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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Dr.Suzanne Caudry Implant Dentistry and Periodontics
ClinicalTrials.gov Identifier:
NCT01346345
First received: April 29, 2011
Last updated: May 2, 2011
Last verified: April 2011
  Purpose

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


Condition
Recession

Study Type: Observational
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

Further study details as provided by Dr.Suzanne Caudry Implant Dentistry and Periodontics:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 60
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)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01346345

Locations
Canada, Ontario
Dr. Suzanne Caudry PhD DDS MSc Perio Implant Dentistry and Periodontics
Toronto, Ontario, Canada, M5R 3K4
Sponsors and Collaborators
Dr.Suzanne Caudry Implant Dentistry and Periodontics
Investigators
Principal Investigator: Dr. Suzanne D Caudry, DDS PhD Implant Dentistry and Periodontics
  More Information

No publications provided

Responsible Party: Suzanne Caudry, PhD, DDS, MSc, Dr. Suzanne Caudry Implant Dentistry and Periodontics
ClinicalTrials.gov Identifier: NCT01346345     History of Changes
Other Study ID Numbers: WIRB® Protocol #20101573
Study First Received: April 29, 2011
Last Updated: May 2, 2011
Health Authority: Canada: Ethics Review Committee
Canada: Health Canada
United States: Food and Drug Administration

Keywords provided by Dr.Suzanne Caudry Implant Dentistry and Periodontics:
Recession

ClinicalTrials.gov processed this record on September 14, 2014