Hydraulic Pressure Lateral Sinus Lift Approach

NCT ID: NCT06956313

Last Updated: 2025-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-01

Study Completion Date

2025-03-01

Brief Summary

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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

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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

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Sinus Lifting Piezoelectric Technique

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators
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

Study Groups

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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

Group Type EXPERIMENTAL

Hydraulic Pressure Lifting Technique

Intervention Type DEVICE

Hydraulic Pressure Lifting Technique

PSLT Group

posterior deficient maxilla managed with osteotomy for lateral sinus floor augmentation using Piezo-Surgical Lifting Technique were assigned to PSLT Group

Group Type EXPERIMENTAL

Piezo-Surgical Lifting Technique

Intervention Type DEVICE

Piezo-Surgical Lifting Technique

Interventions

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Hydraulic Pressure Lifting Technique

Hydraulic Pressure Lifting Technique

Intervention Type DEVICE

Piezo-Surgical Lifting Technique

Piezo-Surgical Lifting Technique

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alexandria University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Faculty of Dentistry, Alexandria University

Alexandria, Alexandria Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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HPLT-4-25

Identifier Type: -

Identifier Source: org_study_id

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