Study Comparing Appearance and Function of Three Different Dental Implant Designs When Placed in Front Region of Upper Jaw

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

141 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2016-09-30

Brief Summary

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The primary objective is to compare the gum response to three different dental implant designs when placed in the front region of the upper jaw. The changes from baseline to one year after will be compared. The null-hypothesis is that the buccal soft tissue (gum) changes from baseline to one year after are equal for all three implant-abutment interface settings.

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Detailed Description

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Conditions

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Jaw, Edentulous, Partially

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type EXPERIMENTAL

OsseoSpeed™

Intervention Type DEVICE

OsseoSpeed™ implant

B

Group Type ACTIVE_COMPARATOR

NobelSpeedy™ Replace®

Intervention Type DEVICE

NobelSpeedy™ Replace® implant

C

Group Type ACTIVE_COMPARATOR

NanoTite™ Certain® PREVAIL®

Intervention Type DEVICE

NanoTite™ Certain® PREVAIL® implant

Interventions

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OsseoSpeed™

OsseoSpeed™ implant

Intervention Type DEVICE

NobelSpeedy™ Replace®

NobelSpeedy™ Replace® implant

Intervention Type DEVICE

NanoTite™ Certain® PREVAIL®

NanoTite™ Certain® PREVAIL® implant

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Provision of informed consent
* At least 18 years
* In need of one or more single implants replacing missing or non-restorable teeth in the maxilla within region 14 to 24

The following should be considered at inclusion but can not be fulfilled until at Visit 2:

* Edentulous for at least 5 months at study site
* A buccal-lingual bone width at study site of at least 5.5 mm
* A mesial-distal bone level distance between adjacent teeth at study site of at least 5.5 mm
* A keratinized mid-buccal mucosal height of at least 2 mm at study site
* Teeth adjacent (mesial and distal) to study site must consist of two stable teeth on natural roots without signs of periodontal bone loss (\>1 mm) and/or significant soft tissue loss
* Teeth adjacent (mesial and distal) to study site must demonstrate a stable occlusal guidance that will allow non-functional disclusion in all eccentric positions
* An opposing dentition with teeth, implants or prosthesis

Exclusion Criteria

* Insufficient interocclusal distance for implant placement and restoration at study site
* Tooth adjacent (mesial and/or distal) to study site is ankylosed
* More than 2 mm vertical bone loss at study site as measured from the mid-buccal crest of bone on the adjacent teeth
* Site development (bone tissue) performed at less than 5 months before Visit 2 at study site
* Untreated rampant caries and/or uncontrolled periodontal disease
* Class II division 2 malocclusion (Edward Hartley Angle)
* Use of tobacco within last 6 months
* Uncontrolled diabetes (subjects history does not reveal the absence of control of insulin-dependent/non-insulin dependent Diabetes Mellitus)
* Current alcohol or drug abuse
* Systemic or local disease or condition that would compromise post-operative healing and/or osseointegration
* Use of any substance that will influence bone metabolism
* Need for systemic corticosteroids or any other medication that would influence post-operative healing and/or osseointegration
* History of radiation in the head and neck region
* Known pregnancy, pregnancy tests will be performed as per local requirements.
* Unable or unwilling to return for follow-up visits for a period of 5 years
* Unlikely to be able to comply with study procedures according to Investigators judgement
* Involvement in the planning and conduct of the study (applies to both Astra Tech staff or staff at the study center)
* Previous enrollment or randomization of treatment in the present study.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No