Randomized Study of Integration Success of Osseotite Dent... | NCT01529736

Studies
Randomized Study of Integration Success of Osseotite Dental Implants Placed Using Different Insertion Procedures

NCT01529736

Sponsor

ZimVie

Status

Completed

Last Update Posted

Mar 28, 2022Actual

Enrollment

60Actual

Phase

Not Applicable

Conditions

Partial Edentulism
Tooth Disease

Interventions

High torque insertion
Low torque insertion

Countries

Colombia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2010

Primary Completion Date

Dec 2016Actual

Completion Date

Dec 2016Actual

First Submitted Date

Feb 7, 2012

First Submission Date that Met QC Criteria

Feb 7, 2012

First Posted Date

Feb 9, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 24, 2022

Last Update Posted Date

Mar 28, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Osseotite implants placed with higher insertion torque (TEST procedure) will have higher initial stability and integration success than those placed with lower insertion torque forces.

Detailed Description

Osseotite implants will be placed using the standard lower insertion torque forces and compared to implants placed using higher insertion torque forces.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
High torque insertion	Experimental	High torque insertion	Procedure: High torque insertion
Low torque insertion	Active Comparator	Low torque insertion	Procedure: Low torque insertion

Interventions

Name	Type	Description	Arm Group Labels	Other Names
High torque insertion	Procedure	Osseotite implant placed with high insertion torque forces	High torque insertion

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
primary stability countertorque measures	resistance to countertorque measures showing primary stability success of implants	4 months

Secondary Outcomes

Measure	Description	Time Frame
cumulative success rate	Crestal bone regression (amount of bone loss measured) and equivalence in integration success (implant mobility)	1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients of either sex and older than 18 years of age
patients needing a minimum of 3 implants 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Armando Estefan, DMD	Universidad Javeriana	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universidad Javeriana		Bogotá			Colombia

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided