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

Recession Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01346345
• Other study ID #: WIRB® Protocol #20101573
• Status: Enrolling by invitation
• Phase: N/A
• First received: April 29, 2011
• Last updated: May 2, 2011
• Start date: May 2011
• Est. completion date: May 2015

Study information

• Verified date: April 2011
• Source: Dr.Suzanne Caudry Implant Dentistry and Periodontics
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review CommitteeCanada: Health CanadaUnited States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: May 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Recession

Locations

Country	Name	City	State
Canada	Dr. Suzanne Caudry PhD DDS MSc Perio Implant Dentistry and Periodontics	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Dr.Suzanne Caudry Implant Dentistry and Periodontics

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No