Implant Primary Stability and Ridge Dimensional Changes Utilizing the Osseodensification Protocol

Study Overview
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Brief Summary
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The purpose of this study is to compare ridge dimensional changes between densification and standard drilling protocols and to compare primary and secondary stability of implants placed by bone densification and standard drilling protocols

Official Title
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Implant Primary Stability and Ridge Dimensional Changes Utilizing the Osseodensification Protocol

Conditions
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Dental Implants

Intervention / Treatment
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* Device: OsseoDensification (OD) protocol
* Device: standard drilling (SD) protocol (NobelReplace® Conical)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who understand and agree to this study. Adequate Oral hygiene One or more edentulous spaces, which are 10 weeks or longer after extractions Exclusion Criteria: Pregnancy. Smoking of more than 5 cigarettes/day. History of alcoholism or drug abuse during the last 5 years. Uncontrolled Hypertension or diabetes. Patient with malignant tumor. Patients on daily dose of steroids. Patients with history of chemotherapy or radiation for the last 12 months.

Ages Eligible for Study
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Minimum Age: 22 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: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OsseoDensification (OD) protocol<br> | Device: OsseoDensification (OD) protocol<br>* Osseodensification is a drilling process by which bone is being compacted and auto-grafted in an outwardly expanding direction from the osteotomy. When the osseodensification drills are being rotated in a reversed, non-cutting direction a strong and dense layer of bone is formed along the walls and base of the osteotomy.<br>|
| Active Comparator: standard drilling (SD) protocol<br> | Device: standard drilling (SD) protocol (NobelReplace® Conical)<br>* osteotomy preparation through bone excavation is necessary in implant site development for the placement of dental implants. The process involves a forward cutting process with removal of bone tissue creating appropriate size osteotomy for the dental implant.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in bone ridge width at crest | bone ridge width will be measured using a Mitutoyo Digimatic Caliper | day of implant surgery | 
| Change in bone ridge width at 5mm apical from crest | bone ridge width will be measured using a Mitutoyo Digimatic Caliper | day of implant surgery | 
| Change in bone ridge width at 10mm apical from crest | bone ridge width will be measured using a Mitutoyo Digimatic Caliper | day of implant surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary stability of the implants as measured by the insertion torque values |  | day of implant surgery | 
| Change in primary stability of the implants as indicated by the implant stability quotient (ISQ) as measured by the resonance frequency analysis using the Ostell ISQ meter |  | baseline(after implant placement),3 weeks after implant placement and 6 weeks after implant placement | 
| volume of the ridge as assessed by the Cone beam computer tomography (CBCT) |  | 6 months post implantation | 
| buccolingual width of the ridge as assessed by the Cone beam computer tomography (CBCT) |  | 6 months post implantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osseodensification, ridge expansion