Aesthetic Evaluation of Two Piece 3mm Implants for Single Tooth Replacement of Maxillary Laterals and Mandibular Incisors

Aesthetic evaluation of two piece 3mm implants for single tooth replacement of maxillary laterals and mandibular incisors

Study Overview

• Status: Unknown
• Conditions: Recession

Detailed Description

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.

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5R 3K4
      • Dr. Suzanne Caudry PhD DDS MSc Perio Implant Dentistry and Periodontics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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.

Description

Inclusion Criteria:

• Capacity to provide written informed consent to participate in the study.
• 18 years or older

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:

• Rampant caries or unstable periodontal disease of the remaining dentition.
• Any systemic or local disease or condition that may compromise post-operative healing.
• Long-term use of systemic corticosteroids or other medications that may compromise post-operative healing.
• Present alcohol and/or drug abuse.
• Unable or unwilling to return for follow-up exams over a 3 year period.
• Pregnancy or lactation at time of enrollment.
• Smokers will be excluded from the subject pool.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	every 12 months for 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	every 12 months up to three years

Collaborators and Investigators

• Sponsor: Dr.Suzanne Caudry Implant Dentistry and Periodontics
• Investigators: Principal Investigator: Dr. Suzanne D Caudry, DDS PhD, Implant Dentistry and Periodontics

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Anticipated): March 1, 2015
• Study Completion (Anticipated): May 1, 2015

Study Registration Dates

• First Submitted: April 29, 2011
• First Submitted That Met QC Criteria: May 2, 2011
• First Posted (Estimate): May 3, 2011

Study Record Updates

• Last Update Posted (Estimate): May 3, 2011
• Last Update Submitted That Met QC Criteria: May 2, 2011
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Keywords: Recession
• Other Study ID Numbers: WIRB® Protocol #20101573