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

ZimVie

Status: Completed

Conditions: Tooth Disease; Partial Edentulism

Treatments: Device: Osseotite Certain Tapered Group A; Device: Osseotite Certain Tapered Group B; Device: Osseotite Certain Tapered Group C

Study type: Interventional

Funder types: Industry

Identifiers

NCT01529801

3011

Details and patient eligibility

About

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

Full description

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

Enrollment: 80 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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 3 patient groups

Roughness group A

Experimental group

Description:

Osseotite Certain Tapered Group A

Treatment:

Device: Osseotite Certain Tapered Group A

Roughness Group B

Experimental group

Description:

Osseotite Certain Tapered Group B

Treatment:

Device: Osseotite Certain Tapered Group B

Roughness Group C

Experimental group

Description:

Osseotite Certain Tapered Group C

Treatment:

Device: Osseotite Certain Tapered Group C