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

NCT ID: NCT01529736

Last Updated: 2022-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2016-12-31

Brief Summary

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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

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

Conditions

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Partial Edentulism Tooth Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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High torque insertion

High torque insertion

Group Type EXPERIMENTAL

High torque insertion

Intervention Type PROCEDURE

Osseotite implant placed with high insertion torque forces

Low torque insertion

Low torque insertion

Group Type ACTIVE_COMPARATOR

Low torque insertion

Intervention Type PROCEDURE

Osseotite implant placed with low insertion torque forces

Interventions

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High torque insertion

Osseotite implant placed with high insertion torque forces

Intervention Type PROCEDURE

Low torque insertion

Osseotite implant placed with low insertion torque forces

Intervention Type PROCEDURE

Other Intervention Names

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Osseotite endosseous dental implant Osseotite endosseous dental implant

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ZimVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Armando Estefan, DMD

Role: PRINCIPAL_INVESTIGATOR

Universidad Javeriana

Locations

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Universidad Javeriana

Bogotá, , Colombia

Site Status

Countries

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Colombia

Other Identifiers

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3004

Identifier Type: -

Identifier Source: org_study_id

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