Aesthetic Evaluation of Two Piece 3mm Implants for Single Tooth Replacement of Maxillary Laterals and Mandibular Incisors
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Aesthetic Evaluation of Two Piece 3mm Implants for Single Tooth Replacement of Maxillary Laterals and Mandibular Incisors|
- Recession [ Time Frame: every 12 months for 3 years ] [ Designated as safety issue: No ]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).
- Esthetic parameter Scores [ Time Frame: every 12 months up to three years ] [ Designated as safety issue: No ]Esthetic parameter scores will be higher when the Atlantis Gold Hue titanium abutment is used in comparison to the Atlantis titanium abutment.
|Study Start Date:||May 2011|
|Estimated Study Completion Date:||May 2015|
|Estimated Primary Completion Date:||March 2015 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01346345
|Dr. Suzanne Caudry PhD DDS MSc Perio Implant Dentistry and Periodontics|
|Toronto, Ontario, Canada, M5R 3K4|
|Principal Investigator:||Dr. Suzanne D Caudry, DDS PhD||Implant Dentistry and Periodontics|