Alveolar Bone LossNCT07467369
Magnetic Mallet and Piezotome in Atrophic Anterior Maxillary Ridge Expansion With Simultaneous Bone Graft and Implant Placement (
A study testing ridge expansion by magnetic mallet and ridge expansion by piezotome in people with Alveolar Bone Loss, run by Alexandria University at 1 site in Egypt.
Trial summary
Background: teeth loss in the anterior maxilla initiate residual ridge resorption, especially in the anterior region. The consequence of this resorption is a gradual medial or palatal shift of the crest of maxilla. This results in change in facial morphology as result of diminished maxillary lip support. Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Alveolar Bone Loss
- What is being tested?
- ridge expansion by magnetic mallet and ridge expansion by piezotome
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 19 Jan 2025to 21 Jul 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 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- alveolar ridge width from 3-5 mm
- Patient with missing more than two anterior maxillary teeth
- Patient with good oral hygiene and acceptable inter-arch space[8-12mm] for the restoration
- D3 bone density
Who cannot join
- Heavy smoker, alcohol abuse, parafunctional habits.
- Patient with uncontrolled hypertension, uncontrolled diabetes, on radiation therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Magnetic Mallet and Piezotome in Atrophic Anterior Maxillary Ridge Expansion With Simultaneous Bone Graft and Implant Placement (Randomized Clinical Trial)
Background: teeth loss in the anterior maxilla initiate residual ridge resorption, especially in the anterior region. The consequence of this resorption is a gradual medial or palatal shift of the crest of maxilla. This results in change in facial morphology as result of diminished maxillary lip support. This may also lead to compromised occlusal relationship of prosthetic teeth as they are positioned labially to the crest of alveolar ridge.
Aim: to compare the use of magnetic mallet and piezotome in atrophic anterior maxillary ridge expansion with simultaneous bone graft and implant placement.Materials and Methods: 20 patients with anterior atrophic maxilla will be included in the study. Patients will be divided into two groups, group A the bone expansion will be done by the magnetic mallet. Group B the bone expansion will be done by the piezotome , both groups will have bone graft and implant.
clinical evaluation will include intra operative and post operative evaluation, primary and secondary stability, operative time and time . Radiographic evaluation will include bone density and marginal bone loss around the tnalpmi
- Conditions
- Alveolar Bone Loss
- Being tested
- ridge expansion by magnetic mallet, ridge expansion by piezotome
- 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.
ridge expansion by magnetic malletProcedure or surgery
Surgery will be performed under local anesthesia using articaine with 1:100,000 adrenaline, a full-thickness buccal and palatal flaps will be raised. After the flaps were reflected, the crestal incision will be performed into the bone to perform an intra-osseous groove with an n. 64 beaver blade attached to magnetic mallet, this groove will be continued apically down to 7-11mm. The implant site will be created by expanding the bone tissue both laterally against the preexisting walls and apically by using osteotome attached to magnetic mallet, in this way the buccal plate will be slowly dislocated in a facial direction.
ridge expansion by piezotomeProcedure or surgery
Surgery will be performed under local anesthesia using articaine with 1:100,000 adrenaline, after exposing the ridge, a sagittal osteotomy of 1mm depth will be outlined in the cortical bone by using sharp piezoelectric insert no. OT2. After that the sagittal osteotomic cut will be deepened with a 0.25 mm diameter piezoelectric micro-saw no. OT12s toward apical direction, at depth equivalent to the planned implant length. When the bone cuts will be completed, the ridges will be separated in buccal/lingual direction using densah burs . Then implants will be placed within the confines of the newly created space .
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Not described Receives: Procedure: ridge expansion by piezotome |
| Control Group | Active comparator | Not described Receives: Procedure: ridge expansion by magnetic mallet |
What is being measured
The primary outcome is the main question the study is designed to answer.
secondary implant stability
(2ry stability ) will be recorded after 6 months by using osstell device. The result is presented in form of ISQ value from 1to 100, the higher the ISQ the higher the stability of implant.
