uses specially designed rotating drills (Densah burs) that do not remove bone but instead compact it outward, increasing its density. This approach is designed to strengthen the implant site and improve how well the implant integrates with the bone.
The study is a randomized controlled clinical trial conducted at Hawler Medical University. Participants will be randomly assigned to one of the two groups. Both groups will receive immediate implant placement following the ridge expansion procedure, using the same implant system (ROOTT Implants).
Key outcomes to be measured include:
Changes in bone width (buccolingual ridge dimension) using Cone Beam Computed Tomography (CBCT) before and 4 months after surgery.
Implant Stability Quotient (ISQ) values recorded at the time of implant placement and again during the second-stage surgery using a non-invasive resonance frequency analysis device (Osstell).
Soft tissue changes, such as thickness and volume around the implant site, using intraoral scanning technology.
The trial will also monitor patient comfort, healing, and potential complications in each group. By directly comparing these two methods, the researchers hope to determine which approach provides better clinical outcomes in terms of bone preservation, implant stability, and soft tissue health. The results may help establish a new standard in minimally invasive implant site preparation techniques and guide oral surgeons and implantologists in choosing the most effective ridge expansion strategy for their patients.
This study will be conducted in accordance with ethical standards, and all participants will be asked to provide informed consent prior to joining the trial.
- Conditions
- Dental Implant
- Being tested
- Magneto-Dynamic Ridge Expansion, Osseodensification with Versah Drills
- Keywords
- Ridge expansion, Osseodensification, Magnetic mallet, Dental implants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magneto-Dynamic Ridge ExpansionProcedure or surgery
A ridge expansion technique using the Magnetic Mallet device. Controlled magneto-dynamic impulses are applied to split the alveolar ridge and compact bone prior to immediate implant placement.
Osseodensification with Versah DrillsProcedure or surgery
A ridge expansion method using Versah drills (Densah burs) in osseodensification mode. The drills densify bone without removing it, enhancing bone density and implant stability.
Arm Assignment: Versah Osseodensification (Active Comparator arm)
| Study group | Role | What they receive |
|---|---|---|
| Magneto-Dynamic Ridge Splitting | Experimental | Participants in this arm will undergo ridge expansion using the Magnetic Mallet system. The procedure involves magneto-dynamic impulses to laterally expand the alveolar ridge prior to dental implant placement. Receives: Procedure: Magneto-Dynamic Ridge Expansion |
| Versah Osseodensification | Active comparator | Participants in this arm will undergo ridge expansion using Versah drills (Densah burs) in osseodensification mode prior to dental implant placement. Receives: Procedure: Osseodensification with Versah Drills |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Alveolar Ridge Width (Buccolingual Dimension)
Measurement of alveolar ridge width in millimeters using Cone Beam Computed Tomography (CBCT) to assess the horizontal bone gain after ridge expansion with either the Magneto-Dynamic Ridge Splitting or Versah Osseodensification technique.
Measured: 4 Months
Change in Alveolar Ridge Width (Buccolingual Dimension)
Measurement of alveolar ridge width in millimeters using Cone Beam Computed Tomography (CBCT) to assess the horizontal bone gain after ridge expansion with either the Magneto-Dynamic Ridge Splitting or Versah Osseodensification technique.
Measured: Baseline (pre-operative) and 4 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start1 Aug 2025 (estimated)
- Primary completion1 May 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hawler Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de Granada
- Responsible party
- Principal investigator, Abduljaleel Azad Koyi, Hawler Medical University
- Investigators
- Jodal Ahmed, PhD, Study director, Oral and Maxillofacial Surgery Department, College of Dentistry, Hawler Medical University, Erbil, Kurdistan Region, Iraq.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07066930
- Sponsor's protocol ID
- HMUD2425177
- Status last verified
- Jul 2025
- First submitted
- 4 Jul 2025
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We have not yet determined whether individual participant data (IPD) will be shared with other researchers. The decision will depend on the outcomes of the study, institutional policies, ethical approvals, and potential publication requirements. Any future data sharing will comply with applicable data protection regulations and will require appropriate de-identification and ethical clearance.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Alveolar Ridge Expansion: A Clinical Comparison of Magneto-Dynamic Ridge Splitting and Versah Osseodensification Techniques
- ClinicalTrials.gov ID
- NCT07066930
- Acronym / sponsor ID
- HMUD2425177
- Conditions
- Dental Implant
- Keywords
- Ridge expansion, Osseodensification, Magnetic mallet, Dental implants
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hawler Medical UniversityUniversity, hospital or other
- Collaborators
- Universidad de Granada
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 15 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.
The goal of this clinical trial is to compare two surgical techniques-Magneto-Dynamic Ridge Splitting and Versah Osseodensification-for expanding narrow alveolar ridges in adults requiring dental implant placement. The main questions it aims to answer are:
Which technique better preserves alveolar bone width after surgery?
Which method results in higher primary implant stability?
Researchers will compare ridge splitting using the Magnetic Mallet to ridge expansion using Versah drills to see if one technique leads to better clinical outcomes, such as improved bone preservation, greater implant stability, and favorable soft tissue response.
Participants will:
Undergo ridge expansion surgery using either the Magnetic Mallet or Versah drills, followed by immediate dental implant placement.
Receive CBCT scans before and 4 months after surgery to measure bone changes.
Undergo implant stability testing using the ISQ (Implant Stability Quotient) method.
Have intraoral scans to evaluate changes in soft tissue volume and thickness.
