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

Prospective Randomized-controlled Study of the Integration Success of Osseotite Implants Placed With Different Insertion Procedures

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01529736

Acronym

Pegasus

Enrollment

Registered

2012-02-09

Start date

2010-12-31

Completion date

2016-12-31

Last updated

2022-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Partial Edentulism, Tooth Disease

Keywords

edentulism, dental implants, early loading, crestal bone level, high torque insertion, low torque insertion, randomized, Osseotite, clinical study

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.

Interventions

PROCEDUREHigh torque insertion

Osseotite implant placed with high insertion torque forces

PROCEDURELow torque insertion

Osseotite implant placed with low insertion torque forces

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
primary stability countertorque measures	4 months	resistance to countertorque measures showing primary stability success of implants

Secondary

Measure	Time frame	Description
cumulative success rate	1 year	Crestal bone regression (amount of bone loss measured) and equivalence in integration success (implant mobility)

Countries

Colombia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026