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Osseodensifiction Versus Piezoelectric Internal Sinus Elevation Technique in Delayed Implant Placement

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06055127
Enrollment
16
Registered
2023-09-26
Start date
2023-09-08
Completion date
2024-05-31
Last updated
2024-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Maxillary Sinus Floor Augmentation

Keywords

internal sinus elevation, osseodensfication,, piezoelectric surgery

Brief summary

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.

Interventions

PROCEDUREosseodensifiction internal sinus lift / sticky bone graft material

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.

PROCEDUREpiezoelectric internal sinus lift / sticky bone graft material

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.

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

computer-generated randomization table

Intervention model description

parallel single blind masking randomized controlled clinical trail

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

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. 7\. Medical conditions affecting bone metabolism and ongoing treatment with bisphosphonates drugs or systemic steroids. 8\. Presence of acute or chronic sinus pathoses or sinus membrane perforation.

Design outcomes

Primary

MeasureTime frameDescription
Radiographic assessment of change in the vertical bone height (bone gain)per-operative and immediately post-operativeImmediate postoperative CBCTs will be taken to all participants to assess bone gain .
Radiographic assessment of bone densityper-operative and immediately post-operativeImmediate postoperative CBCTs will be taken to all participants to assess bone density.

Secondary

MeasureTime frameDescription
patient post-operative pain assessment1 week post-operativeobtained using a 100 mm visual analogue scale
implant primary stability (insertion torque )during procedureimplant insertion torque will be assessed using torque wrench .
operator's satisfaction assessment1 yearobtained by the aid of a questionnaire assessing the operator's satisfaction
patient's satisfaction assessment1 week post-operativeobtained by the aid of a health-related quality of life questionnaire
implant primary stability (ISQ)during procedureimplant stability quotient will be assessed using Osstell device

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026