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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01529801
Acronym
Luna
Enrollment
80
Registered
2012-02-09
Start date
2011-02-28
Completion date
2016-11-30
Last updated
2022-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Partial Edentulism, Tooth Disease

Keywords

edentulism, dental implants, clinical study, randomized, Osseotite Certain Tapered, Crestal bone level

Brief summary

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

Detailed 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

Interventions

DEVICEOsseotite Certain Tapered Group A

Osseotite Certain Tapered with different surface roughness

DEVICEOsseotite Certain Tapered Group B

Osseotite Certain Tapered with different surface roughness

DEVICEOsseotite Certain Tapered Group C

Osseotite Certain Tapered with different surface roughness

Sponsors

ZimVie
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Primary stability countertorque measures6 weeksResistance to countertorque measures showing primary stability and success of the implant

Secondary

MeasureTime frameDescription
Cumulative success rate2 yearsCrestal bone regression (amount of bone loss measured) and equivalence in integration success (implant mobility)

Countries

Chile

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026