Hydrodynamic Piezoelectric Technique in Internal Sinus Lift

NCT07044882 | Not Yet Recruiting

• 1 other identifier: 2025-H-0165-D-M-0752
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

Background: The use of hydrodynamic piezoelectric techniques for trans crestal / internal sinus lift with simultaneous implant placement has gained popularity as a safe and minimally invasive technique for managing the posterior edentulous maxilla, particularly in cases with sinus pneumatization. This method offers a controlled elevation of the Schneiderian membrane while reducing the risk of perforation compared to conventional techniques. Additionally, it minimizes postoperative discomfort and oedema, leading to better acceptance and satisfaction by the patients. In contrast to traditional osteotome tapping procedures, the hydrodynamic piezoelectric technique enhances surgical outcomes while preserving vital anatomical structures, making it a superior alternative in implant dentistry. This study aims to evaluate the use of the hydrodynamic piezoelectric technique in internal sinus lifting with simultaneous implant placement in comparison to the conventional osteotome technique.

Conditions

Maxillary Sinus Lift; Osteotome

Outcome Measures

Primary Outcomes (3)

• Change in pain scores

  Pain will be evaluated, using visual analogue scale (VAS) as follows: (0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe).

  at 7, 14, and 21 days

• Change in wound healing

  The wound healing will be assessed based on the Modified Healing Index. The Wound Healing Index (WHI) evaluates preimplant soft tissue wound healing with scores from 1 to 3. On this scale, a score of 1 indicates ordinary healing with the absence of gingival edema, erythema, suppuration, patient discomfort, and flap dehiscence. A score of 2 indicates ordinary healing with slight gingival edema, erythema, patient discomfort, and flap dehiscence, but no suppuration and a score of 3 corresponds to poor wound healing with significant gingival edema, erythema, patient discomfort, suppuration, and flap dehiscence, or any suppuration

  at 7, 14, and 21 days

• change in implant stability

  Implant Stability Quotient (ISQ) will be measured during the operative stage, while the secondary stability quotient will be measured 6-months post-operative during the prosthetic phase preparation using Ostell device.

  baseline and 6 months

Secondary Outcomes (1)

• Change in Alveolar Process height gain

  baseline and 6 months

Study Arms (2)

conventional osteotome technique

ACTIVE COMPARATOR

Procedure: conventional osteotome technique

osteotome with hydrodynamic piezoelectric

EXPERIMENTAL

Procedure: Hydrodynamic Piezoelectric technique

Interventions

conventional osteotome technique PROCEDURE

Patients indicated for internal sinus lifting with simultaneous implant placement, where sinus elevation is conducted with regular manual osteotomes.

Also known as: Control group

conventional osteotome technique

Hydrodynamic Piezoelectric technique PROCEDURE

Patients indicated for internal sinus lifting with simultaneous implant placement, where sinus elevation is conducted with Hydrodynamic Piezoelectric technique.

osteotome with hydrodynamic piezoelectric

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with edentulous free end or bounded posterior maxilla that require implant supported restoration.
• Patients indicated to internal sinus lifting, where insufficient residual alveolar bone height from the alveolar crest to the floor of the maxillary sinus is found.
• Patients with residual alveolar bone height that ranges from 5-7 mm according to the tomographic radiographic examination.
• A good standard of oral hygiene.

You may not qualify if:

• Patients with residual alveolar bone height less than 5 mm according to the tomographic radiographic examination.
• Patients with residual alveolar bone height more than 8 mm according to the tomographic radiographic examination, which is not indicated to sinus lifting.
• Patient with active sinus infection or sinus pathology.
• History of Oral or intravenous bisphosphonate therapy or any treatments with other medications that may interfere with bone metabolism within the past 12 months.
• Heavy smokers.
• Medically compromised patients that are burdened with systemic conditions that contradicts implant placement and interfere with wound healing.

Sponsors & Collaborators

• Hams Hamed Abdelrahman: lead

Study Sites (1)

Faculty of Dentistry clinics, Beirut Arab University

Beirut, Lebanon

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Joseph Alkhoury, BDS

CONTACT

+961 71 832 772; Josephalkhoury@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer of Dental Public Health and biostatistical consultanat

Study Record Dates

• First Submitted: June 22, 2025
• First Posted: July 1, 2025
• Study Start: October 1, 2025
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

LE (1)