Back to resultsRandomized Study of Integration Success of Osseotite Dental Implants Placed Using Different Insertion Procedures (Pegasus)
Primary Purpose
Partial Edentulism, Tooth Disease
Status
Completed
Phase
Not Applicable
Locations
Colombia
Study Type
Interventional
Intervention
High torque insertion
Low torque insertion
Sponsored by
About this trial
This is an interventional treatment trial for Partial Edentulism focused on measuring edentulism, dental implants, early loading, crestal bone level, high torque insertion, low torque insertion, randomized, Osseotite, clinical study
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Universidad Javeriana
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
High torque insertion
Low torque insertion
Arm Description
High torque insertion
Low torque insertion
Outcomes
Primary Outcome Measures
primary stability countertorque measures
resistance to countertorque measures showing primary stability success of implants
Secondary Outcome Measures
cumulative success rate
Crestal bone regression (amount of bone loss measured) and equivalence in integration success (implant mobility)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01529736
Brief Title
Randomized Study of Integration Success of Osseotite Dental Implants Placed Using Different Insertion Procedures
Acronym
Pegasus
Official Title
Prospective Randomized-controlled Study of the Integration Success of Osseotite Implants Placed With Different Insertion Procedures
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ZimVie
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed Description
Osseotite implants will be placed using the standard lower insertion torque forces and compared to implants placed using higher insertion torque forces.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Partial Edentulism, Tooth Disease
Keywords
edentulism, dental implants, early loading, crestal bone level, high torque insertion, low torque insertion, randomized, Osseotite, clinical study
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High torque insertion
Arm Type
Experimental
Arm Description
High torque insertion
Arm Title
Low torque insertion
Arm Type
Active Comparator
Arm Description
Low torque insertion
Intervention Type
Procedure
Intervention Name(s)
High torque insertion
Other Intervention Name(s)
Osseotite endosseous dental implant
Intervention Description
Osseotite implant placed with high insertion torque forces
Intervention Type
Procedure
Intervention Name(s)
Low torque insertion
Other Intervention Name(s)
Osseotite endosseous dental implant
Intervention Description
Osseotite implant placed with low insertion torque forces
Primary Outcome Measure Information:
Title
primary stability countertorque measures
Description
resistance to countertorque measures showing primary stability success of implants
Time Frame
4 months
Secondary Outcome Measure Information:
Title
cumulative success rate
Description
Crestal bone regression (amount of bone loss measured) and equivalence in integration success (implant mobility)
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Armando Estefan, DMD
Organizational Affiliation
Universidad Javeriana
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad Javeriana
City
Bogota
Country
Colombia
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Randomized Study of Integration Success of Osseotite Dental Implants Placed Using Different Insertion Procedures
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