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NCT Number: NCT07044882

Hydrodynamic Piezoelectric Technique in Internal Sinus Lift

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.

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Key information

Age range

30 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry clinics, Beirut Arab University

Beirut, Lebanon

Location contact

Joseph Alkhoury, BDS

CONTACT

Joseph Alkhoury, BDS

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Exclusion criteria

-

Treatment and study plan

conventional osteotome technique

Procedure

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

Other names: Control group

Hydrodynamic Piezoelectric technique

Procedure

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

Primary outcomes

  1. Change in pain scores

    Time frame: at 7, 14, and 21 days

    Pain will be evaluated, using visual analogue scale (VAS) as follows:

    (0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe).

  2. Change in wound healing

    Time frame: at 7, 14, and 21 days

    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

  3. change in implant stability

    Time frame: baseline and 6 months

    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.

Secondary outcomes

  1. Change in Alveolar Process height gain

    Time frame: baseline and 6 months

    The baseline residual alveolar bone height will be measured in the preoperative scan from the alveolar crest to the maxillary sinus floor. Immediate postoperative alveolar bone height will be measured to outline the effectiveness of sinus membrane elevation using CBCT

Study contacts

Contact information is provided by the study sponsor or research team.

Joseph Alkhoury, BDS

CONTACT

[email protected]

+961 71 832 772

Sponsors and collaborators

Lead sponsor

Hams Hamed Abdelrahman

Other

Registry information

Official study title

Evaluation of the Hydrodynamic Piezoelectric Technique in Internal Sinus Lift With Simultaneous Implant Placement (A Randomized Controlled Clinical Trial)

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 1, 2025
Registry last updated
Jul 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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