Maxillary Sinus DiseaseprelacrimalNCT07332585
Efficacy of Piezosurgery Versus Conventional Osteotomy in Prelacrimal Approach Targeting Different Maxillary Sinus Pathologies
A study testing piezo-assisted prelacrimal apporach and conventional osteotomy prelacrimal approach in people with Maxillary Sinus Disease, run by Mansoura University at 1 site in Egypt.
Trial summary
The prelacrimal recess approach is a minimally invasive approach to maxillary sinus lesions. The current study aimed to evaluate the efficacy of piezosurgery versus conventional osteotomy while performing a prelacrimal apporach. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Maxillary Sinus Disease
- What is being tested?
- piezo-assisted prelacrimal apporach and conventional osteotomy prelacrimal approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2024to 30 Nov 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any maxillary sinus pathology (recurrent Antrochoanal polyp, inverted papilloma, fungal ball, allergic fungal sinusitis, CRSwNP, CRSeNP, orbital floor fracture, etc).
- Favorable prelacrimal recess (Type II or III Simmen classification)
- Age> 18 years.
- No gender limitation.
Who cannot join
- patients with malignant sino-nasal tumors.
- patients unfit for surgery
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Medicine, Mansoura University
Al Mansurah, Dakahlia Governorate, 35511
About this study
Official title: Efficacy of Piezosurgery Versus Conventional Osteotomy in Prelacrimal Approach Targeting Different Maxillary Sinus Pathologies: a Randomized Controlled Trial
The prelacrimal recess approach is a minimally invasive approach to maxillary sinus lesions. The current study aimed to evaluate the efficacy of piezosurgery versus conventional osteotomy while performing a prelacrimal apporach.
- Conditions
- Maxillary Sinus Disease
- Being tested
- piezo-assisted prelacrimal apporach, conventional osteotomy prelacrimal approach
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
piezo-assisted prelacrimal apporachProcedure or surgery
The removal of the bone in the prelacrimal approach was done using piezo ultrasonic device
conventional osteotomy prelacrimal approachProcedure or surgery
The removal of the bone in the prelacrimal approach was done using conventional osteotome and hammer
| Study group | Role | What they receive |
|---|---|---|
| piezosurgery group | Active comparator | Not described Receives: Procedure: piezo-assisted prelacrimal apporach |
| conventional osteotomy group | Active comparator | Not described Receives: Procedure: conventional osteotomy prelacrimal approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative bleeding
The amount of blood collected in the suction device
Measured: During the surgical procedure
Operative time
the time of surgical procedure
Measured: During the surgical procedure
Secondary outcomes (1)
Postoperative hyposthesia
hyposthesia in the cheek and upper teeth after surgery, measured by the Barrow Institution grading of hyposthesia
Measured: six months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start1 Dec 2024
- Primary completion30 Nov 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maxillary Sinus DiseaseStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07332585
- Sponsor's protocol ID
- MS.24.11.2964
- Acronym
- prelacrimal
- Status last verified
- Dec 2025
- First submitted
- 30 Dec 2025
- Last updated
- 12 Jan 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 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Piezosurgery Versus Conventional Osteotomy in Prelacrimal Approach Targeting Different Maxillary Sinus Pathologies: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07332585
- Acronym / sponsor ID
- prelacrimal / MS.24.11.2964
- Conditions
- Maxillary Sinus Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 12 Jan 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.
The prelacrimal recess approach is a minimally invasive approach to maxillary sinus lesions. The current study aimed to evaluate the efficacy of piezosurgery versus conventional osteotomy while performing a prelacrimal apporach.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| piezosurgery group | Active comparator | Procedure: piezo-assisted prelacrimal apporach |
| conventional osteotomy group | Active comparator | Procedure: conventional osteotomy prelacrimal approach |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Any maxillary sinus pathology (recurrent Antrochoanal polyp, inverted papilloma, fungal ball, allergic fungal sinusitis, CRSwNP, CRSeNP, orbital floor fracture, etc).
- Favorable prelacrimal recess (Type II or III Simmen classification)
- Age> 18 years.
- No gender limitation.
Key exclusion criteria (2 listed)
- patients with malignant sino-nasal tumors.
- patients unfit for surgery
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 |
|---|---|---|
| piezo-assisted prelacrimal apporachThe removal of the bone in the prelacrimal approach was done using piezo ultrasonic device | Procedure or surgery | piezosurgery group |
| conventional osteotomy prelacrimal approachThe removal of the bone in the prelacrimal approach was done using conventional osteotome and hammer | Procedure or surgery | conventional osteotomy group |
Primary outcome
Intraoperative bleeding
Time frame: During the surgical procedure
The amount of blood collected in the suction device
Operative time
Time frame: During the surgical procedure
the time of surgical procedure
1 secondary outcome
Postoperative hyposthesia
Time frame: six months after surgery
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 Jan 2026.
Related trials for Maxillary Sinus Disease
Recruiting
Two Bovine Xenografts in Lateral Window Sinus Augmentation With or Without Bone Marrow Blood
Alveolar Bone Loss, Sinus Floor Augmentation
Recruiting
The Application of a Biphasic Calcium Sulfate Graft Material in Sinus Floor Elevation
Alveolar Bone Loss, Edentulism Nos
Not yet recruiting
Buccal Periosteal Inversion Flap vs Buccal Advancement Flap for Acute Oro-Antral Communication Closure
Acute Oroantral Communication
Active, not recruitingPhase 2
Customized 3D Printed Oral Stents During Head and Neck Radiotherapy
Head and Neck Carcinoma, Malignant Parotid Gland Neoplasm
RecruitingPhase 1
Testing the Addition of Ipatasertib to Usual Chemotherapy and Radiation for Head and Neck Cancer
Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
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 piezo-assisted prelacrimal apporach and conventional osteotomy prelacrimal approach in people with Maxillary Sinus Disease, run by Mansoura 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 Jan 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?
Intraoperative bleeding (time frame: During the surgical procedure). 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 12 Jan 2026.