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Osseodensifiction Versus Piezoelectric Internal Sinus Elevation Technique in Delayed Implant Placement

A

Ain Shams University

Status

Completed

Conditions

Maxillary Sinus Floor Augmentation

Treatments

Procedure: osseodensifiction internal sinus lift / sticky bone graft material
Procedure: piezoelectric internal sinus lift / sticky bone graft material

Study type

Interventional

Funder types

Other

Identifiers

NCT06055127
FDASU_Rec IM 122215

Details and patient eligibility

About

The present study is a parallel single-blinded randomized controlled clinical trial.

The study will be conducted after being reviewed and approved by the Faculty of Dentistry, AinShams University Research Ethics Committee (FDASU-REC).

The study population will be randomly allocated into two groups of the same size:

Group 1: Osseodensifiction sinus lift will be performed using sticky bone as a graft material.

Group 2: Piezoelectric Internal Sinus Elevation (PISE) will be performed using sticky bone as a graft material.

The aim of the present study is to evaluate the effectiveness and clinical results of osseodensification in comparison to Piezoelectric Internal Sinus Elevation (PISE) Technique in Delayed Implant Placement.

Enrollment

16 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  1. Patient partially edentulous with maxillary posterior edentulous ridge after extraction of more than 4 months.
  2. Both sexes will be selected males and females.
  3. Adult patients aged between 18 and 40 years of age.
  4. Good general health (American Society of Anesthesiology Physical Status Ⅰ-Ⅱ).
  5. Initial residual alveolar ridge height ranging between 4 to 6 mm according to preoperative CBCT.
  6. No previous surgery or radiation treatment on the maxillary sinus.

Exclusion criteria

    1. Smokers. 2. Pregnant or lactating females. 3. Psychiatric disorders. 4. Uncontrolled systemic disease. 5. Hematologic diseases and coagulation disorders. 6. Chemotherapy or radiotherapy of the head and neck area, and immunocompromised status.

    2. Medical conditions affecting bone metabolism and ongoing treatment with bisphosphonates drugs or systemic steroids.

    3. Presence of acute or chronic sinus pathoses or sinus membrane perforation.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

16 participants in 2 patient groups

osseodensifiction internal sinus lift / sticky bone graft material
Experimental group
Description:
Osseodensifiction compacts bone and simultaneously autografts it into the osteotomy walls and apex instead of removing it. The use of a Densah® drill bit at high speed counterclockwise, without a cutting edge and with a steady irrigation causes the formation of a layer of strong dense bone along the walls of the base of the osteotomy preparation.
Treatment:
Procedure: osseodensifiction internal sinus lift / sticky bone graft material
piezoelectric internal sinus lift / sticky bone graft material
Active Comparator group
Description:
The piezoelectric surgical sets comprise various inserts from osteotomies to diamond-cutting inserts. The hydropneumatics pressure of the saline solution irrigation is subjected to the piezoelectric cavitation pushing the Schneiderian membrane upwards resulting in its' detachment and floating
Treatment:
Procedure: piezoelectric internal sinus lift / sticky bone graft material

Trial contacts and locations

1

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Central trial contact

Mohammed Samir, BDs

Data sourced from clinicaltrials.gov

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