Malocclusion; Displaced or Missing TeethNCT01510470
Clinical and Radiological Outcomes Study on Astra Tech Osseospeed Tx Profile Implant
An observational study of Malocclusion; Displaced or Missing Teeth, run by Hong Kong Brånemark Osseointegration Center at 1 site in China.
Trial summary
The Astra Tech Osseospeed Profile Implant design when placed in the healed extraction site maintains the marginal bone level Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Malocclusion; Displaced or Missing Teeth
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- Jan 2012to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with single missing maxillary or mandibular premolar or molar
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
The Astra Tech Osseospeed Profile Implant design when placed in the healed extraction site maintains the marginal bone level
- Conditions
- Malocclusion; Displaced or Missing Teeth
- Keywords
- AstraTech Osseospeed Profile Implant, Marginal bone level, soft tissue, soft tissue responds
- Medical subject headings
- Malocclusion, Anodontia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malocclusion; Displaced or Missing TeethStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hong Kong Brånemark Osseointegration Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dentsply Sirona Implants and Consumables
- Responsible party
- Principal investigator, Dr. Philip Lee KM, Hong Kong Brånemark Osseointegration Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01510470
- Sponsor's protocol ID
- D2011028
- Status last verified
- Jan 2012
- First submitted
- 11 Jan 2012
- Last updated
- 16 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiological Outcomes Study on Astra Tech Osseospeed Tx Profile Implant
- ClinicalTrials.gov ID
- NCT01510470
- Acronym / sponsor ID
- D2011028
- Conditions
- Malocclusion; Displaced or Missing Teeth
- Keywords
- AstraTech Osseospeed Profile Implant, Marginal bone level, soft tissue, soft tissue responds
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Hong Kong Brånemark Osseointegration CenterUniversity, hospital or other
- Collaborators
- Dentsply Sirona Implants and Consumables
- Study start
- Jan 2012
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 16 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Astra Tech Osseospeed Profile Implant design when placed in the healed extraction site maintains the marginal bone level
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with single missing maxillary or mandibular premolar or molar
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2012.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malocclusion; Displaced or Missing Teeth, run by Hong Kong Brånemark Osseointegration Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2012.