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

ZimVie

Status: Completed

Conditions: Tooth Disease; Partial Edentulism

Treatments: Procedure: High torque insertion; Procedure: Low torque insertion

Study type: Interventional

Funder types: Industry

Identifiers

NCT01529736

3004

Details and patient eligibility

About

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.

Full description

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

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

High torque insertion

Experimental group

Description:

High torque insertion

Treatment:

Procedure: High torque insertion

Low torque insertion

Active Comparator group

Description:

Low torque insertion

Treatment:

Procedure: Low torque insertion