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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 4 April 2022
Main ID:  NCT01529801
Date of registration: 07/02/2012
Prospective Registration: No
Primary sponsor: ZimVie
Public title: Assessment of the Effect of a Novel Surface Roughness Treatment on Dental Implants on Integration Success Luna
Scientific title: A Prospective Randomized-controlled Study of the Effect of Surface Topographies on Implant Integration Rates and Clinical Success
Date of first enrolment: February 2011
Target sample size: 80
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT01529801
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Investigator).  
Phase:  N/A
Countries of recruitment
Chile
Contacts
Name:     Jaime Acuna, DDS
Address: 
Telephone:
Email:
Affiliation:  Hospital San Jose
Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Tooth Disease
Partial Edentulism
Intervention(s)
Device: Osseotite Certain Tapered Group C
Device: Osseotite Certain Tapered Group A
Device: Osseotite Certain Tapered Group B
Primary Outcome(s)
Primary stability countertorque measures [Time Frame: 6 weeks]
Secondary Outcome(s)
Cumulative success rate [Time Frame: 2 years]
Secondary ID(s)
3011
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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