NCT01588444

Brief Summary

The purpose of this study is to compare cortical and cancellous freeze-dried bone allograft (FDBA) materials in the preservation of alveolar bone following extraction of non-molar teeth. The primary objective is to histologically evaluate and compare the healing of extraction sockets of non-molar teeth grafted with cortical FDBA versus cancellous FDBA for ridge preservation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2010

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, 2010

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

March 16, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 1, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

October 6, 2014

Completed
Last Updated

October 22, 2015

Status Verified

October 1, 2015

Enrollment Period

1.8 years

First QC Date

March 16, 2012

Results QC Date

October 1, 2014

Last Update Submit

October 1, 2015

Conditions

Keywords

tooth extractionbone grafting

Outcome Measures

Primary Outcomes (1)

  • Histologic Percentage of Vital Bone Formation

    Histologic percentage of vital bone formation in bone cores

    18-20 weeks after grafting

Study Arms (2)

cancellous FDBA (LifeNet)

EXPERIMENTAL

grafting with cancellous mineralized freeze-dried bone allograft (LifeNet Health)

Device: Cancellous FDBA

cortical FDBA (LifeNet)

EXPERIMENTAL

CORTICAL FREEZE-DRIED BONE ALLOGRAFT (from LifeNet Health)

Device: cortical FDBA

Interventions

cortical mineralized freeze-dried bone allograft

cortical FDBA (LifeNet)

CANCELLOUS FREEZE-DRIED BONE ALLOGRAFT (from LifeNet Health)

cancellous FDBA (LifeNet)

Eligibility Criteria

Age19 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • single rooted tooth requiring extraction with future dental implant placement

You may not qualify if:

  • smoking \> 10 cigarettes per day poorly controlled diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT Health Science Center Dental School

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

  • Eskow AJ, Mealey BL. Evaluation of healing following tooth extraction with ridge preservation using cortical versus cancellous freeze-dried bone allograft. J Periodontol. 2014 Apr;85(4):514-24. doi: 10.1902/jop.2013.130178. Epub 2013 May 31.

Results Point of Contact

Title
Dr. Brian Mealey
Organization
UT Health Sci Ctr San Antonio

Study Officials

  • Brian L Mealey, DDS, MS

    The University of Texas Health Science Center at San Antonio

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2012

First Posted

May 1, 2012

Study Start

October 1, 2010

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

October 22, 2015

Results First Posted

October 6, 2014

Record last verified: 2015-10

Locations