Randomized Study of Integration Success of Osseotite Dental Implants Placed Using Different Insertion Procedures

NCT01529736 — Not applicable, Completed, 60 participants, ZimVie
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Prospective Randomized-controlled Study of the Integration Success of Osseotite Implants Placed With Different Insertion Procedures

RegistryNCT01529736, acronym Pegasus
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: single, treatment
Enrollment60 (Actual)
SponsorZimVie (Industry)
ConditionsPartial Edentulism, Tooth Disease
InterventionsHigh torque insertion, Low torque insertion (Procedure)
Datesstart 2010-12-01, primary completion 2016-12-01, completion 2016-12-01, first posted 2012-02-09, last updated 2022-03-28
Locations1 site in Colombia

Related Papers Related Patents Related Grants Related Experts
All trials for Partial Edentulism All trials for Tooth Disease All trials of High torque insertion All trials of Low torque insertion

-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.

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+Detailed description

Osseotite implants will be placed using the standard lower insertion torque forces and compared to implants placed using higher insertion torque forces.

+Arms and interventions

ArmTypeInterventionsDescription
High torque insertionExperimentalProcedure: High torque insertionHigh torque insertion
Low torque insertionActive comparatorProcedure: Low torque insertionLow torque insertion
  • High torque insertion (Procedure), also known as Osseotite endosseous dental implant: Osseotite implant placed with high insertion torque forces
  • Low torque insertion (Procedure), also known as Osseotite endosseous dental implant: Osseotite implant placed with low insertion torque forces

+Outcome measures

Primary outcomes

  • primary stability countertorque measures [4 months]: resistance to countertorque measures showing primary stability success of implants

Secondary outcomes

  • cumulative success rate [1 year]: Crestal bone regression (amount of bone loss measured) and equivalence in integration success (implant mobility)

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

FacilityCityCountryStatus
Universidad JaverianaBogotáColombia

+Investigators