Assessment of the Effect of a Novel Surface Roughness Treatment on Dental Implants on Integration Success

Study Overview
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Brief Summary
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A study where dental implants with different roughened surfaces will be evaluated for the ability to resist countertorque forces.

Detailed Description
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This study on dental implants with different roughened surfaces will assess its ability to resist countertorque testing at various study time points and demonstrate high success

Official Title
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A Prospective Randomized-controlled Study of the Effect of Surface Topographies on Implant Integration Rates and Clinical Success

Conditions
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Partial Edentulism, Tooth Disease

Intervention / Treatment
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* Device: Osseotite Certain Tapered Group A
* Device: Osseotite Certain Tapered Group B
* Device: Osseotite Certain Tapered Group C


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 at least one dental implant 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: Roughness group A<br>Osseotite Certain Tapered Group A | Device: Osseotite Certain Tapered Group A<br>* Osseotite Certain Tapered with different surface roughness<br>* Other names: Osseotite endosseous dental implant;|
| Experimental: Roughness Group B<br>Osseotite Certain Tapered Group B | Device: Osseotite Certain Tapered Group B<br>* Osseotite Certain Tapered with different surface roughness<br>* Other names: Osseotite endosseous dental implant;|
| Experimental: Roughness Group C<br>Osseotite Certain Tapered Group C | Device: Osseotite Certain Tapered Group C<br>* Osseotite Certain Tapered with different surface roughness<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 and success of the implant | 6 weeks | 

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) | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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edentulism, dental implants, clinical study, randomized, Osseotite Certain Tapered, Crestal bone level