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Regenafil Versus Demineralized Freeze Dried Bone Allograft for Periodontal Defects

This study is currently recruiting patients

Verified by Regeneration Technologies February 2006

Sponsored by: Regeneration Technologies
Information provided by: Regeneration Technologies
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
Device: Regenafil
Phase II
Phase III

Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, 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 Regeneration Technologies:
Primary Outcomes: Evaluating clinical parameters, over 6 months, including probing depth, attachment 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
Expected Total Enrollment:  40

Study start: January 2006

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.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

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.

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00255970


Indiana
Indiana University School of Dentistry, Indianapolis,  Indiana,  46202,  United States; Recruiting Steven Blanchard, DDS  317-274-5129 
Steven Blanchard, DDS,  Principal Investigator

Kentucky
University of Louisville School of Dentistry, Louisville,  Kentucky,  40202,  United States; Recruiting Henry Greenwell, DMD  502-852-6928 
Margaret Hill, DMD  (502) 852-6928 
Henry Greenwell, DMD,  Principal Investigator
Margaret Hill, DMD,  Sub-Investigator

Study chairs or principal investigators
Henry Greenwell, DMD,  Principal Investigator,  University of Louisville   
Steven Blanchard, DDS,  Principal Investigator,  Indiana University School of Dentistry   

More Information

Study ID Numbers:  RegenF052005
Last Updated:  September 28, 2006
Record first received:  November 16, 2005
ClinicalTrials.gov Identifier:  NCT00255970
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-09-29





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