EdentulismPhase 4NCT00780273
Success Rate of Immediately Loaded Implants With Platform Switched Design Placed in Anterior Part of Mandible and Restored With Fixed Prostheses
A Phase 4 study testing Ankylos Implants and Biomet 3i Prevail Implants in people with Edentulism, run by Dentsply International at 1 site in United States.
Trial summary
Change in crestal bone level implants at 5% significance level. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Edentulism
- What is being tested?
- Ankylos Implants and Biomet 3i Prevail Implants
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Apr 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18 to 80
- male or female (female non-pregnant)
- sufficient oral hygiene
- no inflammation/disorder in the area of implant site
- edentulous mandible and sufficient prosthetic and conservative
- sufficient width and height of bone to place implants with diameters of 4.8mm and length of 11 mm
- provide written informed consent
Who cannot join
- demonstrate a need for pre-surgical bone or soft tissue augmentation in planned implant areas
- exhibit angulation requirements of restoration exceeding 15 degrees
- systemic metabolic disorder that would compromise post-operative tissue regeneration or osseointegration
- taking medication that would compromise post-operative healing and/or osseointegration
- bone disorders such as osteoporosis, hyperparathyroidism, Paget's disease, diabetes mellitus
- oncology treatment
Show all 18Show fewer
- oral infection
- acute gingivitis and/or periodontitis
- local bone defects in the area of planned implantation
- disorders of oral mucosa (e.g., leukoplakia, oral lichen, pemphigoid lesions)
- received investigational drug within 30 days
- history of illicit drugs or alcohol abuse
- history of addiction to medication
- allergic to dental materials
- nicotine abuse (> 20 cigarettes/day)
- pregnant or nursing
- clinical significant or unstable medical or physiological conditions that would compromise participation in study
- unable or unwilling to return for follow-up visits for a period of 24 months
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester, Eastman Dept of Dentistry
Rochester, New York, 14620
About this study
Official title: Success Rate of Immediately Loaded Implants With Platform Switched Design Placed in the Anterior Part of the Mandible and Restored With Fixed Prostheses: a Randomized, Split-mouth, Masked, Prospective, Open, Comparison, Monocenter Trial
Change in crestal bone level implants at 5% significance level.
- Conditions
- Edentulism
- Being tested
- Ankylos Implants, Biomet 3i Prevail Implants
- Keywords
- subjects with edentulous mandible
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ankylos ImplantsDevice
ANKYLOS Implant System vs Certain PREVAIL Implant
Biomet 3i Prevail ImplantsDevice
| Study group | Role | What they receive |
|---|---|---|
| Ankylos dental implants. | Experimental | 3 Ankylos dental implants placed in platform switch configuration on one side of the mandible in support of a fixed restoration.
A total number of 19 subjects participated in this randomized, split mouth, masked, prospective, open, comparison, monocenter study. Participants were subjects with an edentulous mandible who recieved 3 implants on each side which were splinted for the delivery of a fixed prosthesis. Receives: Device: Ankylos Implants |
| 3i Prevail dental implants. | Active comparator | Three 3i Prevail dental implants placed on the opposite side of the mandible from the Ankylos implants in support of fixed dental restoration.
After a baseline phase of 1 month the mandible sides of subjects were randomly assigned to one of the 2 parallel treatment groups: one side received ANKYLOS plus implants. The contralateral sde recieved Certain PREVAIL Implants. Abutments were installed and loaded immediately by a fixed temporary bridge. After 3 months the final prosthesis was incorporated. Receives: Device: Biomet 3i Prevail Implants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness - Treatment Difference in Mean Change in Crestal Bone Level
Incidence of greater than 2 mm crestal bone (mesial or distal) loss. Reported in the percentage of analyzed implants.
Measured: 6 months after surgery
Effectiveness - Treatment Difference in Mean Change in Crestal Bone Level
Incidence of greater than 2 mm crestal bone (mesial or distal) loss. Reported in the percentage of analyzed implants.
