Clinical and Radiological Outcomes Study on Astra Tech Osseospeed Tx Profile Implant

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Dentsply Implants
Information provided by (Responsible Party):
Dr. Philip Lee KM, Hong Kong Brånemark Osseointegration Center
ClinicalTrials.gov Identifier:
NCT01510470
First received: January 11, 2012
Last updated: January 13, 2012
Last verified: January 2012
  Purpose

The Astra Tech Osseospeed Profile Implant design when placed in the healed extraction site maintains the marginal bone level


Condition
Malocclusion; Displaced or Missing Teeth

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Clinical and Radiological Outcomes Study on Astra Tech Osseospeed Tx Profile Implant

Resource links provided by NLM:


Further study details as provided by Hong Kong Brånemark Osseointegration Center:

Estimated Enrollment: 15
Study Start Date: January 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients with single missing maxillary or mandibular premolar or molar

Criteria

Inclusion Criteria:

  • Patients with single missing maxillary or mandibular premolar or molar
  • The edentulous sites should be healed sites
  • The opposing tooth will be a natural dentition

Exclusion Criteria:

  • general contraindications to dental implant surgery
  • Patient with irradiation in the head and neck region
  • Immuno-suppressed or immuno-compromised patients
  • Patients who took or are taking amino-bisphosphonates
  • Patients with poor oral hygiene and motivation
  • Patients with untreated periodontitis
  • Uncontrolled diabetes
  • Pregnancy or lactation
  • Addiction to alcohol or other drugs
  • patients with psychiatric problems
  • Lack of occluding dentition/prosthesis
  • Restricted mouth opening (less than 3.5cm inter-arch anteriorly)
  • Patients with an acute or chronic infection/inflammation in the area intended for implant placement
  • Patients unable to commit 5 years follow up
  • Patients referred for implant placement only
  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: NCT01510470

Locations
China
Hong Kong Brånemark Osseointegration Centre
Hong Kong SAR, China
Sponsors and Collaborators
Hong Kong Brånemark Osseointegration Center
Dentsply Implants
  More Information

No publications provided

Responsible Party: Dr. Philip Lee KM, Director, Hong Kong Brånemark Osseointegration Center, Hong Kong Brånemark Osseointegration Center
ClinicalTrials.gov Identifier: NCT01510470     History of Changes
Other Study ID Numbers: D2011028
Study First Received: January 11, 2012
Last Updated: January 13, 2012
Health Authority: Hong Kong: Hong Kong Dental Council

Keywords provided by Hong Kong Brånemark Osseointegration Center:
AstraTech Osseospeed Profile Implant
Marginal bone level
soft tissue
soft tissue responds

Additional relevant MeSH terms:
Malocclusion
Tooth Loss
Anodontia
Tooth Diseases
Stomatognathic Diseases
Periodontal Diseases
Mouth Diseases
Tooth Abnormalities
Stomatognathic System Abnormalities
Congenital Abnormalities

ClinicalTrials.gov processed this record on August 28, 2014