An observational study in Recession, sponsored by Dr.Suzanne Caudry Implant Dentistry and Periodontics. Status unknown at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-05-03.
Sponsored by Dr.Suzanne Caudry Implant Dentistry and Periodontics · Observational
Aesthetic evaluation of two piece 3mm implants for single tooth replacement of maxillary laterals and mandibular incisors
PURPOSE OF THE STUDY:
The purpose of this research study is to examine the aesthetics (the appearance of the implanted tooth and gums) as well as the soft tissue loss over a three-year period. This study involves replacing a missing small front tooth with a dental implant, abutment, and crown. A titanium dental implant acts as the replacement for a tooth root. An abutment is made of titanium which is either gold or silver in color and cannot be seen; but may affect the way the gum looks. An abutment is the component that attaches the crown to the implant post. A crown (which acts as the tooth replacement) is made of metal and/or porcelain and attaches over the abutment.
The dental implant and the abutments used in this study have been approved by Health Canada and the U.S. Food and Drug Administration (FDA) for the use of replacing the small teeth in the front of the mouth.
The abutment is made in two colors (either gold or silver) and you cannot choose. For each subject this is decided by chance. You will have an equal chance of getting a gold or silver-colored attachment. You will know which color the abutment will be once you have consented to be in the study and registered. You will know the color of the abutment before the implant is placed. The abutment is covered by the crown.
You will be in this study for about three years. There will be approximately 60 subjects who will participate in this study in different centres, in Canada and the USA.
This is the only study on the registry with Dr.Suzanne Caudry Implant Dentistry and Periodontics as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Subjects for this study will be recruited from the practices of the six study centers (Dr. Caudry + 5 centers from the North American PEERS group) within a period of eighteen months from commencement of the study. A total of sixty subjects (ten per center) of any gender and race aged 18 and older will be accepted provided they meet the inclusion and exclusion criteria (see page 6). Dental implants for permanent tooth replacement are not indicated for use in those under the age of 18. Vulnerable subjects will not be included.
Site requirements:
Missing one or both maxillary lateral incisors (if missing both, then both sites must be used in the study) or Single missing mandibular incisor or Two missing mandibular incisors, not adjacent to one another (both sites must be used in the study) Aside from the missing teeth specified above, all other teeth in the sextant must be present.
A minimum of premolar occlusion is required. A minimum mesio-distal and buccal-lingual distance of 5mm is required
Exclusion Criteria:
Recession
The Astra Tech 3.0 mm 2 piece implant can be placed and restored in a 5 mm or greater bone space for a mandibular incisor or maxillary lateral incisor site (minimum 5 mm mesio-distal \[side to side\] bone width and 5mm bucco-lingual \[front to back\] bone width) without exhibiting recession of the soft tissue (gingival margin or the interproximal papillae).
Time frame: every 12 months for 3 years
Esthetic parameter Scores
Esthetic parameter scores will be higher when the Atlantis Gold Hue titanium abutment is used in comparison to the Atlantis titanium abutment.
Time frame: every 12 months up to three years
This study is status unknown, as verified in Apr 2011. You cannot join it, but the record below documents what was studied.
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