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Isolated sinus pneumatization after single tooth extraction indicate sinus lifting for proper implant placement. The conventional way of using osteotomes to elevate the sinus is annoying to patient and also does not give the needed amount of bone around the implant. Introducing new intervention of Densah Burs helps increase bone gain around implant and decrease the patient discomfort.
The rehabilitation of the edentulous posterior maxilla using osseointegrated implants is often challenging due alveolar bone resorption, low bone density and maxillary sinus pneumatization. Maxillary sinus lift is one of the most common surgical techniques used for increasing the available bone volume to place implants and restore function and esthetics. Trans-crestal approach can be successfully adopted when residual bone height is at least 5 mm. Osteotome sinus floor elevation was first in 1994, and proved to be less invasive, more conservative, less time consuming, and reduces postoperative discomfort to the patient. Moreover, this technique was found to yield predictable results with success rates of at least 95%.
Osseodensification is a new surgical technique of biomechanical bone preparation performed for dental implant placement where bone is compacted and auto grafted into open marrow spaces and osteotomy site walls in outwardly expanding directions. It was reported that osseodensification increases the bone-implant contact, bone density, and primary stability. Moreover, the insertion torque peak is directly related to implant primary stability and host bone density. Furthermore, for every 9.8 N cm of torque increased, a reduction in failure rate of 20% in single-tooth implant restoration was observed.
The objective of this study is to evaluate crestal sinus elevation using osseodensification versus osteotomy clinically and radiographically in terms of marginal bone loss, primary and secondary stability and bone gain around the implant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Closed sinus lift using Densah bur | Active Comparator | Closed sinus lifting will be performed using densah burs and then dental implants will be placed. |
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| Conventional closed sinus lift using osteotomes | Active Comparator | Sinus lifting will be performed using osteotomes and then dental implants will be placed. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Use of Densah Burs in closed sinus lift | Procedure | Closed sinus will be performed using Densah Burs. Densah Burs enhance bone quality through osseodensification; a process through which bone is compacted and auto-graphted in the marrow spaces and apically to elevate the sinus floor and enhance bone density. |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of Bone Change in Cone Beam CT | The amount of bone change will be determined by superimposing pre-operative CBCT (cone-beam computed tomography), three months post-operative, and six months post-operative CBCT. | three and six months |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of Primary and Secondary Implant stability using Resonance Frequency Analysis (RFA) | The implant stability quotient (ISQ) of the implants will be measured using a resonance frequency analysis measuring device, that is, Ostell, at the time of placement, which is the primary stability, and after six months, which is the secondary stability. The implant stability quotient has a scale ranging from 0 to 100 in which 0 is a failed implant and 100 is maximum implant stability. |
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Inclusion Criteria:
Exclusion Criteria:
Remaining alveolar ridge height is less than 5mm
Patients should not have taken drugs, especially bisphosphonates or drugs altering bone metabolism, within 2 months before the inclusion in the study.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eman M Anwar, Professor | Contact | +20223642705 | 522 | rec@dentistry.cu.edu.eg |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16274152 | Background | Ottoni JM, Oliveira ZF, Mansini R, Cabral AM. Correlation between placement torque and survival of single-tooth implants. Int J Oral Maxillofac Implants. 2005 Sep-Oct;20(5):769-76. | |
| 8055503 | Background | Summers RB. A new concept in maxillary implant surgery: the osteotome technique. Compendium. 1994 Feb;15(2):152, 154-6, 158 passim; quiz 162. |
| Label | URL |
|---|---|
| Clinical and radiographic evaluation of osseodensification versus osteotome for sinus floor elevation in partially atrophic maxilla: A prospective long term study | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 26, 2021 | Aug 20, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 26, 2021 | Aug 20, 2022 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 26, 2021 | Aug 20, 2022 | ICF_002.pdf |
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Patients' data will be enrolled in database of the Outpatient clinics of the Department of Oral and maxillofacial surgery, Faculty of Dentistry, Cairo University. If there is a potential eligibility, the patient will be examined thoroughly as described before. Consecutive sampling is done through screening of patients. This will continue until the target population is achieved. Identifying and recruiting potential subjects is achieved through patient database.
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This trial is considered a randomized double blind clinical trial due to the following:
The purpose of double blinding procedure is to reduce assessment bias and to increase accuracy and objectivity of clinical outcomes
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| Closed sinus lift using osteotomes | Procedure | Closed sinus lift will be performed using osteotomes. Osteotomes elevate the sinus floor and enhance the bone quality. |
|
| At the day of implant placement and after six months |
| Primary Stability of Implant in Closed Sinus Lifting Cases Using Densah Bur Versus Osteotome | View source |
| Patient Perception and Radiographic Assessment of Sinus Lifting Procedure using Densah Bur versus Osteotome-mediated sinus lifting: A Randomized Clinical Trial | View source |