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



Status:Active, not recruiting
Conditions:Dental
Therapuetic Areas:Dental / Maxillofacial Surgery
Healthy:No
Age Range:18 - Any
Updated:9/9/2017
Start Date:February 2009

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Prospective, Comparative Assessment of Single-tooth Replacement in Different Implant-abutment Settings

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.


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.
We found this trial at
4
sites
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Iowa City, IA
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Chapel Hill, North Carolina 27599
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Chapel Hill, NC
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Houston, TX
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Montreal,
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