Sinus LiftingNCT06956313
Hydraulic Pressure Lateral Sinus Lift Approach
A study testing Hydraulic Pressure Lifting Technique and Piezo-Surgical Lifting Technique in people with Sinus Lifting and Piezoelectric Technique, run by Alexandria University at 1 site in Egypt.
Trial summary
the study aims to assess the effectiveness of hydraulic pressure sinus lift via lateral wall approach, versus piezoelectric surgery in patients with deficient posterior maxilla. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Sinus Lifting, Piezoelectric Technique
- What is being tested?
- Hydraulic Pressure Lifting Technique and Piezo-Surgical Lifting Technique
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2022to 1 Mar 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The study included patient with deficient posterior maxilla with less than 6mm of bone height confirmed by a pre-operative tomographic scan. All healthy (ASA I, II) non- smoker patients were eligible for the study. The absence of uncontrolled diabetes, systemic illnesses, sinusitis, immune deficiency disorders, were also required for inclusion.
Who cannot join
- Patients with sinus infection, neoplasm or a large cyst of the sinus, or those who previously underwent a Caldwell-Luc surgery for the same surgical site were excluded
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry, Alexandria University
Alexandria, Alexandria Governorate, 21523
About this study
Official title: Hydraulic Pressure Sinus Lift Versus Piezoelectric Lift Via Lateral Approach: A Randomized Controlled Clinical Trial.
the study aims to assess the effectiveness of hydraulic pressure sinus lift via lateral wall approach, versus piezoelectric surgery in patients with deficient posterior maxilla.
Read the detailed description
This study involves a randomized clinical trial of 20 participants with less than 6 mm bone height in the posterior maxilla in need of Maxillary Sinus Floor Augmentation using the lateral window approach. Patients will be randomly assigned to two groups; the HPLT Group which include 10 patients who will undergo hydraulic pressure for osteotomy preparation for lateral sinus lifting technique, and the PSLT Group which include 10 patients managed using piezoelectric surgery. Clinical and radiographic assessment of bone augmentation, as well as intraoperative biological complications and postoperative complications were recorded.
- Conditions
- Sinus Lifting, Piezoelectric Technique
- Being tested
- Hydraulic Pressure Lifting Technique, Piezo-Surgical Lifting Technique
- Keywords
- advanced intelligence drill, Sinus lift, hydraulic pressure sinus lift, external sinus lift,, piezoelectric surgery, lateral approach
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydraulic Pressure Lifting TechniqueDevice
Hydraulic Pressure Lifting Technique
Piezo-Surgical Lifting TechniqueDevice
Piezo-Surgical Lifting Technique
| Study group | Role | What they receive |
|---|---|---|
| HPLT Group | Experimental | patients with posterior deficient maxilla managed with osteotomy for lateral sinus floor augmentation using the Hydraulic Pressure Lifting Technique with A.I drill and hydraulic-powered Aqua-Lifter (OLA system) were assigned to HPLT Group Receives: Device: Hydraulic Pressure Lifting Technique |
| PSLT Group | Experimental | posterior deficient maxilla managed with osteotomy for lateral sinus floor augmentation using Piezo-Surgical Lifting Technique were assigned to PSLT Group Receives: Device: Piezo-Surgical Lifting Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
radiographic appraisal of gain in alveolar bone height
Postoperative radiographic appraisal was conducted by an immediate postoperative CBCT, followed by other one after 6 postoperative month's. Measurements of the bone height was conducted from the alveolar crest to the floor of the maxillary sinus on a cross-section view of the CBCT (Carestream Health, Rochester, NY). Radiographic assessment of the amount of bone height gain in 6 months period was performed by comparing the bone height measurements between the 6 postoperative months' CBCT with the preoperative scan.
