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

Sponsor
Hong Kong Brånemark Osseointegration Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT01510470
Collaborator
Dentsply Sirona Implants (Industry)
15
Enrollment
1
Location
23
Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    15 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Clinical and Radiological Outcomes Study on Astra Tech Osseospeed Tx Profile Implant
    Study Start Date :
    Jan 1, 2012
    Anticipated Primary Completion Date :
    Dec 1, 2013
    Anticipated Study Completion Date :
    Dec 1, 2013

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      20 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      Yes
      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

      Locations

      Site City State Country Postal Code
      1 Hong Kong Brånemark Osseointegration Centre Hong Kong SAR China

      Sponsors and Collaborators

      • Hong Kong Brånemark Osseointegration Center
      • Dentsply Sirona Implants

      Investigators

      None specified.

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      Dr. Philip Lee KM, Director, Hong Kong Brånemark Osseointegration Center, Hong Kong Brånemark Osseointegration Center
      ClinicalTrials.gov Identifier:
      NCT01510470
      Other Study ID Numbers:
      • D2011028
      First Posted:
      Jan 16, 2012
      Last Update Posted:
      Jan 16, 2012
      Last Verified:
      Jan 1, 2012
      Keywords provided by Dr. Philip Lee KM, Director, Hong Kong Brånemark Osseointegration Center, 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

      Study Results

      No Results Posted as of Jan 16, 2012