Detailed description
This clinical trial aims to evaluate and compare two innovative techniques used to widen narrow jawbone areas (alveolar ridges) in preparation for dental implants. In many patients, the bone in the jaw may be too thin to support dental implants without additional procedures. Traditionally, this problem has been addressed using more invasive surgical methods that can involve bone grafting and extended healing times.
The two techniques being studied are:
Magneto-Dynamic Ridge Splitting (Magnetic Mallet) - This method uses gentle electromagnetic impulses to gradually split and expand the bone. The technique is minimally traumatic, preserves the outer bone layer (cortical bone), and may promote better healing and stability for implants.
Osseodensification (Versah Drills) - This technique uses specially designed rotating drills (Densah burs) that do not remove bone but instead compact it outward, increasing its density. This approach is designed to strengthen the implant site and improve how well the implant integrates with the bone.
The study is a randomized controlled clinical trial conducted at Hawler Medical University. Participants will be randomly assigned to one of the two groups. Both groups will receive immediate implant placement following the ridge expansion procedure, using the same implant system (ROOTT Implants).
Key outcomes to be measured include:
Changes in bone width (buccolingual ridge dimension) using Cone Beam Computed Tomography (CBCT) before and 4 months after surgery.
Implant Stability Quotient (ISQ) values recorded at the time of implant placement and again during the second-stage surgery using a non-invasive resonance frequency analysis device (Osstell).
Soft tissue changes, such as thickness and volume around the implant site, using intraoral scanning technology.
The trial will also monitor patient comfort, healing, and potential complications in each group. By directly comparing these two methods, the researchers hope to determine which approach provides better clinical outcomes in terms of bone preservation, implant stability, and soft tissue health. The results may help establish a new standard in minimally invasive implant site preparation techniques and guide oral surgeons and implantologists in choosing the most effective ridge expansion strategy for their patients.
This study will be conducted in accordance with ethical standards, and all participants will be asked to provide informed consent prior to joining the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magneto-Dynamic Ridge Splitting | Experimental | Procedure: Magneto-Dynamic Ridge ExpansionParticipants in this arm will undergo ridge expansion using the Magnetic Mallet system. The procedure involves magneto-dynamic impulses to laterally expand the alveolar ridge prior to dental implant placement. |
| Versah Osseodensification | Active comparator | Procedure: Osseodensification with Versah DrillsParticipants in this arm will undergo ridge expansion using Versah drills (Densah burs) in osseodensification mode prior to dental implant placement. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults aged 18 to 70 years.
- Partially edentulous patients requiring ridge expansion prior to dental implant placement.
- Alveolar ridge width between 4 mm and 6 mm as measured on CBCT.
- Sufficient vertical bone height for implant placement without the need for vertical augmentation.
- Adequate oral hygiene and commitment to postoperative care and follow-up visits.
Key exclusion criteria (6 listed)
- Presence of systemic conditions contraindicating oral surgery (e.g., uncontrolled diabetes, immune-compromised status).
- History of bisphosphonate therapy or radiation therapy to the head and neck region.
- Active periodontal disease or untreated oral infections.
- Heavy smokers (more than 10 cigarettes per day).
- Pregnant or breastfeeding women.
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 |
|---|---|---|
| Magneto-Dynamic Ridge ExpansionA ridge expansion technique using the Magnetic Mallet device. Controlled magneto-dynamic impulses are applied to split the alveolar ridge and compact bone prior to immediate implant placement. | Procedure or surgery | Magneto-Dynamic Ridge Splitting |
| Osseodensification with Versah DrillsA ridge expansion method using Versah drills (Densah burs) in osseodensification mode. The drills densify bone without removing it, enhancing bone density and implant stability. Arm Assignment: Versah Osseodensification (Active Comparator arm) | Procedure or surgery | Versah Osseodensification |
Primary outcome
Change in Alveolar Ridge Width (Buccolingual Dimension)
Time frame: 4 Months
Measurement of alveolar ridge width in millimeters using Cone Beam Computed Tomography (CBCT) to assess the horizontal bone gain after ridge expansion with either the Magneto-Dynamic Ridge Splitting or Versah Osseodensification technique.
Change in Alveolar Ridge Width (Buccolingual Dimension)
Time frame: Baseline (pre-operative) and 4 months post-surgery
Measurement of alveolar ridge width in millimeters using Cone Beam Computed Tomography (CBCT) to assess the horizontal bone gain after ridge expansion with either the Magneto-Dynamic Ridge Splitting or Versah Osseodensification technique.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. We have not yet determined whether individual participant data (IPD) will be shared with other researchers. The decision will depend on the outcomes of the study, institutional policies, ethical approvals, and potential publication requirements. Any future data sharing will comply with applicable data protection regulations and will require appropriate de-identification and ethical clearance.
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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.
Jodal Ahmed, PhD study director
Oral and Maxillofacial Surgery Department, College of Dentistry, Hawler Medical University, Erbil, Kurdistan Region, Iraq.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magneto-Dynamic Ridge Expansion and Osseodensification with Versah Drills in people with Dental Implant, run by Hawler Medical University at 1 site in Iraq.
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 6 inclusion and 6 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: opening soon, as of the sponsor's last update on 15 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 Iraq. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abduljaleel Azad Samad, PhD (+9647504843344, abduljaleel.azad@hmu.edu.krd), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Alveolar Ridge Width (Buccolingual Dimension) (time frame: 4 Months). 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 15 Jul 2025.