Randomized Study of Integration Success of Osseotite Dental Implants Placed Using Different Insertion Procedures

Study Overview
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Brief Summary
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Osseotite implants placed with higher insertion torque (TEST procedure) will have higher initial stability and integration success than those placed with lower insertion torque forces.

Detailed Description
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Osseotite implants will be placed using the standard lower insertion torque forces and compared to implants placed using higher insertion torque forces.

Official Title
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Prospective Randomized-controlled Study of the Integration Success of Osseotite Implants Placed With Different Insertion Procedures

Conditions
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Partial Edentulism, Tooth Disease

Intervention / Treatment
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* Procedure: High torque insertion
* Procedure: Low torque insertion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients of either sex and older than 18 years of age patients needing a minimum of 3 implants to treat partial edentulism patients physically able to tolerate surgical and restorative dental procedures patients agreeing to all protocol visits Exclusion Criteria: patients with infection or severe inflammation at the intended treatment sites patients smoking greater than 10 cigarettes per day patients with uncontrolled diabetes mellitus patients with uncontrolled metabolic diseases patients who received radiation treatment to the head in the past 12 months patients needing bone grafting at the intended treatment sites patients known to be pregnant at screening visit patients with para-functional habits like bruxing and clenching

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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High torque insertion<br>High torque insertion | Procedure: High torque insertion<br>* Osseotite implant placed with high insertion torque forces<br>* Other names: Osseotite endosseous dental implant;|
| Active Comparator: Low torque insertion<br>Low torque insertion | Procedure: Low torque insertion<br>* Osseotite implant placed with low insertion torque forces<br>* Other names: Osseotite endosseous dental implant;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| primary stability countertorque measures | resistance to countertorque measures showing primary stability success of implants | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cumulative success rate | Crestal bone regression (amount of bone loss measured) and equivalence in integration success (implant mobility) | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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edentulism, dental implants, early loading, crestal bone level, high torque insertion, low torque insertion, randomized, Osseotite, clinical study