NCT01529762

Brief Summary

Osseotite Certain Tapered implants placed in immediate prosthesis loaded cases.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 7, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 9, 2012

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

March 28, 2022

Status Verified

March 1, 2022

Enrollment Period

5.9 years

First QC Date

February 7, 2012

Last Update Submit

March 24, 2022

Conditions

Partial EdentulismTooth Disease

Keywords

edentulismdental implantsOsseotite Certain Taperedrandomizedclinical studypartial edentulismimmediate loadingcrestal bone level

Outcome Measures

Primary Outcomes (1)

  • cumulative success rate

    An implant will be considered successful if it is immobile at various study points in time

    3 years

Study Arms (1)

Osseotite Certain Tapered

Dental implant Osseotite Certain Tapered design

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with partial edentulism needing a minimum of one dental implant restored immediately (same visit)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad San Sebastian

Santiago, Chile

Location

MeSH Terms

Conditions

Tooth Diseases

Condition Hierarchy (Ancestors)

Stomatognathic Diseases

Study Officials

  • Fernando Fuentes, DDS

    Universidad San Sebastian

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2012

First Posted

February 9, 2012

Study Start

January 1, 2011

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

March 28, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

CL(1)