Assessment of the Effect of a Novel Surface Roughness Treatment on Dental Implants on Integration Success

NCT ID: NCT01529801

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

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2016-11-30

Brief Summary

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A study where dental implants with different roughened surfaces will be evaluated for the ability to resist countertorque forces.

Detailed Description

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This study on dental implants with different roughened surfaces will assess its ability to resist countertorque testing at various study time points and demonstrate high success

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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Roughness group A

Osseotite Certain Tapered Group A

Group Type EXPERIMENTAL

Osseotite Certain Tapered Group A

Intervention Type DEVICE

Osseotite Certain Tapered with different surface roughness

Roughness Group B

Osseotite Certain Tapered Group B

Group Type EXPERIMENTAL

Osseotite Certain Tapered Group B

Intervention Type DEVICE

Osseotite Certain Tapered with different surface roughness

Roughness Group C

Osseotite Certain Tapered Group C

Group Type EXPERIMENTAL

Osseotite Certain Tapered Group C

Intervention Type DEVICE

Osseotite Certain Tapered with different surface roughness

Interventions

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Osseotite Certain Tapered Group A

Osseotite Certain Tapered with different surface roughness

Intervention Type DEVICE

Osseotite Certain Tapered Group B

Osseotite Certain Tapered with different surface roughness

Intervention Type DEVICE

Osseotite Certain Tapered Group C

Osseotite Certain Tapered with different surface roughness

Intervention Type DEVICE

Other Intervention Names

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Osseotite endosseous dental implant 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 at least one dental implant 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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Jaime Acuna, DDS

Role: PRINCIPAL_INVESTIGATOR

Hospital San Jose

Locations

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Hospital San Jose

Santiago, , Chile

Site Status

Countries

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Chile

Other Identifiers

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3011

Identifier Type: -

Identifier Source: org_study_id

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