Maxillary Sinus LiftNCT07044882
Hydrodynamic Piezoelectric Technique in Internal Sinus Lift
A study testing conventional osteotome technique and Hydrodynamic Piezoelectric technique in people with Maxillary Sinus Lift and Osteotome, run by Hams Hamed Abdelrahman at 1 site in Lebanon.
Trial summary
Background: The use of hydrodynamic piezoelectric techniques for trans crestal / internal sinus lift with simultaneous implant placement has gained popularity as a safe and minimally invasive technique for managing the posterior edentulous maxilla, particularly in cases with sinus pneumatization. Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Maxillary Sinus Lift, Osteotome
- What is being tested?
- conventional osteotome technique and Hydrodynamic Piezoelectric technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteLebanon
- Study dates
- 1 Oct 2025to 30 Apr 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 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with edentulous free end or bounded posterior maxilla that require implant supported restoration.
- Patients indicated to internal sinus lifting, where insufficient residual alveolar bone height from the alveolar crest to the floor of the maxillary sinus is found.
- Patients with residual alveolar bone height that ranges from 5-7 mm according to the tomographic radiographic examination.
- A good standard of oral hygiene.
Who cannot join
- Patients with residual alveolar bone height less than 5 mm according to the tomographic radiographic examination.
- Patients with residual alveolar bone height more than 8 mm according to the tomographic radiographic examination, which is not indicated to sinus lifting.
- Patient with active sinus infection or sinus pathology.
- History of Oral or intravenous bisphosphonate therapy or any treatments with other medications that may interfere with bone metabolism within the past 12 months.
- Heavy smokers.
- Medically compromised patients that are burdened with systemic conditions that contradicts implant placement and interfere with wound healing.
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lebanon1 site
Faculty of Dentistry clinics, Beirut Arab University
Beirut
Joseph Alkhoury, BDS
Joseph Alkhoury, BDS
About this study
Official title: Evaluation of the Hydrodynamic Piezoelectric Technique in Internal Sinus Lift With Simultaneous Implant Placement (A Randomized Controlled Clinical Trial)
Background: The use of hydrodynamic piezoelectric techniques for trans crestal / internal sinus lift with simultaneous implant placement has gained popularity as a safe and minimally invasive technique for managing the posterior edentulous maxilla, particularly in cases with sinus pneumatization. This method offers a controlled elevation of the Schneiderian membrane while reducing the risk of perforation compared to conventional techniques. Additionally, it minimizes postoperative discomfort and oedema, leading to better acceptance and satisfaction by the patients. In contrast to traditional osteotome tapping procedures, the hydrodynamic piezoelectric technique enhances surgical outcomes while preserving vital anatomical structures, making it a superior alternative in implant dentistry. This study aims to evaluate the use of the hydrodynamic piezoelectric technique in internal sinus lifting with simultaneous implant placement in comparison to the conventional osteotome technique.
- Conditions
- Maxillary Sinus Lift, Osteotome
- Being tested
- conventional osteotome technique, Hydrodynamic Piezoelectric technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional osteotome techniqueProcedure or surgery
Also called Control group
Patients indicated for internal sinus lifting with simultaneous implant placement, where sinus elevation is conducted with regular manual osteotomes.
Hydrodynamic Piezoelectric techniqueProcedure or surgery
Patients indicated for internal sinus lifting with simultaneous implant placement, where sinus elevation is conducted with Hydrodynamic Piezoelectric technique.
| Study group | Role | What they receive |
|---|---|---|
| conventional osteotome technique | Active comparator | Not described Receives: Procedure: conventional osteotome technique |
| osteotome with hydrodynamic piezoelectric | Experimental | Not described Receives: Procedure: Hydrodynamic Piezoelectric technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain scores
Pain will be evaluated, using visual analogue scale (VAS) as follows:
(0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe).
Measured: at 7, 14, and 21 days
Change in wound healing
The wound healing will be assessed based on the Modified Healing Index. The Wound Healing Index (WHI) evaluates preimplant soft tissue wound healing with scores from 1 to 3. On this scale, a score of 1 indicates ordinary healing with the absence of gingival edema, erythema, suppuration, patient discomfort, and flap dehiscence. A score of 2 indicates ordinary healing with slight gingival edema, erythema, patient discomfort, and flap dehiscence, but no suppuration and a score of 3 corresponds to poor wound healing with significant gingival edema, erythema, patient discomfort, suppuration, and flap dehiscence, or any suppuration
Measured: at 7, 14, and 21 days
change in implant stability
Implant Stability Quotient (ISQ) will be measured during the operative stage, while the secondary stability quotient will be measured 6-months post-operative during the prosthetic phase preparation using Ostell device.
