Ridge Preservation Comparing a PTFE Nonresorbable Membran... | NCT01900964

Studies
Ridge Preservation Comparing a PTFE Nonresorbable Membrane to a Collagen Membrane

NCT01900964

Sponsor

University of Louisville

Status

Completed

Last Update Posted

Dec 8, 2016Estimated

Enrollment

30Actual

Phase

Not Applicable

Conditions

Clinical Efficacy

Interventions

PTFE membrane
Collagen membrane

Countries

United States

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

May 2014

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

Oct 2012

Primary Completion Date

Nov 2013Actual

Completion Date

Nov 2013Actual

First Submitted Date

Jul 10, 2013

First Submission Date that Met QC Criteria

Jul 12, 2013

First Posted Date

Jul 17, 2013Estimated

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

Dec 6, 2016

Last Update Posted Date

Dec 8, 2016Estimated

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

A non-resorbable PTFE (teflon) membrane will be compared to a resorbable collagen membrane when used for a post-extraction ridge preservation procedure to prevent the bone loss that typically occurs. The hypothesis is that there will be no difference in the clinical and histologic results between the two membranes.

Detailed Description

Patient Selection 30 patients will be selected that meet the following criteria:

Inclusion Criteria

Have one non-molar tooth requiring extraction that will be replaced by a dental implant. The site must be bordered by at least one tooth.
Healthy male or female who is at least 18 years old.
Patients must sign an informed consent approved by the University of Louisville Human Studies Committee.

Exclusion Criteria

Patients with debilitating systemic diseases, or diseases that have a clinically significant effect on the periodontium.
Presence or history of osteonecrosis of jaws.
Patients who are currently taking IV bisphosphonates or who had IV treatment with bisphosphonates irrespective of duration.
Patients who have been treated with oral bisphosphonates for more than three years.
Patients with an allergy to any material or medication used in the study.
Patients who need prophylactic antibiotics.
Previous head and neck radiation therapy.
Chemotherapy in the previous 12 months.
Patients on long term NSAID or steroid therapy.
Pregnant patients.

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

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PTFE membrane	Active Comparator	A non-resorbable PTFE (polytetrafluoroethylene) membrane will be used as a positive control treatment.	Procedure: PTFE membrane
Collagen membrane	Experimental	A resorbable collagen membrane will be used in the test group.	Procedure: Collagen membrane

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PTFE membrane	Procedure	The non-resorbable PTFE barrier membrane will be surgically placed in conjunction with a ridge preservation procedure.	PTFE membrane

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Crestal ridge width	The crestal ridge width will be measured with a digital caliper at the baseline exam and at the 4 month examination.	Time 4 months

Secondary Outcomes

Measure	Description	Time Frame
Percent vital bone	A trephine core will be taken at 4 months immediately prior to implant placement from the implant osteotomy site.	Time 4 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Have one non-molar tooth requiring extraction that will be replaced by a dental implant. The site must be bordered by at least one tooth.
Healthy male or female who is at least 18 years old.
Patients must sign an informed consent approved by the University of Louisville Human Studies Committee.

-

Exclusion Criteria:

Patients with debilitating systemic diseases, or diseases that have a clinically significant effect on the periodontium.
Presence or history of osteonecrosis of jaws.
Patients who are currently taking IV bisphosphonates or who had IV treatment with bisphosphonates irrespective of duration.
Patients who have been treated with oral bisphosphonates for more than three years.
Patients with an allergy to any material or medication used in the study.
Patients who need prophylactic antibiotics.
Previous head and neck radiation therapy.
Chemotherapy in the previous 12 months.
Patients on long term NSAID (nonsteroidal anti-inflammatory drug) or steroid therapy.
Pregnant patients. -

Accepts Healthy Volunteers

Yes

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