DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Biomet, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Partial Edentulism; Tooth Disease

Intervention: High torque insertion (Procedure); Low torque insertion (Procedure)

Phase: N/A

Status: Active, not recruiting

Sponsored by: Biomet, Inc.

Official(s) and/or principal investigator(s):
Armando Estefan, DMD, Principal Investigator, Affiliation: Universidad Javeriana

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Primary outcome: primary stability countertorque measures

Secondary outcome: cumulative success rate

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Universidad Javeriana, Bogota, Colombia
Additional Information

Starting date: December 2010
Last updated: July 27, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017