Ridge Preservation Comparing 2 Membranes | NCT01905280

Studies
Ridge Preservation Comparing 2 Membranes

NCT01905280

Sponsor

University of Louisville

Status

Completed

Last Update Posted

Dec 8, 2016Estimated

Enrollment

24Actual

Phase

Not Applicable

Conditions

Alveolar Ridge Deficiency

Interventions

Non-resorbable membrane
Acellular dermal matrix

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

Dec 2016

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

Sep 2013

Primary Completion Date

Jul 2014Actual

Completion Date

Jul 2014Actual

First Submitted Date

Jul 12, 2013

First Submission Date that Met QC Criteria

Jul 18, 2013

First Posted Date

Jul 23, 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

The purpose of this study is to compare the clinical and histologic outcomes for acellular dermal matrix and a nonresorbable membrane to determine if either provides a significant therapeutic advantage. The hypothesis is that there will be no difference in crestal ridge width between the two treatments.

Detailed Description

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

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Acellular dermal matrix	Experimental	A ridge preservation graft will be performed and then covered using acellular dermal matrix as a membrane.	Procedure: Acellular dermal matrix
Non-resorbable membrane	Active Comparator	A ridge preservation graft will be performed and then covered using a non-resorbable PTFE membrane.	Procedure: Non-resorbable membrane

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Non-resorbable membrane	Procedure	The ridge preservation graft will be covered with a non-resorbable PTFE membrane during the surgery.	Non-resorbable membrane

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Crestal ridge width	The width of the ridge at the crest will be measured with a digital caliper.	4 months

Secondary Outcomes

Measure	Description	Time Frame
Percent vital bone	Percent vital bone at the graft site will be determined from a trephine core sample.	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 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

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Henry Greenwell, DMD	University of Louisville	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Graduate Periodontics Clinic University of Louisville		Louisville	Kentucky	40202	United States

Intervention Browse Module

MeSH Terms

ID	Term
D011138	Polytetrafluoroethylene
C440568	Alloderm

Ancestor Terms

ID	Term
D005465	Fluorocarbon Polymers
D011108	Polymers
D046911	Macromolecular Substances
D001697	Biomedical and Dental Materials

Browse Leaves

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Browse Branches

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