Primary Stability of Implant in Closed Sinus Lifting Cases Using Densah Bur Versus Osteotome

Study Overview
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Brief Summary
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This study is aiming to evaluate primary stability of implant in closed sinus lifting cases by Densah bur in compared to Osteotome in partially edentulous patients hoping that densah bur can lift the sinus membrane and improve primary stability of implant.

Detailed Description
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The osteotome technique is effective in certain cases, but the most sensitive aspect is the tapping force, which should be sufficient enough to infracture the sinus floor cortical bone but restrained enough to prevent the osteotome tip from traumatizing the Schneiderian membrane. Several surgical techniques have been proposed to minimize the sinus membrane perforation rate by using a piezosurgical device, balloon, hydrostatic pressure. The success of therapy in posterior maxilla is not only dependent on the success of the sinus elevation but also the primary stability of the implant that allow bone apposition on the implant surface without any micromovement for osseeointegration. Later, densah burs are introduced as another treatment option for internal transalveolar approach of sinus floor elevation with improving primary stability of implant by osseodensification. As treatment options of edentulous maxillary today may include dental implants, the practitioner must be familiar with various sinus lift surgical techniques in order to choose an ideal treatment option for the patient.

Official Title
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Evaluation for Primary Stability of Implant in Closed Sinus Lifting Cases Using Densah Bur Versus Osteotome in Partially Edentulous Patients (A Randomized Clinical Trial)

Conditions
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Sinus Pneumatization

Intervention / Treatment
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* Other: closed sinus lifting by Osteotome
* Other: closed sinus lifting by Densah bur


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Both males as well as females without any active periodontal disease. All patients were in a good health with no systemic diseases. All selected patients were non-smokers and non-alcoholics. Patient were free from T.M.J troubles, abnormal oral habits such as bruxism. The edentulous ridges were covered with optimal thickness of soft tissue. Remaining natural teeth had good. Periodontal tissue support and occlusion showed sufficient inter arch space. On the local level, patients with maxillary sinus diseases and unfavorable inter maxillary relationship were excluded. Exclusion Criteria: Patients with residual bone height less than 6mm. Patients with systemic disease that may affect bone quality. Patients with poor oral hygiene and active periodontal diseases. Patient with limited mouth opening.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The patients will be randomly divided into 2 equal groups
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: closed sinus lifting by Osteotome<br>Local anesthesia will be injected intra-orally A full thickness flap will be elevated A pilot drill will be used to start the osteotomy preparation, which should be ended 1mm short of sinus floor. The widening drills can be sequentially used to widen the osteotomy site to the same level An osteotome of diameter a little less than the planned implant body, will be inserted in the prepared osteotomy site and gently tapped to reach the same level. The osteotome will be tapped gently to fracture up the sinus floor. Xenograft will be added to the osteotomy as the grafting material. Once the desired height of sinus elevation will be gained and grafted, the implant fixture will be inserted. Smart peg will be placed on implant and Ostell will be used to record ISQ. Healing collar will be placed on implant. Suturing the flab around healing collar. | Other: closed sinus lifting by Osteotome<br>* Local anesthesia will be injected intra-orally A full thickness flap will be elevated A pilot drill will be used to start the osteotomy preparation, which should be ended 1mm short of sinus floor. The widening drills can be sequentially used to widen the osteotomy site to the same level An osteotome of diameter a little less than the planned implant body, will be inserted in the prepared osteotomy site and gently tapped to reach the same level. The osteotome will be tapped gently to fracture up the sinus floor. Xenograft will be added to the osteotomy as the grafting material. Once the desired height of sinus elevation will be gained and grafted, the implant fixture will be inserted. Smart peg will be placed on implant and Ostell will be used to record ISQ. Healing collar will be placed on implant. Suturing the flab around healing collar.<br>|
| Experimental: closed sinus lifting by Densah bur<br>Local anesthesia will be injected intra-orally A full thickness flap will be elevated A pilot drill will be used to start the osteotomy , which should be ended 1mm short of sinus floor. Change the drill motor to reverse- densifying Mode Begin with the densah bur (2.5mm) until 1 mm short of the sinus floor. Use the next wider Densah Bur (3.0) in densifying-mode until feeling the haptic feedback of the bur reaching the dense sinus floor, modulate pressure with a gentle pumping motion to advance past the sinus floor in 1 mm increments. densah burs (3.5mm) advance in the osteotomy. Xenograft will be added to the osteotomy . Once the desired height of sinus elevation will be gained and grafted, the implant fixture will be inserted. Smart peg will be placed on implant and Ostell will be used to record ISQ. Healing collar will be placed on implant. Suturing the flab around healing collar. | Other: closed sinus lifting by Densah bur<br>* Local anesthesia will be injected intra-orally A full thickness flap will be elevated A pilot drill will be used to start the osteotomy , which should be ended 1mm short of sinus floor. Change the drill motor to reverse- densifying Mode with the densah bur (2.5mm) until 1 mm short of the sinus floor. Use the next wider Densah Bur (3.0) in densifying-mode until feeling the haptic feedback of the bur reaching the dense sinus floor, modulate pressure with a gentle pumping motion to advance past the sinus floor in 1 mm increments. densah burs (3.5mm) advance in the osteotomy. Xenograft will be added to the osteotomy . Once the desired height of sinus elevation will be gained and grafted, the implant fixture will be inserted. Smart peg will be placed on implant and Ostell will be used to record ISQ. Healing collar will be placed on implant. Suturing the flab around healing collar.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stability of implant | After implant placement, Implant stability will be measured by Ostell | Implant stability will be measured intraoperative at time of surgery | 
| stability of implant | Implant stability will be measured by Ostell | Implant stability will be measured at second week | 
| stability of implant | Implant stability will be measured by Ostell | Implant stability will be measured at fourth week | 
| stability of implant | Implant stability will be measured by Ostell | Implant stability will be measured at the sixth week | 
| stability of implant | Implant stability will be measured by Ostell | Implant stability will be measured at The eighth week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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closed sinus lifiting, implant stability, osteotome, densah bur