Measured: baseline and 6 months
Secondary outcomes (1)
Change in Alveolar Process height gain
The baseline residual alveolar bone height will be measured in the preoperative scan from the alveolar crest to the maxillary sinus floor. Immediate postoperative alveolar bone height will be measured to outline the effectiveness of sinus membrane elevation using CBCT
Measured: baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start1 Oct 2025 (estimated)
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maxillary Sinus LiftStudies 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
- None (open label)
- Enrolment
- 22 participants (estimated)
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
- NCT07044882
- Sponsor's protocol ID
- 2025-H-0165-D-M-0752
- Status last verified
- Jun 2025
- First submitted
- 22 Jun 2025
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Hydrodynamic Piezoelectric Technique in Internal Sinus Lift With Simultaneous Implant Placement (A Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT07044882
- Acronym / sponsor ID
- 2025-H-0165-D-M-0752
- Conditions
- Maxillary Sinus Lift, Osteotome
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 1 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.
Background: The use of hydrodynamic piezoelectric techniques for trans crestal / internal sinus lift with simultaneous implant placement has gained popularity as a safe and minimally invasive technique for managing the posterior edentulous maxilla, particularly in cases with sinus pneumatization. This method offers a controlled elevation of the Schneiderian membrane while reducing the risk of perforation compared to conventional techniques. Additionally, it minimizes postoperative discomfort and oedema, leading to better acceptance and satisfaction by the patients. In contrast to traditional osteotome tapping procedures, the hydrodynamic piezoelectric technique enhances surgical outcomes while preserving vital anatomical structures, making it a superior alternative in implant dentistry. This study aims to evaluate the use of the hydrodynamic piezoelectric technique in internal sinus lifting with simultaneous implant placement in comparison to the conventional osteotome technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional osteotome technique | Active comparator | Procedure: conventional osteotome technique |
| osteotome with hydrodynamic piezoelectric | Experimental | Procedure: Hydrodynamic Piezoelectric technique |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients with edentulous free end or bounded posterior maxilla that require implant supported restoration.
- Patients indicated to internal sinus lifting, where insufficient residual alveolar bone height from the alveolar crest to the floor of the maxillary sinus is found.
- Patients with residual alveolar bone height that ranges from 5-7 mm according to the tomographic radiographic examination.
- A good standard of oral hygiene.
Key exclusion criteria (7 listed)
- Patients with residual alveolar bone height less than 5 mm according to the tomographic radiographic examination.
- Patients with residual alveolar bone height more than 8 mm according to the tomographic radiographic examination, which is not indicated to sinus lifting.
- Patient with active sinus infection or sinus pathology.
- History of Oral or intravenous bisphosphonate therapy or any treatments with other medications that may interfere with bone metabolism within the past 12 months.
- Heavy smokers.
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 |
|---|---|---|
| conventional osteotome techniqueAlso: Control groupPatients indicated for internal sinus lifting with simultaneous implant placement, where sinus elevation is conducted with regular manual osteotomes. | Procedure or surgery | conventional osteotome technique |
| Hydrodynamic Piezoelectric techniquePatients indicated for internal sinus lifting with simultaneous implant placement, where sinus elevation is conducted with Hydrodynamic Piezoelectric technique. | Procedure or surgery | osteotome with hydrodynamic piezoelectric |
Primary outcome
Change in pain scores
Time frame: at 7, 14, and 21 days
Pain will be evaluated, using visual analogue scale (VAS) as follows: (0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe).
Change in wound healing
Time frame: at 7, 14, and 21 days
The wound healing will be assessed based on the Modified Healing Index. The Wound Healing Index (WHI) evaluates preimplant soft tissue wound healing with scores from 1 to 3. On this scale, a score of 1 indicates ordinary healing with the absence of gingival edema, erythema, suppuration, patient discomfort, and flap dehiscence. A score of 2 indicates ordinary healing with slight gingival edema, erythema, patient discomfort, and flap dehiscence, but no suppuration and a score of 3 corresponds to poor wound healing with significant gingival edema, erythema, patient discomfort, suppuration, and flap dehiscence, or any suppuration
change in implant stability
Time frame: baseline and 6 months
Implant Stability Quotient (ISQ) will be measured during the operative stage, while the secondary stability quotient will be measured 6-months post-operative during the prosthetic phase preparation using Ostell device.
1 secondary outcome
Change in Alveolar Process height gain
Time frame: baseline and 6 months
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 1 Jul 2025.
- Individual participant dataSharing planned: No
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Radiographic Changes in the Maxillary Sinus Following Closed Sinus Augmentation With Leukocyte Platelet Rich Fibrin
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional osteotome technique and Hydrodynamic Piezoelectric technique in people with Maxillary Sinus Lift and Osteotome, run by Hams Hamed Abdelrahman at 1 site in Lebanon.
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 7 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 1 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 Lebanon. 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 Joseph Alkhoury, BDS (+961 71 832 772, Josephalkhoury@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain scores (time frame: at 7, 14, and 21 days). 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 1 Jul 2025.