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Regenafil Versus Demineralized Freeze Dried Bone Allograft for Periodontal Defects
This study has been completed.
Study NCT00255970   Information provided by RTI Biologics
First Received: November 16, 2005   Last Updated: October 2, 2008   History of Changes

November 16, 2005
October 2, 2008
January 2006
November 2007   (final data collection date for primary outcome measure)
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 ]
  • Evaluating clinical parameters, over 6 months, including probing depth, attachement level and bleeding upon probing.
  • Done at visit pre-op,bi-weekly for weeks post op, 12 week post op, 20 week post-op and 24 week post-op
Complete list of historical versions of study NCT00255970 on ClinicalTrials.gov Archive Site
 
 
 
Regenafil Versus Demineralized Freeze Dried Bone Allograft for Periodontal Defects
Regenerative Therapy for Vertical Defects Comparing Demineralized Freeze Dried Bone Allograft and Regenafil

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.

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:

  1. open flap debridement;
  2. osseous graft alone;
  3. membrane alone;
  4. 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.

Phase II, Phase III
Interventional
Prevention, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Periodontal Diseases
  • Other: DFDBA
  • Device: Regenafil
  • Experimental: Regenafil
  • Active Comparator: DFDBA
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
40
November 2007
November 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Provide written informed consent prior to their participation.
  2. Be an adult age 18 and older.
  3. 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.
  4. Have osseous defects that are either wide 3-wall, or combination defects.

Exclusion Criteria:

  1. Have debilitating systemic diseases, or diseases that affect the periodontium.
  2. 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
  3. Need prophylactic antibiotics.
  4. Have a vertical osseous defect that is related to a furcation area.
  5. Smoke more than 1 pack per day.
  6. Have endodontically treated teeth or endodontic lesions at study sites.
  7. Have 1-wall defects.
  8. Have poor oral hygiene.
  9. 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.)
  10. Be pregnant as evidenced by a positive urine pregnancy test taken at both the screening and baseline visits.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00255970
Sponsor, Regeneration Technologies, Inc
RegenF052005
RTI Biologics
 
Principal Investigator: Henry Greenwell, DMD University of Louisville
Principal Investigator: Steven Blanchard, DDS Indiana University School of Dentistry
RTI Biologics
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP