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

Malocclusion; Displaced or Missing Teeth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01510470
• Other study ID #: D2011028
• Status: Enrolling by invitation
• Phase: N/A
• First received: January 11, 2012
• Last updated: January 13, 2012
• Start date: January 2012
• Est. completion date: December 2013

Study information

• Verified date: January 2012
• Source: Hong Kong Brånemark Osseointegration Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Hong Kong Dental Council
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 15
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anodontia
• Malocclusion
• Malocclusion; Displaced or Missing Teeth
• Tooth Loss

Locations

Country	Name	City	State
China	Hong Kong Brånemark Osseointegration Centre	Hong Kong SAR

Sponsors (2)

Lead Sponsor	Collaborator
Hong Kong Brånemark Osseointegration Center	Dentsply Implants

Country where clinical trial is conducted

China,