Hydraulic Pressure Lateral Sinus Lift Approach

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.

Study Overview

• Status: Completed
• Conditions: Sinus Lifting; Piezoelectric Technique
• Intervention / Treatment: Device: Hydraulic Pressure Lifting Technique; Device: Piezo-Surgical Lifting Technique

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt, 21523
    • Faculty of Dentistry, Alexandria University

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HPLT Group; 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	Device: Hydraulic Pressure Lifting Technique; Hydraulic Pressure Lifting Technique
Experimental: PSLT Group; posterior deficient maxilla managed with osteotomy for lateral sinus floor augmentation using Piezo-Surgical Lifting Technique were assigned to PSLT Group	Device: Piezo-Surgical Lifting Technique; Piezo-Surgical Lifting Technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of membrane perforation	incidence of membrane perforation during the operation was assessed in both groups	Until the end of the operation

Collaborators and Investigators

• Sponsor: Alexandria University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Actual): October 1, 2024
• Study Completion (Actual): March 1, 2025

Study Registration Dates

• First Submitted: May 1, 2025
• First Submitted That Met QC Criteria: May 1, 2025
• First Posted (Actual): May 4, 2025

Study Record Updates

• Last Update Posted (Actual): May 4, 2025
• Last Update Submitted That Met QC Criteria: May 1, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: piezoelectric surgery; lateral approach; Sinus lift; advanced intelligence drill; hydraulic pressure sinus lift; external sinus lift,
• Other Study ID Numbers: HPLT-4-25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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
• IPD Sharing Supporting Information Type: SAP

Drug and device information, study documents

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