Partial EdentulismPegasusNCT01529736
Randomized Study of Integration Success of Osseotite Dental Implants Placed Using Different Insertion Procedures
A study testing High torque insertion and Low torque insertion in people with Partial Edentulism and Tooth Disease, run by ZimVie at 1 site in Colombia.
Trial summary
Osseotite implants placed with higher insertion torque (TEST procedure) will have higher initial stability and integration success than those placed with lower insertion torque forces. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Partial Edentulism, Tooth Disease
- What is being tested?
- High torque insertion and Low torque insertion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteColombia
- Study dates
- Dec 2010to Dec 2016
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients of either sex and older than 18 years of age
- patients needing a minimum of 3 implants to treat partial edentulism
- patients physically able to tolerate surgical and restorative dental procedures
- patients agreeing to all protocol visits
Who cannot join
- patients with infection or severe inflammation at the intended treatment sites
- patients smoking greater than 10 cigarettes per day
- patients with uncontrolled diabetes mellitus
- patients with uncontrolled metabolic diseases
- patients who received radiation treatment to the head in the past 12 months
- patients needing bone grafting at the intended treatment sites
- patients known to be pregnant at screening visit
- patients with para-functional habits like bruxing and clenching
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomized-controlled Study of the Integration Success of Osseotite Implants Placed With Different Insertion Procedures
Osseotite implants placed with higher insertion torque (TEST procedure) will have higher initial stability and integration success than those placed with lower insertion torque forces.
Read the detailed description
Osseotite implants will be placed using the standard lower insertion torque forces and compared to implants placed using higher insertion torque forces.
- Conditions
- Partial Edentulism, Tooth Disease
- Being tested
- High torque insertion, Low torque insertion
- Keywords
- edentulism, dental implants, early loading, crestal bone level, high torque insertion, low torque insertion, randomized, Osseotite, clinical study
- Medical subject headings
- Tooth Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High torque insertionProcedure or surgery
Also called Osseotite endosseous dental implant
Osseotite implant placed with high insertion torque forces
Low torque insertionProcedure or surgery
Also called Osseotite endosseous dental implant
Osseotite implant placed with low insertion torque forces
| Study group | Role | What they receive |
|---|---|---|
| High torque insertion | Experimental | High torque insertion Receives: Procedure: High torque insertion |
| Low torque insertion | Active comparator | Low torque insertion Receives: Procedure: Low torque insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
primary stability countertorque measures
resistance to countertorque measures showing primary stability success of implants
Measured: 4 months
Secondary outcomes (1)
cumulative success rate
Crestal bone regression (amount of bone loss measured) and equivalence in integration success (implant mobility)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2012 (estimated)
- Study startDec 2010
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Partial 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- ZimVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Armando Estefan, DMD, Principal investigator, Universidad Javeriana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01529736
- Sponsor's protocol ID
- 3004
- Acronym
- Pegasus
- Status last verified
- Mar 2022
- First submitted
- 7 Feb 2012
- Last updated
- 28 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized-controlled Study of the Integration Success of Osseotite Implants Placed With Different Insertion Procedures
- ClinicalTrials.gov ID
- NCT01529736
- Acronym / sponsor ID
- Pegasus / 3004
- Conditions
- Partial Edentulism, Tooth Disease
- Keywords
- edentulism, dental implants, early loading, crestal bone level, high torque insertion, low torque insertion, randomized, Osseotite
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- ZimVieIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 9 Feb 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.
Osseotite implants placed with higher insertion torque (TEST procedure) will have higher initial stability and integration success than those placed with lower insertion torque forces.
Detailed description
Osseotite implants will be placed using the standard lower insertion torque forces and compared to implants placed using higher insertion torque forces.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High torque insertion | Experimental | Procedure: High torque insertionHigh torque insertion |
| Low torque insertion | Active comparator | Procedure: Low torque insertionLow torque insertion |
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 older than 18 years of age
- patients needing a minimum of 3 implants to treat partial edentulism
- patients physically able to tolerate surgical and restorative dental procedures
- patients agreeing to all protocol visits
Key exclusion criteria (8 listed)
- patients with infection or severe inflammation at the intended treatment sites
- patients smoking greater than 10 cigarettes per day
- patients with uncontrolled diabetes mellitus
- patients with uncontrolled metabolic diseases
- patients who received radiation treatment to the head in the past 12 months
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 |
|---|---|---|
| High torque insertionAlso: Osseotite endosseous dental implantOsseotite implant placed with high insertion torque forces | Procedure or surgery | High torque insertion |
| Low torque insertionAlso: Osseotite endosseous dental implantOsseotite implant placed with low insertion torque forces | Procedure or surgery | Low torque insertion |
Primary outcome
primary stability countertorque measures
Time frame: 4 months
resistance to countertorque measures showing primary stability success of implants
1 secondary outcome
cumulative success rate
Time frame: 1 year
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 28 Mar 2022.
- Individual participant dataSharing planned: Undecided
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Clinical Fit of Conventionally Cast and 0° SLM Removable Partial Denture Frameworks
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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.
Armando Estefan, DMD principal investigator
Universidad Javeriana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High torque insertion and Low torque insertion in people with Partial Edentulism and Tooth Disease, run by ZimVie 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: finished, as of the sponsor's last update on 28 Mar 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 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.
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?
primary stability countertorque measures (time frame: 4 months). 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 28 Mar 2022.