Densah Burs vs. Electrical Mallet in Closed Sinus Lifting.

Study Overview
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Brief Summary
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The aim of the comparative study is to evaluate the density and amount of new bone formed (bone height gain)around dental implant placed simultaneously in posterior maxilla after closed sinus floor elevation using Osseodensification burs versus electrical mallet.

Detailed Description
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Extraction of posterior teeth in the maxilla for long time without rehabilitation of the area increases the incidence of maxillary sinus pneumatization that makes maxillary sinus enlarges in volume over the residual bone of alveolar ridge. Decreasing the height of sub_ antral bone affects adversely on the bone density which is crucial for implant primary stability causing placement of dental implant quite challenging requiring sinus lifting procedure and bone condensation of residual ridge in addition to bone grafting Summers technique considered the gold standard for closed sinus floor elevation using osteotome and a hand mallet to condense alveolar bone and elevate schneiderian membrane. One of drawbacks of this technique is benign paroxysmal positional vertigo due to force applied by hand mallet is not controlled. Electrical mallet was introduced to overcome (BPPV) as it applies controlled force (daN) in short fraction of seconds(µs) with hand piece secured totally by the surgeon and have a wide variety of instruments placed on the hand piece e.g. osteotomes used in sinus floor elevation . Controlled force of magnetic mallet decrees the risk of schneiderian membrane perforation Osseodensification burs now show great outcomes in closed sinus lifting procedure. Densah burs increase the density of alveolar bone which increase the primary stability of dental implants . Aim of this study is to compare Electrical mallet with Osseodensification burs in closed sinus lifting.

Official Title
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Radiographic and Clinical Comparative Study Between Osseodensification Burs and Electrical Mallet in Closed Sinus Floor Elevation and Simultaneous Implant Placement. Prospective Clinical Trial.

Conditions
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Alveolar Bone Loss

Intervention / Treatment
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* Device: Electrical mallet
* Device: Osseo-densification burs


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with partially edentulous posterior maxilla Residual bone height ≥ 5mm Oral hygiene : fair oral hygiene Exclusion Criteria: Smoking Systematic disease that affects bone remodeling (e.g. uncontrolled Diabetes mellitus or osteoporosis) Radiotherapy to head and neck or chemotherapy Chronic disease of maxillary sinus

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: group I (Osseo Densification group) Patients in this group will have sinus floor elevation using osseodensification burs then application of PRF membrane through the socket to protect schneiderian membrane and application of sticky bone (xeno graft and i-PRF) to augment alveolar ridge to receive dental implant group II (electrical mallet group) Patients in this group will have sinus floor elevation using electrical mallet then application of PRF membrane through the socket to protect schneiderian membrane and application of sticky bone (xeno graft and i-PRF) to augment alveolar ridge to receive dental implant
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Osseo-densification group<br> | Device: Osseo-densification burs<br>* elevation of the Schneiderian membrane of maxillary sinus using osseodensification burs and place bone graft material to augment the residual alveolar ridge and then place dental implant .<br>|
| Active Comparator: Electrical mallet group<br> | Device: Electrical mallet<br>* elevation of the Schneiderian membrane of maxillary sinus using electrical mallet and place bone graft material to augment the residual alveolar ridge and then place dental implant .<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bone height gain | Evaluate the change in bone height radiographically after closed sinus floor elevation and simultaneous implant placement .using cone beam computed tomography immediate after surgery and 6 months post operative . | 6 months follow up | 
| change in bone density | Evaluate the amount of change in bone density around dental implant immediately post operative and after 6 months. | 6 months follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sinus lift, electrical mallet, osseodensification, bone density