Assessment of the Effect of an Implant System With a Novel Abutment Attachment Design on Crestal Bone Preservation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2016-12-31

Brief Summary

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Integration success rates and the preservation of crestal bone will be higher for the experimental device than for the control implants.

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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 lack of implant mobility and lack of bone loss obtained at various study time points

Conditions

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Partial Edentulism Tooth Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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New abutment connection implant

Implant with new abutment connection

Group Type EXPERIMENTAL

New Abutment Connection implant

Intervention Type DEVICE

New abutment connection implant

Nanotite Certain Tapered implant

Nanotite Certain Tapered (standard abutment connection) implant

Group Type ACTIVE_COMPARATOR

Nanotite Certain Tapered implant

Intervention Type DEVICE

Nanotite Certain Tapered (standard abutment connection) implant

Interventions

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New Abutment Connection implant

New abutment connection implant

Intervention Type DEVICE

Nanotite Certain Tapered implant

Nanotite Certain Tapered (standard abutment connection) implant

Intervention Type DEVICE

Other Intervention Names

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Osseotite Endosseous dental implant Nanotite endosseous dental implant

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No