NCT01900964

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2012

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

October 1, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 10, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 17, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

December 8, 2016

Status Verified

May 1, 2014

Enrollment Period

1.1 years

First QC Date

July 10, 2013

Last Update Submit

December 6, 2016

Conditions

Clinical Efficacy

Keywords

RegenerationBone regenerationGrafting, BoneAllograftXenograft

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Percent vital bone

    Time 4 months

Study Arms (2)

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

PTFE membranePROCEDURE

The non-resorbable PTFE barrier membrane will be surgically placed in conjunction with a ridge preservation procedure.

PTFE membrane
Collagen membranePROCEDURE

A resorbable collagen membrane is surgically placed in conjunction with a ridge preservation procedure.

Collagen membrane

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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. -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Graduate Periodontics Clinic, University of Louisville

Louisvile, Kentucky, 40202, United States

Location

Study Officials

  • Henry Greenwell, DMD

    University of Louisville

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 10, 2013

First Posted

July 17, 2013

Study Start

October 1, 2012

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

December 8, 2016

Record last verified: 2014-05

Locations

US(1)