Efficacy of Piezosurgery Versus Conventional Osteotomy in Prelacrimal Approach Targeting Different Maxillary Sinus Pathologies (prelacrimal)

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.

Study Overview

• Status: Completed
• Conditions: Maxillary Sinus Disease
• Intervention / Treatment: Procedure: piezo-assisted prelacrimal apporach; Procedure: conventional osteotomy prelacrimal approach

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Dakahlia Governorate
    • Al Mansurah, Dakahlia Governorate, Egypt, 35511
      • Faculty of Medicine, Mansoura University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Any maxillary sinus pathology (recurrent Antrochoanal polyp, inverted papilloma, fungal ball, allergic fungal sinusitis, CRSwNP, CRSeNP, orbital floor fracture, etc).
2. Favorable prelacrimal recess (Type II or III Simmen classification)
3. Age> 18 years.
4. No gender limitation.

Exclusion Criteria:

1. patients with malignant sino-nasal tumors.
2. patients unfit for surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: piezosurgery group	Procedure: piezo-assisted prelacrimal apporach; The removal of the bone in the prelacrimal approach was done using piezo ultrasonic device
Active Comparator: conventional osteotomy group	Procedure: conventional osteotomy prelacrimal approach; The removal of the bone in the prelacrimal approach was done using conventional osteotome and hammer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative bleeding	The amount of blood collected in the suction device	During the surgical procedure
Operative time	the time of surgical procedure	During the surgical procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative hyposthesia	hyposthesia in the cheek and upper teeth after surgery, measured by the Barrow Institution grading of hyposthesia	six months after surgery

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2024
• Primary Completion (Actual): November 30, 2025
• Study Completion (Actual): November 30, 2025

Study Registration Dates

• First Submitted: December 30, 2025
• First Submitted That Met QC Criteria: December 30, 2025
• First Posted (Estimated): January 12, 2026

Study Record Updates

• Last Update Posted (Estimated): January 12, 2026
• Last Update Submitted That Met QC Criteria: December 30, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: MS.24.11.2964

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No