Hydraulic Pressure Lateral Sinus Lift Approach

NCT06956313 | Completed

• 1 other identifier: HPLT-4-25
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sinus Lifting; Piezoelectric Technique

Keywords

advanced intelligence drill; Sinus lift; hydraulic pressure sinus lift; external sinus lift,; piezoelectric surgery; lateral approach

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• incidence of membrane perforation

  Until the end of the operation

Study Arms (2)

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

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

Device: Piezo-Surgical Lifting Technique

Interventions

Hydraulic Pressure Lifting Technique DEVICE

Hydraulic Pressure Lifting Technique

HPLT Group

Piezo-Surgical Lifting Technique DEVICE

Piezo-Surgical Lifting Technique

PSLT Group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, Alexandria Governorate, 21523, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: patients were allocated in a 1:1 ratio using an on-site computer software system with concealed allocation through sequentially numbered, opaque, sealed envelopes (SNOSE). This was a double-blind study, so neither the statistical analyst nor the patients were aware of the surgical procedure
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2025
• First Posted: May 4, 2025
• Study Start: February 1, 2022
• Primary Completion: October 1, 2024
• Study Completion: March 1, 2025
• Last Updated: May 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP

Locations

EG (1)