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OpenTrials
Completed

NCT Number: NCT01529801

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

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

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Key information

Conditions

Partial Edentulism Stomatognathic Diseases Tooth Disease Tooth Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital San Jose

Santiago, Chile

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Osseotite Certain Tapered Group A

Device

Osseotite Certain Tapered with different surface roughness

Other names: Osseotite endosseous dental implant

Osseotite Certain Tapered Group B

Device

Osseotite Certain Tapered with different surface roughness

Other names: Osseotite endosseous dental implant

Osseotite Certain Tapered Group C

Device

Osseotite Certain Tapered with different surface roughness

Other names: osseotite endosseous dental implant

Primary outcomes

  1. Primary stability countertorque measures

    Time frame: 6 weeks

    Resistance to countertorque measures showing primary stability and success of the implant

Secondary outcomes

  1. Cumulative success rate

    Time frame: 2 years

    Crestal bone regression (amount of bone loss measured) and equivalence in integration success (implant mobility)

Sponsors and collaborators

Lead sponsor

ZimVie

Industry

Registry information

Official study title

A Prospective Randomized-controlled Study of the Effect of Surface Topographies on Implant Integration Rates and Clinical Success

Acronym: Luna

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Feb 9, 2012
Registry last updated
Mar 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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