Dental ImplantNCT06957860
Septal Bone Expansion Using Osseodensification Versus Piezoelectric Implant Site Preparation
A study testing Piezotome and Densah burs in people with Dental Implant and Osseodensification, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial summary
: Implant placement in the inter radicular septum is usually considered the best option for an immediate molar implant, not only in terms of correct 3D positioning, but also regarding implant survival, Osseodensification was shown to enhance implant primary stability, due to the compaction auto-grafting and the… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Dental Implant, Osseodensification
- What is being tested?
- Piezotome and Densah burs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 23 Nov 2023to 24 Aug 2024
- 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult patients with hopeless mandibular molar teeth in the posterior region in need of implant placement .
- A fully intact facial bone wall at the extraction site.
- Systemically healthy, received no head and neck radiation for cancer treatment.
- Absence of periapical pathologies or suppuration at the time of installing the implants.
- Septal bone after atraumatic extraction not less than 3 mm.
Who cannot join
- Systemic conditions that would prevent successful healing or implant osseointegration; examples are uncontrolled Diabetes Mellitus, metabolic bone disorders, autoimmune diseases, or Bisphosphonate therapy.
- Heavy smoker patients.
- Presence of preapical bone loss related to extracted tooth.
- Patient is not indicated for immediate implant placement
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University
Alexandria
About this study
Official title: Septal Bone Expansion Using Osseodensification Versus Piezoelectric Implant Site Preparation for Immediate Implant Placement in Mandibular Molars [Randomized Clinical Trial]
: Implant placement in the inter radicular septum is usually considered the best option for an immediate molar implant, not only in terms of correct 3D positioning, but also regarding implant survival, Osseodensification was shown to enhance implant primary stability, due to the compaction auto-grafting and the associated spring-back effect. Piezoelectric implant site preparation (PISP) has been proposed as an alternative technique to improve surgical control, safety, and bone healing response Aim of the work: To evaluate and compare stability changes using insertion torque values (ITV) and Implant Stability Quotient values (ISQ) for immediately placed implants in molar septum using Osseodensification technique and Piezoelectric implant site preparation (PISP) technique.
- Conditions
- Dental Implant, Osseodensification
- Being tested
- Piezotome, Densah burs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PiezotomeOther
Four Intra-lift diamond tips were used for drilling the osteotomy, increasing diameters till a final diameter of 2.8 mm is reached for placement of 3.5 mm diameter and 10-12 mm length implant.
Densah bursOther
implant drilling procedures will be done using the surgical drills of the supplier kit of densah burs. Surgical drills of increasing diameters will be used till a final drill diameter of 3 mm for placement of a 3.5 mm diameter.
| Study group | Role | What they receive |
|---|---|---|
| piezoelectric group | Experimental | Not described Receives: Other: Piezotome |
| osseodensification | Experimental | Not described Receives: Other: Densah burs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in implant stability
The implant stability quotient (ISQ) will be measured using the Osstell device- resonance frequency analysis test at 3 months post-surgery to all the installed fixtures.
Measured: Baseline and 3 months
Secondary outcomes (1)
Change in bone density
Using CBCT
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2025
- Study start23 Nov 2023
- Primary completion24 Aug 2024
- Study completion24 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hams Hamed Abdelrahman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hams Hamed Abdelrahman, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06957860
- Sponsor's protocol ID
- 0716-06/2023
- Status last verified
- Apr 2025
- First submitted
- 27 Apr 2025
- Last updated
- 5 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hassan HEH, Khlalil AF, Metawie DMN. Implant stability following septal expansion in immediate mandibular molars: a pilot randomized clinical trial comparing piezoelectric surgery and osseodensification. BMC Oral Health. 2026 Jul 17;26(1):1357. doi: 10.1186/s12903-026-09257-8.
PubMed 42464273
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Septal Bone Expansion Using Osseodensification Versus Piezoelectric Implant Site Preparation for Immediate Implant Placement in Mandibular Molars [Randomized Clinical Trial]
- ClinicalTrials.gov ID
- NCT06957860
- Acronym / sponsor ID
- 0716-06/2023
- Conditions
- Dental Implant, Osseodensification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 23 Nov 2023 (actual)
- Primary completion
- 24 Aug 2024 (actual)
- Study completion
- 24 Aug 2024 (actual)
- First posted
- 5 May 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.
: Implant placement in the inter radicular septum is usually considered the best option for an immediate molar implant, not only in terms of correct 3D positioning, but also regarding implant survival, Osseodensification was shown to enhance implant primary stability, due to the compaction auto-grafting and the associated spring-back effect. Piezoelectric implant site preparation (PISP) has been proposed as an alternative technique to improve surgical control, safety, and bone healing response Aim of the work: To evaluate and compare stability changes using insertion torque values (ITV) and Implant Stability Quotient values (ISQ) for immediately placed implants in molar septum using Osseodensification technique and Piezoelectric implant site preparation (PISP) technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| piezoelectric group | Experimental | Other: Piezotome |
| osseodensification | Experimental | Other: Densah burs |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Adult patients with hopeless mandibular molar teeth in the posterior region in need of implant placement .
- A fully intact facial bone wall at the extraction site.
- Systemically healthy, received no head and neck radiation for cancer treatment.
- Absence of periapical pathologies or suppuration at the time of installing the implants.
- Septal bone after atraumatic extraction not less than 3 mm.
Key exclusion criteria (4 listed)
- Systemic conditions that would prevent successful healing or implant osseointegration; examples are uncontrolled Diabetes Mellitus, metabolic bone disorders, autoimmune diseases, or Bisphosphonate therapy.
- Heavy smoker patients.
- Presence of preapical bone loss related to extracted tooth.
- Patient is not indicated for immediate implant placement
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 |
|---|---|---|
| PiezotomeFour Intra-lift diamond tips were used for drilling the osteotomy, increasing diameters till a final diameter of 2.8 mm is reached for placement of 3.5 mm diameter and 10-12 mm length implant. | Other | piezoelectric group |
| Densah bursimplant drilling procedures will be done using the surgical drills of the supplier kit of densah burs. Surgical drills of increasing diameters will be used till a final drill diameter of 3 mm for placement of a 3.5 mm diameter. | Other | osseodensification |
Primary outcome
Change in implant stability
Time frame: Baseline and 3 months
The implant stability quotient (ISQ) will be measured using the Osstell device- resonance frequency analysis test at 3 months post-surgery to all the installed fixtures.
1 secondary outcome
Change in bone density
Time frame: Baseline and 3 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 5 May 2025.
- Derived from this study: PubMed 42464273Hassan HEH, Khlalil AF, Metawie DMN. Implant stability following septal expansion in immediate mandibular molars: a pilot randomized clinical trial comparing piezoelectric surgery and osseodensification. BMC Oral Health. 2026 Jul 17;26(1):1357. doi: 10.1186/s12903-026-09257-8.
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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 Piezotome and Densah burs in people with Dental Implant and Osseodensification, run by Hams Hamed Abdelrahman 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 4 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 5 May 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?
Change in implant stability (time frame: Baseline and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06957860, which also lists 1 linked publication.
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 5 May 2025.