Regenafil Versus Demineralized Freeze Dried Bone Allograft for Periodontal Defects - Full Text View

Sponsored by:	RTI Biologics
Information provided by:	RTI Biologics
ClinicalTrials.gov Identifier:	NCT00255970

Purpose

The purpose of this research study is to determine whether treatment with the bone grafting material Regenafil is as effective as the standard treatment using demineralized freeze dried bone. Regenafil is demineralized freeze dried bone in a special gel form.

Condition	Intervention	Phase
Periodontal Diseases	Other: DFDBA Device: Regenafil	Phase II Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Regenerative Therapy for Vertical Defects Comparing Demineralized Freeze Dried Bone Allograft and Regenafil

Further study details as provided by RTI Biologics:

Primary Outcome Measures:

Evaluating clinical parameters, over 6 months, including probing depth, attachment level and bleeding upon probing [ Time Frame: Done at visit pre-op, bi-weekly for weeks post-op, 12 week post-op, 20 week post-op and 24 week post-op ]

Enrollment:	40
Study Start Date:	January 2006
Study Completion Date:	November 2007
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Regenafil	Device: Regenafil Demineralized Freeze Dried Bone in a porcine gel carrier
2: Active Comparator DFDBA	Other: DFDBA Demineralized Freeze Dried Allograft bone

Detailed Description:

To compare the regenerative effects of a demineralized freeze dried bone allograft (DFDBA) particulate in a biologic thermoplastic carrier (Regenafil) to the standard of DFDBA particulate in the treatment of intraosseous vertical defects following six months of healing. This will be accomplished by evaluating clinical parameters including probing depth, attachment level and bleeding upon probing, using attachment level as the primary outcome variable.

Treatment of the vertical osseous defect is a challenging problem in periodontics. There are many treatment options including:

open flap debridement;
osseous graft alone;
membrane alone;
or membrane plus an osseous graft.

Choice of treatment may depend on the defect depth and configuration. A shallow, narrow 3 wall defect may respond well to open flap debridement while a deep 2 wall defect may need regenerative therapy such as an osseous graft, a membrane or combined membrane and graft treatment. Studies of vertical defect therapy with defects about 4 mm or greater show that similar percent defect fill results are obtained with regenerative therapies.

Open flap debridement produces substantially less percent defect fill.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Provide written informed consent prior to their participation.
Be an adult age 18 and older.
Have at least a 4 mm open vertical osseous defect depth on one tooth, visible on a radiograph and with a probing depth ≥ 5 mm.
Have osseous defects that are either wide 3-wall, or combination defects.

Exclusion Criteria:

Have debilitating systemic diseases, or diseases that affect the periodontium.
Have a known allergy to any of the materials that will be used in the study:
- non-steroidal anti-inflammatory drugs (NSAIDs)
- chlorhexidine digluconate
- doxycycline
- gelatin
Need prophylactic antibiotics.
Have a vertical osseous defect that is related to a furcation area.
Smoke more than 1 pack per day.
Have endodontically treated teeth or endodontic lesions at study sites.
Have 1-wall defects.
Have poor oral hygiene.
Have anterior fillings (Note: if a subject presents with anterior fillings, it will be at the discretion of the principal investigator as to whether they should be accepted into the study.)
Be pregnant as evidenced by a positive urine pregnancy test taken at both the screening and baseline visits.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00255970

Locations

United States, Indiana
Indiana University School of Dentistry
Indianapolis, Indiana, United States, 46202
United States, Kentucky
University of Louisville School of Dentistry
Louisville, Kentucky, United States, 40202

Sponsors and Collaborators

RTI Biologics

Investigators

Principal Investigator:	Henry Greenwell, DMD	University of Louisville
Principal Investigator:	Steven Blanchard, DDS	Indiana University School of Dentistry

More Information

No publications provided

Responsible Party:	Regeneration Technologies, Inc ( Sponsor )
Study ID Numbers:	RegenF052005
Study First Received:	November 16, 2005
Last Updated:	October 2, 2008
ClinicalTrials.gov Identifier:	NCT00255970 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by RTI Biologics:

Periodontal Treatment of Intraosseous Vertical Defects

Study placed in the following topic categories:

Mouth Diseases
Periodontal Diseases
Stomatognathic Diseases

Additional relevant MeSH terms:

Mouth Diseases
Periodontal Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on September 02, 2009