|
Main
|
|
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: |
NCT01529775 |
|
Date of registration:
|
07/02/2012 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Randomized Study of Osseotite Certain Tapered Prevails vs. Osseotite Certain Tapered
Bolivar |
|
Scientific title:
|
A Prospective Randomized-controlled Evaluation of the Osseotite Certain Tapered Prevail Implant for the Preservation of Crestal Bone |
|
Date of first enrolment:
|
November 2010 |
|
Target sample size:
|
92 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT01529775 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Chile
| | | | | | | |
|
Contacts
|
|
Name:
|
Manuel Pavez, DDS |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Universidad Finis Terrae |
| | |
|
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
|
|
Device: Osseotite Certain Tapered Prevail
|
|
Primary Outcome(s)
|
|
Cumulative Success Rate
[Time Frame: 3 years]
|
|
Secondary Outcome(s)
|
|
Crestal Bone Regression
[Time Frame: 3 years]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|