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)
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Cairo, Egypt
- AinShams university
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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.
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: osseodensifiction internal sinus lift / sticky bone graft material
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.
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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.
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Active Comparator: piezoelectric internal sinus lift / sticky bone graft material
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
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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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Radiographic assessment of change in the vertical bone height (bone gain)
Time Frame: per-operative and immediately post-operative
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Immediate postoperative CBCTs will be taken to all participants to assess bone gain .
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per-operative and immediately post-operative
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Radiographic assessment of bone density
Time Frame: per-operative and immediately post-operative
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Immediate postoperative CBCTs will be taken to all participants to assess bone density.
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per-operative and immediately post-operative
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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implant primary stability (insertion torque )
Time Frame: during procedure
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implant insertion torque will be assessed using torque wrench .
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during procedure
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implant primary stability (ISQ)
Time Frame: during procedure
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implant stability quotient will be assessed using Osstell device
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during procedure
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patient post-operative pain assessment
Time Frame: 1 week post-operative
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obtained using a 100 mm visual analogue scale
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1 week post-operative
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patient's satisfaction assessment
Time Frame: 1 week post-operative
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obtained by the aid of a health-related quality of life questionnaire
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1 week post-operative
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operator's satisfaction assessment
Time Frame: 1 year
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obtained by the aid of a questionnaire assessing the operator's satisfaction
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1 year
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mohammed Samir, BDs, AinShams university
Publications and helpful links
General Publications
- Pjetursson BE, Lang NP. Sinus floor elevation utilizing the transalveolar approach. Periodontol 2000. 2014 Oct;66(1):59-71. doi: 10.1111/prd.12043.
- Huwais S, Mazor Z, Ioannou AL, Gluckman H, Neiva R. A Multicenter Retrospective Clinical Study with Up-to-5-Year Follow-up Utilizing a Method that Enhances Bone Density and Allows for Transcrestal Sinus Augmentation Through Compaction Grafting. Int J Oral Maxillofac Implants. 2018 Nov/Dec;33(6):1305-1311. doi: 10.11607/jomi.6770.
- Torrella F, Pitarch J, Cabanes G, Anitua E. Ultrasonic ostectomy for the surgical approach of the maxillary sinus: a technical note. Int J Oral Maxillofac Implants. 1998 Sep-Oct;13(5):697-700.
- Li J, Lee K, Chen H, Ou G. Piezoelectric surgery in maxillary sinus floor elevation with hydraulic pressure for xenograft and simultaneous implant placement. J Prosthet Dent. 2013 Nov;110(5):344-8. doi: 10.1016/j.prosdent.2013.04.002. Epub 2013 Sep 29.
- Mourao CF, Valiense H, Melo ER, Mourao NB, Maia MD. Obtention of injectable platelets rich-fibrin (i-PRF) and its polymerization with bone graft: technical note. Rev Col Bras Cir. 2015 Nov-Dec;42(6):421-3. doi: 10.1590/0100-69912015006013. English, Portuguese.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- FDASU_Rec IM 122215
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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