Tooth InjuriesNCT01162629
Vertical Augmentation With Osteon at Dental Implant Placement
An observational study of Tooth Injuries and Tooth Abnormalities, run by Research and Education in Dentistry at 1 site in United Kingdom.
Trial summary
Dental implants are a valid and reliable method to replace missing teeth. The major requirement for their success is an adequate volume of bone into which they can be placed. One widely used method to augment bone at the time of placing the implant is to use a bone substitute rather than taking a block bone graft from… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Injuries, Tooth Abnormalities
- What is being tested?
- Osteon bone graft
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2010to Sep 2015
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Private specialist dental implant clinic
Who may be able to join
- missing one or two teeth
- bounded saddle
- healthy (ASA grade I \& II) adult
Who cannot join
- smoker
- significant medical problem (ASA III or above)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Oracle Dental Clinics
Shrewsbury, Shropshire, SY1 3GW
About this study
Official title: An Evaluation of Vertical Augmentation of Alveolar Bone With Osteon at Dental Implant Placement
Dental implants are a valid and reliable method to replace missing teeth. The major requirement for their success is an adequate volume of bone into which they can be placed. One widely used method to augment bone at the time of placing the implant is to use a bone substitute rather than taking a block bone graft from the patient. Successful augmentation in the vertical direction has often proved difficult, however, the investigators have developed a technique to achieve this in the investigators patients using a synthetic bone substitute, Osteon (Implantium, CE0120) in an attempt to avoid patients having to undergo another unnecessary surgical procedure.
Read the detailed description
Primary Objective
- To determine the success of dental implants in alveolar bone augmented in the vertical direction with Osteon.
Secondary Objectives • To determine the long term success of dental implants in this augmented bone.
Primary Endpoint
- Radiographically assessed vertical height of alveolar ridge formation following Osteon augmentation.
- Conditions
- Tooth Injuries, Tooth Abnormalities
- Being tested
- Osteon bone graft
- Keywords
- bounded saddles, missing teeth, dental implants, Tooth, Nonvital
- Medical subject headings
- Tooth Injuries, Tooth Abnormalities, Anodontia, Tooth, Nonvital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteon bone graftDevice
Also called Osteon, Hydroxyapatite coated with beta-tricalcium phosphate, 100% synthetic bone graft
Osteon bone substitute placed to a height of 2 mm above the top of the dental implant
| Study group | Role | What they receive |
|---|---|---|
| Osteon | Patients requiring dental implants with deficient alveolar bone height Receives: Device: Osteon bone graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
The success of dental implants in alveolar bone augmented in the vertical direction with Osteon
The implants will be deemed successful at each time point if the radiographic bone level remains at 2 mm above the level of the implant, i.e. at the same height as when placed. Given that we know precisely the dimensions of the abutments placed in the implant, this provides the necessary calibration in order to undertake this assessment. If the bone level is lost, the procedure will be deemed to have failed.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2010 (estimated)
- Study startSep 2010
- Primary completionSep 2015 (estimated)
- Study completionSep 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth InjuriesStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Research and Education in Dentistry
- Sponsor type
- University, hospital or other
- Investigators
- Richard J Oliver, BDS PhD, Principal investigator, Research and Education in Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01162629
- Sponsor's protocol ID
- RED001
- Status last verified
- Jul 2010
- First submitted
- 5 Jul 2010
- Last updated
- 15 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of Vertical Augmentation of Alveolar Bone With Osteon at Dental Implant Placement
- ClinicalTrials.gov ID
- NCT01162629
- Acronym / sponsor ID
- RED001
- Conditions
- Tooth Injuries, Tooth Abnormalities
- Keywords
- bounded saddles, missing teeth, dental implants, Tooth, Nonvital
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Research and Education in DentistryUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 14 Jul 2010 (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.
Dental implants are a valid and reliable method to replace missing teeth. The major requirement for their success is an adequate volume of bone into which they can be placed. One widely used method to augment bone at the time of placing the implant is to use a bone substitute rather than taking a block bone graft from the patient. Successful augmentation in the vertical direction has often proved difficult, however, the investigators have developed a technique to achieve this in the investigators patients using a synthetic bone substitute, Osteon (Implantium, CE0120) in an attempt to avoid patients having to undergo another unnecessary surgical procedure.
Detailed description
Primary Objective
- To determine the success of dental implants in alveolar bone augmented in the vertical direction with Osteon.
Secondary Objectives • To determine the long term success of dental implants in this augmented bone.
Primary Endpoint
- Radiographically assessed vertical height of alveolar ridge formation following Osteon augmentation.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Osteon | – | Device: Osteon bone graftPatients requiring dental implants with deficient alveolar bone height |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Private specialist dental implant clinic
Key inclusion criteria (3 listed)
- missing one or two teeth
- bounded saddle
- healthy (ASA grade I \& II) adult
Key exclusion criteria (2 listed)
- smoker
- significant medical problem (ASA III or above)
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 |
|---|---|---|
| Osteon bone graftAlso: Osteon, Hydroxyapatite coated with beta-tricalcium phosphate, 100% synthetic bone graftOsteon bone substitute placed to a height of 2 mm above the top of the dental implant | Device | Osteon |
Primary outcome
The success of dental implants in alveolar bone augmented in the vertical direction with Osteon
Time frame: 3 years
The implants will be deemed successful at each time point if the radiographic bone level remains at 2 mm above the level of the implant, i.e. at the same height as when placed. Given that we know precisely the dimensions of the abutments placed in the implant, this provides the necessary calibration in order to undertake this assessment. If the bone level is lost, the procedure will be deemed to have failed.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2010.
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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.
Richard J Oliver, BDS PhD principal investigator
Research and Education in Dentistry
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 Tooth Injuries and Tooth Abnormalities, run by Research and Education in Dentistry at 1 site in United Kingdom.
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 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: status not confirmed, as of the sponsor's last update on 15 Jul 2010. 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 United Kingdom. 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?
Contact Richard J Oliver, BDS PhD (00448453096323, richard.oliver@redonline.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The success of dental implants in alveolar bone augmented in the vertical direction with Osteon (time frame: 3 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 15 Jul 2010.