NCT01510470

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

January 11, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 16, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

January 16, 2012

Status Verified

January 1, 2012

Enrollment Period

1.9 years

First QC Date

January 11, 2012

Last Update Submit

January 13, 2012

Conditions

Malocclusion; Displaced or Missing Teeth

Keywords

AstraTech Osseospeed Profile ImplantMarginal bone levelsoft tissuesoft tissue responds

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with single missing maxillary or mandibular premolar or molar

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hong Kong Brånemark Osseointegration Centre

Hong Kong SAR, China

Location

MeSH Terms

Conditions

MalocclusionAnodontia

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesTooth AbnormalitiesStomatognathic System AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Hong Kong Brånemark Osseointegration Center

Study Record Dates

First Submitted

January 11, 2012

First Posted

January 16, 2012

Study Start

January 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

January 16, 2012

Record last verified: 2012-01

Locations

CN(1)