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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
History of Changes
  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

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
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 June 18, 2013