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Completed

NCT Number: NCT06055127

Osseodensifiction Versus Piezoelectric Internal Sinus Elevation Technique in Delayed Implant Placement

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.

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Key information

Conditions

Maxillary Sinus Floor Augmentation

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AinShams University

Cairo, Egypt

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patient partially edentulous with maxillary posterior edentulous ridge after extraction of more than 4 months.
  • Both sexes will be selected males and females.
  • Adult patients aged between 18 and 40 years of age.
  • Good general health (American Society of Anesthesiology Physical Status Ⅰ-Ⅱ).
  • Initial residual alveolar ridge height ranging between 4 to 6 mm according to preoperative CBCT.
  • 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.
  • Medical conditions affecting bone metabolism and ongoing treatment with bisphosphonates drugs or systemic steroids.
  • Presence of acute or chronic sinus pathoses or sinus membrane perforation.

Treatment and study plan

osseodensifiction internal sinus lift / sticky bone graft material

Procedure

The osteotomy for the osseodensification internal sinus lift begins with a twist drill advanced at 800 rpm with saline irrigation to within 1-2 mm from the sinus floor. Next, a series of osteotomy drills are used in the same fashion at 800 rpm to widen the osteotomy. The final osteotomy drill is advanced with gentle pressure at 100 rpm counterclockwise without irrigation until a bouncing sensation occurs "haptic feedback" at this point infracture of the sinus has taken place. After infracture, injection of the graft material into the osteotomy site will occur. The final osteotomy drill is used to guide the graft apically. This process is repeated in an incremental fashion to lift the membrane. Once enough space has been created below the antral membrane, implant insertion will occur then suturing.

piezoelectric internal sinus lift / sticky bone graft material

Procedure

In the PISE technique, an ultrasonic piezoelectric device (acteon), to which a specialized tip is attached, is used to break the sinus floor. Developed for sinus lift by the crestal approach, the Intralift™ Kit makes it possible to undertake dental non invasive surgery in full safety.

The diamond-coated tips, of increasing diameters (from 1.35mm to 2.80mm), are designed to drill and gradually widen the access canal to the sinus membrane. The sterile spray cools the tips down to avoid any rise in temperature, which could lead to oral tissue damage.The membrane elevation is achieved using the TKW5 by means of microcavitation. Thanks to the ultrasonic frequency modulation, the risk of membrane damage is limited. Moreover, the cavitation effect enables excellent visibility of the operating field.

Primary outcomes

  1. Radiographic assessment of change in the vertical bone height (bone gain)

    Time frame: per-operative and immediately post-operative

    Immediate postoperative CBCTs will be taken to all participants to assess bone gain .

  2. Radiographic assessment of bone density

    Time frame: per-operative and immediately post-operative

    Immediate postoperative CBCTs will be taken to all participants to assess bone density.

Secondary outcomes

  1. implant primary stability (insertion torque )

    Time frame: during procedure

    implant insertion torque will be assessed using torque wrench .

  2. implant primary stability (ISQ)

    Time frame: during procedure

    implant stability quotient will be assessed using Osstell device

  3. patient post-operative pain assessment

    Time frame: 1 week post-operative

    obtained using a 100 mm visual analogue scale

  4. patient's satisfaction assessment

    Time frame: 1 week post-operative

    obtained by the aid of a health-related quality of life questionnaire

  5. operator's satisfaction assessment

    Time frame: 1 year

    obtained by the aid of a questionnaire assessing the operator's satisfaction

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Osseodensifiction Versus Piezoelectric Internal Sinus Elevation (PISE) Technique in Delayed Implant Placement (A Randomized Controlled Clinical Trial)

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 26, 2023
Registry last updated
Jul 31, 2024

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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