Osseodensification by Densah Burs Versus Osteotome

Study Overview
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Brief Summary
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implant placement in the posterior maxilla is problematic, not only due to inferior properties of bone but also due to loss of vertical bone height which happens after extraction of posterior teeth. when the required additional height is few millimeters, indirect transcresta sinus lifting procedures are recommended. This study compares sinus lifting using the conventional osteotome versus the osseodensification with densah burs.

Detailed Description
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a total of 12 patients with missing maxillary premolars or molars and with limited vertical bone height below the maxillary sinus floor will receive implants either with osteotome or with Densah burs transcrestal sinus lifting to compare clinically and radiographically transcrestal sinus lifting with Densah burs and osteotome with simultaneous implant placement

Official Title
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Osseodensification by Densah Burs Versus Osteotome for Transcrestal Maxillary Sinus Lifting With Simultaneous Implant Placement (Randomized Clinical Trial)

Conditions
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Maxillary Sinus Lift

Intervention / Treatment
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* Procedure: oseodensification sinus lifting
* Procedure: osteotome sinus lifting


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with missing maxillary premolas and molars Vertical bone height of 5-8 mm Non smokers Good oral hygiene Exclusion Criteria: Bad oral hygiene maxillary sinusitis Presence of infection or periapical lesions in adjacent teeth Bruxism or clenching Alcoholism Medically compromised patients with a condition that affect the procedure Multiple sinus septa

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 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 |
| --- | --- |
| Active Comparator: osteotome sinus lifting<br> | Procedure: osteotome sinus lifting<br>* drilling implant site with consecutive drills short of the sinus floor by 1-2mm , using osteotome in appropriate size and application of one tap until sinus floor is elevated, using the final drill for the desired implant diameter<br>|
| Experimental: oseodensification sinus lifting<br> | Procedure: oseodensification sinus lifting<br>* application of first densah bur with densifying mood (reverse) counterclockwise, 1200 revolution per minute until the sinus is reached then use a wider densah bur with the same mode and bouncing motion to elevate the sinus floor up to 3 mm in 1mm increments.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| implant stability | Using the Osstell, The result is presented as an ISQ value of 1-100. The higher the ISQ, the more stable the implant | at 6 months | 
| change in bone height | using CBCT | at baseline and 6 months | 
| change in bone density | using CBCT | at baseline and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain scores | 10-point Visual Analogue Scale (VAS). (0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe) | at 2 weeks | 
| edema scores | The pitting is graded on a scale of +1 to +4 as follows: +1 (trace) slight indentation rapid return to normal. +2 (mild) the indentation returns to normal in a few seconds. +3 (moderate) 6 mm indentation rebounds in 10-20 seconds. +4 (severe) 8 mm indentation rebounds in more than 30 seconds. | at 2 weeks |