Measured: 6 months
Secondary outcomes (1)
incidence of membrane perforation
incidence of membrane perforation during the operation was assessed in both groups
Measured: Until the end of the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2025
- Study start1 Feb 2022
- Primary completion1 Oct 2024
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sinus LiftingStudies 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
- Investigator
- 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
- NCT06956313
- Sponsor's protocol ID
- HPLT-4-25
- Status last verified
- Apr 2025
- First submitted
- 1 May 2025
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all data will be de-identified to protect the participant data. patients signed an informed consent for the use of their medical records and data for study
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hydraulic Pressure Sinus Lift Versus Piezoelectric Lift Via Lateral Approach: A Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT06956313
- Acronym / sponsor ID
- HPLT-4-25
- Conditions
- Sinus Lifting, Piezoelectric Technique
- Keywords
- advanced intelligence drill, Sinus lift, hydraulic pressure sinus lift, external sinus lift,, piezoelectric surgery, lateral approach
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 4 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.
the study aims to assess the effectiveness of hydraulic pressure sinus lift via lateral wall approach, versus piezoelectric surgery in patients with deficient posterior maxilla.
Detailed description
This study involves a randomized clinical trial of 20 participants with less than 6 mm bone height in the posterior maxilla in need of Maxillary Sinus Floor Augmentation using the lateral window approach. Patients will be randomly assigned to two groups; the HPLT Group which include 10 patients who will undergo hydraulic pressure for osteotomy preparation for lateral sinus lifting technique, and the PSLT Group which include 10 patients managed using piezoelectric surgery. Clinical and radiographic assessment of bone augmentation, as well as intraoperative biological complications and postoperative complications were recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HPLT Group | Experimental | Device: Hydraulic Pressure Lifting Techniquepatients with posterior deficient maxilla managed with osteotomy for lateral sinus floor augmentation using the Hydraulic Pressure Lifting Technique with A.I drill and hydraulic-powered Aqua-Lifter (OLA system) were assigned to HPLT Group |
| PSLT Group | Experimental | Device: Piezo-Surgical Lifting Techniqueposterior deficient maxilla managed with osteotomy for lateral sinus floor augmentation using Piezo-Surgical Lifting Technique were assigned to PSLT Group |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The study included patient with deficient posterior maxilla with less than 6mm of bone height confirmed by a pre-operative tomographic scan. All healthy (ASA I, II) non- smoker patients were eligible for the study. The absence of uncontrolled diabetes, systemic illnesses, sinusitis, immune deficiency disorders, were also required for inclusion.
Key exclusion criteria (1 listed)
- Patients with sinus infection, neoplasm or a large cyst of the sinus, or those who previously underwent a Caldwell-Luc surgery for the same surgical site were excluded
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 |
|---|---|---|
| Hydraulic Pressure Lifting TechniqueHydraulic Pressure Lifting Technique | Device | HPLT Group |
| Piezo-Surgical Lifting TechniquePiezo-Surgical Lifting Technique | Device | PSLT Group |
Primary outcome
radiographic appraisal of gain in alveolar bone height
Time frame: 6 months
Postoperative radiographic appraisal was conducted by an immediate postoperative CBCT, followed by other one after 6 postoperative month's. Measurements of the bone height was conducted from the alveolar crest to the floor of the maxillary sinus on a cross-section view of the CBCT (Carestream Health, Rochester, NY). Radiographic assessment of the amount of bone height gain in 6 months period was performed by comparing the bone height measurements between the 6 postoperative months' CBCT with the preoperative scan.
1 secondary outcome
incidence of membrane perforation
Time frame: Until the end of the operation
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 4 May 2025.
- Individual participant dataSharing planned: Yes. all data will be de-identified to protect the participant data. patients signed an informed consent for the use of their medical records and data for study
Related trials for Sinus Lifting
Recruiting
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Effect of Changing Grafting Sequences During Sinus Lifting & Simultaneous Implant Placement in the Gained Bone Using Customized Surgical Guide
Vertical Bone Defects, Missing Tooth/Teeth
Active, not recruiting
Endoscopic-Assisted Versus Conventional Crestal Sinus Lift
Bone Defects
Recruiting
Two-Stage Transcrestal Sinus Lift With Osseodensification: Allograft vs Autogenous-Xenograft
Severely Atrophic Posterior Maxilla
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 Hydraulic Pressure Lifting Technique and Piezo-Surgical Lifting Technique in people with Sinus Lifting and Piezoelectric Technique, 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 1 inclusion and 1 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 4 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?
radiographic appraisal of gain in alveolar bone height (time frame: 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 4 May 2025.