Measured: 12 months after surgery
Effectiveness - Treatment Difference in Mean Change in Crestal Bone Level
Incidence of greater than 2 mm crestal bone (mesial or distal) loss. Reported in the percentage of analyzed implants.
Measured: 24 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2008 (estimated)
- Study startSep 2008
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for EdentulismStudies 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 4
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dentsply International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- George Romanos, DDS, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00780273
- Sponsor's protocol ID
- DF 245
- Status last verified
- Aug 2014
- First submitted
- 24 Oct 2008
- Last updated
- 19 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Success Rate of Immediately Loaded Implants With Platform Switched Design Placed in the Anterior Part of the Mandible and Restored With Fixed Prostheses: a Randomized, Split-mouth, Masked, Prospective, Open, Comparison, Monocenter Trial
- ClinicalTrials.gov ID
- NCT00780273
- Acronym / sponsor ID
- DF 245
- Conditions
- Edentulism
- Keywords
- subjects with edentulous mandible
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Dentsply InternationalIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 27 Oct 2008 (estimated)
- Results
- Posted 19 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Change in crestal bone level implants at 5% significance level.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ankylos dental implants. | Experimental | Device: Ankylos Implants3 Ankylos dental implants placed in platform switch configuration on one side of the mandible in support of a fixed restoration. A total number of 19 subjects participated in this randomized, split mouth, masked, prospective, open, comparison, monocenter study. Participants were subjects with an edentulous mandible who recieved 3 implants on each side which were splinted for the delivery of a fixed prosthesis. |
| 3i Prevail dental implants. | Active comparator | Device: Biomet 3i Prevail ImplantsThree 3i Prevail dental implants placed on the opposite side of the mandible from the Ankylos implants in support of fixed dental restoration. After a baseline phase of 1 month the mandible sides of subjects were randomly assigned to one of the 2 parallel treatment groups: one side received ANKYLOS plus implants. The contralateral sde recieved Certain PREVAIL Implants. Abutments were installed and loaded immediately by a fixed temporary bridge. After 3 months the final prosthesis was incorporated. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- age 18 to 80
- male or female (female non-pregnant)
- sufficient oral hygiene
- no inflammation/disorder in the area of implant site
- edentulous mandible and sufficient prosthetic and conservative
Key exclusion criteria (18 listed)
- demonstrate a need for pre-surgical bone or soft tissue augmentation in planned implant areas
- exhibit angulation requirements of restoration exceeding 15 degrees
- systemic metabolic disorder that would compromise post-operative tissue regeneration or osseointegration
- taking medication that would compromise post-operative healing and/or osseointegration
- bone disorders such as osteoporosis, hyperparathyroidism, Paget's disease, diabetes mellitus
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 |
|---|---|---|
| Ankylos ImplantsANKYLOS Implant System vs Certain PREVAIL Implant | Device | Ankylos dental implants. |
| Biomet 3i Prevail Implants | Device | 3i Prevail dental implants. |
Primary outcome
Effectiveness - Treatment Difference in Mean Change in Crestal Bone Level
Time frame: 6 months after surgery
Incidence of greater than 2 mm crestal bone (mesial or distal) loss. Reported in the percentage of analyzed implants.
Effectiveness - Treatment Difference in Mean Change in Crestal Bone Level
Time frame: 12 months after surgery
Incidence of greater than 2 mm crestal bone (mesial or distal) loss. Reported in the percentage of analyzed implants.
Effectiveness - Treatment Difference in Mean Change in Crestal Bone Level
Time frame: 24 months after surgery
Incidence of greater than 2 mm crestal bone (mesial or distal) loss. Reported in the percentage of analyzed implants.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
George Romanos, DDS principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ankylos Implants and Biomet 3i Prevail Implants in people with Edentulism, run by Dentsply International at 1 site in United States.
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 7 inclusion and 18 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 19 Aug 2014. 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 States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Effectiveness - Treatment Difference in Mean Change in Crestal Bone Level (time frame: 6 months after surgery). The study lists 3 primary outcomes in all. 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 19 Aug 2014.