Osseodensification Versus Motor-Driven Expanders' Techniques for Increasing Bone Density With Simultaneous Implant Placement

Study Overview
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Brief Summary
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The aim of this study was to compare and measure the amount of bone density and ridge width gained with motor driven expanders and densifying burs with simultaneous dental implant placement.

Detailed Description
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Seven patients were treated by the osseodensification technique and another seven were treated by the motor-driven expanders' technique with simultaneous implant placement.

Official Title
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Osseodensification Versus Motor-Driven Expanders' Techniques for Increasing Bone Density With Simultaneous Implant Placement (Randomized Controlled Clinical Trial)

Conditions
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Alveolar Bone Loss

Intervention / Treatment
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* Procedure: Osseodensification technique
* Procedure: Motor driven expanders' technique


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients requiring implant placement in the anterior maxilla until the premolar region. Patients are medically fit. The width of the deficient maxillary alveolar ridge not less than 3mm. Patients willing and fully capable to comply with the study protocol. Exclusion Criteria: Atrophic ridge (2 mm or less) with no interposition of cancellous bone between the buccal and palatal plates. Uncontrolled metabolic disease (e.g. uncontrolled diabetes). Heavy smokers (>15 cigarettes/day). Acute oral infections. Untreated periodontal disease. Poor oral hygiene. Pregnant or breastfeeding patient. A history of radiotherapy to the head and neck region or treatment with bisphosphonates. Female patients using oral contraceptive pills. Presence of oral parafunctional habits. Surgical site needs to be grafted.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 45 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Osseodensification technique<br> | Procedure: Osseodensification technique<br>* Implant bed preparation will be performed according to the manufacturer's guidelines, densifying burs (Densah® Burs) will be used sequentially in densifying mode (counterclockwise drill speed 800-1500 rpm with copious irrigation) to achieve the planned osteotomy diameter and desired ridge expansion. The implant will be then placed in the prepared osteotomy<br>|
| Active Comparator: Motor driven expanders' technique<br> | Procedure: Motor driven expanders' technique<br>* The technique consisted of preparing the implant bed by progressively increasing the size of the osteotomes until the desired expansion will be achieved. At the planned implant site, a pilot drill 1000 rpm with irrigation until the desired length, then expansion with the series of ridge spreaders and finally using the final drill. The implant will be then placed in the prepared osteotomy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative pain | Pain was assessed using a 10-point Visual Analogue Scale (VAS). The lower values indicates lower pain levels and higher values indicates higher pain levels | up to 1 month | 
| Implant stability | Stability was assessed using resonance frequency analysis measured with the Osstell device instrument. The Osstell unit records a numeric value of 1-100 which is referred to as the implant stability quotient (ISQ). The measurements were performed and 3 mean of three readings were recorded. | up to 6 months | 
| Bone density | This will be assessed using cone beam computed tomography (CBCT) | up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endosseous implants, Osseodensification