Dental ImplantsNCT00136149
Study on Immediate Placement to Evaluate Astra Tech Osseospeed Implants in an Immediate Loading Protocol in Extraction Sockets and Healed Ridges
A study testing Immediate implants in people with Dental Implants, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
This is a study to evaluate immediate implants. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Implants
- What is being tested?
- Immediate implants
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2005to Dec 2013
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older
Who cannot join
- Smoking
- Medical risk patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open, Prospective, Controlled Study on Immediate Placement to Evaluate Clinical Outcome of Astra Tech Implants, Fixture Microthread Osseospeed in an Immediate Loading Protocol in Extraction Sockets and Healed Ridges
This is a study to evaluate immediate implants.
Read the detailed description
Solitary replacement of teeth by implants in upper maxilla - immediate implants
- Conditions
- Dental Implants
- Being tested
- Immediate implants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate implantsProcedure or surgery
Immediate implants are used.
| Study group | Role | What they receive |
|---|---|---|
| Immediate implants | Experimental | Not described Receives: Procedure: Immediate implants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant survival after 1 week, 3 weeks, 8 weeks, 10 weeks, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Measured: after 1 week, 3 weeks, 8 weeks, 10 weeks, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2005 (estimated)
- Study startJan 2005
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Dentsply Sirona Implants and Consumables
- Responsible party
- Sponsor
- Investigators
- Hugo De Bruyn, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00136149
- Sponsor's protocol ID
- 2004/439
- Status last verified
- Dec 2022
- First submitted
- 25 Aug 2005
- Last updated
- 20 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Prospective, Controlled Study on Immediate Placement to Evaluate Clinical Outcome of Astra Tech Implants, Fixture Microthread Osseospeed in an Immediate Loading Protocol in Extraction Sockets and Healed Ridges
- ClinicalTrials.gov ID
- NCT00136149
- Acronym / sponsor ID
- 2004/439
- Conditions
- Dental Implants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- Dentsply Sirona Implants and Consumables
- Study start
- Jan 2005 (actual)
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 26 Aug 2005 (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.
This is a study to evaluate immediate implants.
Detailed description
Solitary replacement of teeth by implants in upper maxilla - immediate implants
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Immediate implants | Experimental | Procedure: Immediate implants |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18 years of age or older
Key exclusion criteria (2 listed)
- Smoking
- Medical risk patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immediate implantsImmediate implants are used. | Procedure or surgery | Immediate implants |
Primary outcome
Implant survival after 1 week, 3 weeks, 8 weeks, 10 weeks, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Time frame: after 1 week, 3 weeks, 8 weeks, 10 weeks, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2022.
- Website University Hospital GhentLink provided by the sponsor.
Related trials for Dental Implants
Not yet recruitingPhase 1/2
Effect of Povidone Iodine on the Dental Implant Internal Surface Microbiome
Dental Implant
Recruiting
The Application of a Biphasic Calcium Sulfate Graft Material in Sinus Floor Elevation
Alveolar Bone Loss, Edentulism Nos
RecruitingObservational study
Changes in Oral Health-related Quality of Life (OHRQoL) During Full Arch Implant Treatment
Edentulous Mouth, Quality of Life
Not yet recruitingObservational study
Plaque and Bleeding on Probing Around Implants Supporting Fixed Full-Arch Dental Prostheses
Peri-Implant Health
Enrolling by invitation
Investigation of the Effect of Horizontal Platelet Rich Fibrin Placed in Tooth Extraction Sockets on Bone Formation
Tooth Loss, Dental Implant Failed
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.
Hugo De Bruyn, PhD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate implants in people with Dental Implants, run by University Hospital, Ghent at 1 site in Belgium.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 20 Dec 2022. 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 Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
Implant survival after 1 week, 3 weeks, 8 weeks, 10 weeks, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years (time frame: after 1 week, 3 weeks, 8 weeks, 10 weeks, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years). It is what the study was designed to measure, not a finding.
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 20 Dec 2022.