Jaw, Edentulous, PartiallyPhase 3OCPTINCT01611493
Osseotite Certain Prevail for the Preservation of Crestal Bone
A Phase 3 study testing Osseotite Prevail Implant and Osseotite Non Prevail Implant in people with Jaw, Edentulous, Partially, run by Andres Duque Duque at 1 site in Colombia.
Trial summary
A potential complicating factor affecting implants is crestal bone loss. The causes of crestal bone loss are attributed to several factors. Among those hypothesized, proof for one or another cause remains obscure. Clinical documentation suggests that implant design may be a key factor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Jaw, Edentulous, Partially
- What is being tested?
- Osseotite Prevail Implant and Osseotite Non Prevail Implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteColombia
- Study dates
- Mar 2011to Sep 2013
- Phase
- Phase 3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of either sex and any race greater than 18 years of age
- Patients for whom a decision has already been made to use dental implants for the restoration of existing edentulism in the mandible or maxilla.
- Patients must be physically able to tolerate conventional surgical and restorative procedures.
- Patients must agree to be evaluated for each study visit, especially the yearly follow-up visits.
Who cannot join
- Patients with active infection or severe inflammation in the areas intended for implant placement.
- Patients with a > 10 cigarette per day smoking habit.
- Patients with uncontrolled diabetes mellitus.
- Patients with uncontrolled metabolic bone disease where there is a diagnosis of the following: Osteomalacia, primary or secondary hyperparathyroidism, renal osteodystrophy, or Paget's disease of bone.
- Patients with a history of therapeutic radiation to the head
- Patients in need of bone grafting at the site of the intended study implant for augmentation purposes.
- Patients who are known to be pregnant at the screening visit.
- Patients with evidence of severe para-functional habits such as bruxing or clenching
Trial locations and contacts
1 site in 1 country.
Colombia1 site, 1 recruiting
- Recruiting
CES University / Faculty of Dentistry
Medellín, Antioquia, 050021
Andres Duque, MSc, (0574)4440555 ext. 1515, aduqued@ces.edu.co
Andres Duque, MSc
About this study
Official title: A Prospective, Randomized-Controlled Evaluation of the Osseotite CP4 Certain Prevail Tapered Implant for the Preservation of Crestal Bone
A potential complicating factor affecting implants is crestal bone loss. The causes of crestal bone loss are attributed to several factors. Among those hypothesized, proof for one or another cause remains obscure. Clinical documentation suggests that implant design may be a key factor. While the evidence is inconclusive, various authors suggest that it is a result of a combination of effects including (1) limited drilling procedure and restricted second-stage surgery 2, (2) rough implant surface in crestal bone 3, (3) microthread design for implant stiffness 4, (4) loading along a conus versus a flat interface 5, and (5) the absence of a significant microgap 6.
The practice of platform switching (e.g. placing a 4 mm diameter abutment on a 5 mm implant seating surface physically moves the inflammatory cell infiltrate zone away from the crestal bone). The growing body of anecdotal platform switch evidence supports this biological width hypothesis. Here the biological width refers to the height of the dento-gingival attachment apparatus around a normal tooth and is defined as the distance necessary for a healthy existence of bone and soft tissue from the most apical extent of a dental restoration.
To formally test this hypothesis the current study has been designed. The Prevail implant has been made with an integrated medialized seating surface that establishes a platform switching function. This implant moves the implant/abutment interface away from the crestal bone and may therefore reduce the amount of bone loss observed in the standard (non-medialized) Osseotite implant design. The objective of this study is to evaluate crestal bone levels adjacent to the implant reference point from the time of implant placement to a period of two years after loading.
- Conditions
- Jaw, Edentulous, Partially
- Being tested
- Osseotite Prevail Implant, Osseotite Non Prevail Implant
- Keywords
- Dental Implants, Jaw, Edentulous, Partially/rehabilitation, Jaw, Edentulous, Partially/surgery, randomised Clinical Trials, Humans
- Medical subject headings
- Jaw, Edentulous, Partially, Mouth, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osseotite Prevail ImplantDevice
Osseotite Prevail will be placed in sites with native bone, with at least three months of healing since tooth extraction or four months from bone augmentation grafting procedure
Osseotite Non Prevail ImplantDevice
Osseotite Non Prevail Implant will be placed in sites with native bone, with at least three months of healing since tooth extraction or four months from bone augmentation grafting procedure
| Study group | Role | What they receive |
|---|---|---|
| Osseotite Prevail Implant | Experimental | The Osseotite Prevail will be placed in sites with native bone, with at least three months of healing since tooth extraction or four months from bone augmentation grafting procedure. Receives: Device: Osseotite Prevail Implant |
| Osseotite Non Prevail Implant | Active comparator | Osseotite Non Prevail Implant will be placed in sites with native bone, with at least three months of healing since tooth extraction or four months from bone augmentation grafting procedure Receives: Device: Osseotite Non Prevail Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preservation of crestal bone
Measured: Two years
Secondary outcomes (1)
Osseus integration
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2012 (estimated)
- Study startMar 2011
- Primary completionNov 2012 (estimated)
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Jaw, Edentulous, PartiallyStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Andres Duque Duque
- Sponsor type
- University, hospital or other
- Collaborators
- Zimmer Biomet
- Responsible party
- Sponsor-investigator, Andres Duque Duque, CES University
- Investigators
- Andres Duque, MSc, Principal investigator, CES UniversityPablo E Correa, MSc, Principal investigator, CES UniversityAstrid Giraldo, Postgraduate, Principal investigator, CES University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01611493
- Sponsor's protocol ID
- implantes3i
- Acronym
- OCPTI
- Status last verified
- Jun 2012
- First submitted
- 31 May 2012
- Last updated
- 5 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized-Controlled Evaluation of the Osseotite CP4 Certain Prevail Tapered Implant for the Preservation of Crestal Bone
- ClinicalTrials.gov ID
- NCT01611493
- Acronym / sponsor ID
- OCPTI / implantes3i
- Conditions
- Jaw, Edentulous, Partially
- Keywords
- Dental Implants, Jaw, Edentulous, Partially/rehabilitation, Jaw, Edentulous, Partially/surgery, randomised Clinical Trials, Humans
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Andres Duque DuqueUniversity, hospital or other
- Collaborators
- Zimmer Biomet
- Study start
- Mar 2011
- Primary completion
- Nov 2012 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 5 Jun 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.
