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Regenafil Versus Demineralized Freeze Dried Bone Allograft for Periodontal Defects

This study has been completed.
Study NCT00255970.   Last updated on October 2, 2008.   Information provided by RTI Biologics

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Descriptive Information Fields
Brief Title  Regenafil Versus Demineralized Freeze Dried Bone Allograft for Periodontal Defects
Official Title  Regenerative Therapy for Vertical Defects Comparing Demineralized Freeze Dried Bone Allograft and Regenafil
Brief Summary

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.

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:

  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.

Study Phase Phase II, Phase III
Study Type  Interventional
Study Design  Prevention, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
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 ]
Secondary Outcome Measure 
Condition  Periodontal Diseases
Intervention  Other: DFDBA
Device: Regenafil
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  40
Start Date  January 2006
Completion Date November 2007
Eligibility Criteria 

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.
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers Yes
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00255970
Organization ID RegenF052005
Secondary IDs ††
Study Sponsor  RTI Biologics
Collaborators ††
Investigators 
Principal Investigator:     Henry Greenwell, DMD     University of Louisville    
Principal Investigator:     Steven Blanchard, DDS     Indiana University School of Dentistry    
Information Provided By RTI Biologics
Verification Date October 2008
First Received Date  November 16, 2005
Last Updated Date October 2, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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