Assessment of Integration Success of an Implant System With a Novel Abutment Attachment Design in Early Loaded Cases

Study Overview
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Brief Summary
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Integration success rates measured by resistance to countertorque testing will be higher for the experimental implant design than for the control implants.

Detailed Description
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In this study patients are randomized to receive either the experimental implant system or the control Nanotite Certain Tapered (standard abutment connection) and assessed for integration success measured by countertorque testing and cumulative success rate in cases that are loaded early

Official Title
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A Prospective Randomized-controlled Study of the Integration Success Rate of an Implant System With a Novel Abutment Attachment in Cases Loaded Early

Conditions
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Partial Edentulism, Tooth Disease

Intervention / Treatment
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* Device: Implant with new abutment connection
* Device: Nanotite Certain Tapered implant


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: New abutment connection implant<br>Implant with new abutment connection | Device: Implant with new abutment connection<br>* New abutment connection implant system<br>* Other names: Osseotite Endosseous dental implant;|
| Active Comparator: Nanotite Certain Tapered implant<br>Nanotite Certain Tapered (standard abutment connection) implant | Device: Nanotite Certain Tapered implant<br>* Nanotite Certain Tapered (standard abutment connection) implant<br>* Other names: Nanotite 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 | 2 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) | 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, Nanotite Certain Tapered implant, randomized, crestal bone level, early loading