A potential complicating factor affecting implants is crestal bone loss. The causes of crestal bone loss are attributed to several factors. Among those hypothesized, proof for one or another cause remains obscure. Clinical documentation suggests that implant design may be a key factor. While the evidence is inconclusive, various authors suggest that it is a result of a combination of effects including (1) limited drilling procedure and restricted second-stage surgery 2, (2) rough implant surface in crestal bone 3, (3) microthread design for implant stiffness 4, (4) loading along a conus versus a flat interface 5, and (5) the absence of a significant microgap 6.
The practice of platform switching (e.g. placing a 4 mm diameter abutment on a 5 mm implant seating surface physically moves the inflammatory cell infiltrate zone away from the crestal bone). The growing body of anecdotal platform switch evidence supports this biological width hypothesis. Here the biological width refers to the height of the dento-gingival attachment apparatus around a normal tooth and is defined as the distance necessary for a healthy existence of bone and soft tissue from the most apical extent of a dental restoration.
To formally test this hypothesis the current study has been designed. The Prevail implant has been made with an integrated medialized seating surface that establishes a platform switching function. This implant moves the implant/abutment interface away from the crestal bone and may therefore reduce the amount of bone loss observed in the standard (non-medialized) Osseotite implant design. The objective of this study is to evaluate crestal bone levels adjacent to the implant reference point from the time of implant placement to a period of two years after loading.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Osseotite Prevail Implant | Experimental | Device: Osseotite Prevail ImplantThe Osseotite Prevail will be placed in sites with native bone, with at least three months of healing since tooth extraction or four months from bone augmentation grafting procedure. |
| Osseotite Non Prevail Implant | Active comparator | Device: Osseotite Non Prevail ImplantOsseotite Non Prevail Implant will be placed in sites with native bone, with at least three months of healing since tooth extraction or four months from bone augmentation grafting procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients of either sex and any race greater than 18 years of age
- Patients for whom a decision has already been made to use dental implants for the restoration of existing edentulism in the mandible or maxilla.
- Patients must be physically able to tolerate conventional surgical and restorative procedures.
- Patients must agree to be evaluated for each study visit, especially the yearly follow-up visits.
Key exclusion criteria (8 listed)
- Patients with active infection or severe inflammation in the areas intended for implant placement.
- Patients with a > 10 cigarette per day smoking habit.
- Patients with uncontrolled diabetes mellitus.
- Patients with uncontrolled metabolic bone disease where there is a diagnosis of the following: Osteomalacia, primary or secondary hyperparathyroidism, renal osteodystrophy, or Paget's disease of bone.
- Patients with a history of therapeutic radiation to the head
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 |
|---|---|---|
| Osseotite Prevail ImplantOsseotite Prevail will be placed in sites with native bone, with at least three months of healing since tooth extraction or four months from bone augmentation grafting procedure | Device | Osseotite Prevail Implant |
| Osseotite Non Prevail ImplantOsseotite Non Prevail Implant will be placed in sites with native bone, with at least three months of healing since tooth extraction or four months from bone augmentation grafting procedure | Device | Osseotite Non Prevail Implant |
Primary outcome
Preservation of crestal bone
Time frame: Two years
1 secondary outcome
Osseus integration
Time frame: Two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2012.
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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.
Andres Duque, MSc principal investigator
CES University
Pablo E Correa, MSc principal investigator
CES University
Astrid Giraldo, Postgraduate principal investigator
CES University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Osseotite Prevail Implant and Osseotite Non Prevail Implant in people with Jaw, Edentulous, Partially, run by Andres Duque Duque at 1 site in Colombia.
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 4 inclusion and 8 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 5 Jun 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 Colombia. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Andres Duque, MSc ((0574)444055 ext. 1515, aduqued@ces.edu.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preservation of crestal bone (time frame: Two 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 5 Jun 2012.