Measured: up to 6 months
Secondary outcomes (4)
change in pain scores
Pain will be assessed for 7 days postoperatively using 10-point visual analouge scale (VAS)(0-1=None, 2-4=mild, 5-7=moderate, 8-10=severe )
Measured: up to 7 days
change in labial bone thickness
it will be measured on CBCT
Measured: baseline and 6 months
Marginal bone loss
it will be measured on CBCT
Measured: up to 6 months
change in bone density
it will be measured on CBCT
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start19 Jan 2025
- Primary completion21 Jul 2025
- Study completion21 Jul 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 Alexandria 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07467369
- Sponsor's protocol ID
- 0915-05/2024
- Status last verified
- Mar 2026
- First submitted
- 9 Mar 2026
- Last updated
- 12 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Magnetic Mallet and Piezotome in Atrophic Anterior Maxillary Ridge Expansion With Simultaneous Bone Graft and Implant Placement (Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT07467369
- Acronym / sponsor ID
- 0915-05/2024
- Conditions
- Alveolar Bone Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 19 Jan 2025 (actual)
- Primary completion
- 21 Jul 2025 (actual)
- Study completion
- 21 Jul 2025 (actual)
- First posted
- 12 Mar 2026 (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.
Background: teeth loss in the anterior maxilla initiate residual ridge resorption, especially in the anterior region. The consequence of this resorption is a gradual medial or palatal shift of the crest of maxilla. This results in change in facial morphology as result of diminished maxillary lip support. This may also lead to compromised occlusal relationship of prosthetic teeth as they are positioned labially to the crest of alveolar ridge.
Aim: to compare the use of magnetic mallet and piezotome in atrophic anterior maxillary ridge expansion with simultaneous bone graft and implant placement.Materials and Methods: 20 patients with anterior atrophic maxilla will be included in the study. Patients will be divided into two groups, group A the bone expansion will be done by the magnetic mallet. Group B the bone expansion will be done by the piezotome , both groups will have bone graft and implant.
clinical evaluation will include intra operative and post operative evaluation, primary and secondary stability, operative time and time . Radiographic evaluation will include bone density and marginal bone loss around the tnalpmi
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Procedure: ridge expansion by piezotome |
| Control Group | Active comparator | Procedure: ridge expansion by magnetic mallet |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- alveolar ridge width from 3-5 mm
- Patient with missing more than two anterior maxillary teeth
- Patient with good oral hygiene and acceptable inter-arch space[8-12mm] for the restoration
- D3 bone density
Key exclusion criteria (2 listed)
- Heavy smoker, alcohol abuse, parafunctional habits.
- Patient with uncontrolled hypertension, uncontrolled diabetes, on radiation therapy
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 |
|---|---|---|
| ridge expansion by magnetic malletSurgery will be performed under local anesthesia using articaine with 1:100,000 adrenaline, a full-thickness buccal and palatal flaps will be raised. After the flaps were reflected, the crestal incision will be performed into the bone to perform an intra-osseous groove with an n. 64 beaver blade attached to magnetic mallet, this groove will be continued apically down to 7-11mm. The implant site will be created by expanding the bone tissue both laterally against the preexisting walls and apically by using osteotome attached to magnetic mallet, in this way the buccal plate will be slowly dislocated in a facial direction. | Procedure or surgery | Control Group |
| ridge expansion by piezotomeSurgery will be performed under local anesthesia using articaine with 1:100,000 adrenaline, after exposing the ridge, a sagittal osteotomy of 1mm depth will be outlined in the cortical bone by using sharp piezoelectric insert no. OT2. After that the sagittal osteotomic cut will be deepened with a 0.25 mm diameter piezoelectric micro-saw no. OT12s toward apical direction, at depth equivalent to the planned implant length. When the bone cuts will be completed, the ridges will be separated in buccal/lingual direction using densah burs . Then implants will be placed within the confines of the newly created space . | Procedure or surgery | Study group |
Primary outcome
secondary implant stability
Time frame: up to 6 months
(2ry stability ) will be recorded after 6 months by using osstell device. The result is presented in form of ISQ value from 1to 100, the higher the ISQ the higher the stability of implant.
4 secondary outcomes
change in pain scores
Time frame: up to 7 days
change in labial bone thickness
Time frame: baseline and 6 months
Marginal bone loss
Time frame: up to 6 months
change in bone density
Time frame: up to 6 months
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 12 Mar 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ridge expansion by magnetic mallet and ridge expansion by piezotome in people with Alveolar Bone Loss, run by Alexandria 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 4 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 12 Mar 2026. 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?
secondary implant stability (time frame: up to 6 months). 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 12 Mar 2026.