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

NCT01346345 | Unknown DMC

• 1 other identifier: WIRB® Protocol #20101573
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Recession

Keywords

Recession

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Esthetic parameter Scores

  every 12 months up to three years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Capacity to provide written informed consent to participate in the study.
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr.Suzanne Caudry Implant Dentistry and Periodontics: lead

Study Sites (1)

Dr. Suzanne Caudry PhD DDS MSc Perio Implant Dentistry and Periodontics

Toronto, Ontario, M5R 3K4, Canada

Location

Study Officials

• Dr. Suzanne D Caudry, DDS PhD

  Implant Dentistry and Periodontics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 29, 2011
• First Posted: May 3, 2011
• Study Start: May 1, 2011
• Primary Completion: March 1, 2015
• Study Completion: May 1, 2015
• Last Updated: May 3, 2011

Record last verified: 2011-04

Locations

CA (1)