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Regenafil Versus Demineralized Freeze Dried Bone Allograft (DFDBA) for Periodontal Defects

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ClinicalTrials.gov Identifier: NCT00255970
Recruitment Status : Completed
First Posted : November 21, 2005
Results First Posted : August 5, 2011
Last Update Posted : August 10, 2011
Sponsor:
Information provided by:
RTI Surgical

Tracking Information
First Submitted Date  ICMJE November 16, 2005
First Posted Date  ICMJE November 21, 2005
Results First Submitted Date  ICMJE June 9, 2009
Results First Posted Date  ICMJE August 5, 2011
Last Update Posted Date August 10, 2011
Study Start Date  ICMJE January 2006
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 12, 2011)
  • Change in Probing Depth [ Time Frame: baseline and then at 6 months ]
    This is the distance, measured in millimeters (mm) from the gingival margin to the maximal penetration of the probe tip. The measures were made at baseline and then at 6 months after treatment.
  • Clinical Attachment Level [ Time Frame: 6 months ]
    The amount of space between attached periodontal tissues and a fixed point, usually the cementoenamel junction. A measurement used to assess the stability of attachment as part of a periodontal maintenance program.
  • Recession [ Time Frame: 6 months ]
    CEJ to gingival margin (GM). GM coronal to the CEJ were scored as a negative number.
Original Primary Outcome Measures  ICMJE
 (submitted: November 16, 2005)
  • 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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 12, 2011)
  • Gingival Index [ Time Frame: 6 months ]
    Scores: 0 Normal gingiva
    1. Mild inflammation
    2. Moderate inflammation
    3. Severe inflammation Gingival units (buccal, lingual, mesiobuccal, distobuccal, mesiolingual, and distolingual) of each tooth were scored 0-3. Scores from the 6 areas of the tooth were added and divided by 6 to give the gingival index for the entire tooth.
  • Plaque Index [ Time Frame: 6 months ]
    0- No plaque
    1. A film of plaque adhering to gingival margin & adjacent area of tooth
    2. Moderate accumulation of soft deposits, visible with the naked eye
    3. Abundance of soft matter Each gingival region of the individual tooth will be scored 0-3 The scores from the 6 areas of the tooth are averaged to give the plaque index for the tooth.
  • Bleeding on Probing [ Time Frame: 6 months ]
    The variable measured the presence of bleeding when the osseus defect was probed. The presence and character of gingival bleeding will be determined by gently probing to the base of the pockets. 0 - No bleeding. 1 - Bleeding when probing.
  • Mobility Index [ Time Frame: 6 months ]
    Tooth mobility was recorded using Miller's Index:
    1. - up to 1 mm of movement in a horizontal direction
    2. - greater than 1 mm of movement in a horizontal direction
    3. - excessive horizontal movement and vertical movement. Manual evaluation of mobility was carried out clinically using the handles of two instruments to move the teeth buccally and lingually and note their movement.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Regenafil Versus Demineralized Freeze Dried Bone Allograft (DFDBA) for Periodontal Defects
Official Title  ICMJE Regenerative Therapy for Vertical Defects Comparing Demineralized Freeze Dried Bone Allograft (DFDBA) and Regenafil
Brief Summary The purpose of this research study was to determine whether treatment with the bone grafting material Regenafil was as effective as the standard treatment using demineralized freeze dried bone allograft (DFDBA). 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 care. To compare the regenerative effects of a demineralized freeze dried bone allograft (DFDBA) particulate in the treatment of intraosseous vertical defects following six months of healing. This was 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Periodontal Diseases
Intervention  ICMJE
  • Other: DFDBA
    Demineralized Freeze Dried Allograft bone
    Other Name: Demineralized Bone Matrix
  • Device: Regenafil
    Demineralized Freeze Dried Bone in a porcine gel carrier
    Other Name: Demineralized Freeze Dried Bone Allograft
Study Arms  ICMJE
  • Experimental: Regenafil graft
    Regenafil
    Intervention: Device: Regenafil
  • Active Comparator: DFDBA
    Demineralized Freeze Dried Bone Allograft
    Interventions:
    • Other: DFDBA
    • Device: Regenafil
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 16, 2005)
40
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2007
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00255970
Other Study ID Numbers  ICMJE RegenF052005
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sponsor, Regeneration Technologies, Inc
Study Sponsor  ICMJE RTI Surgical
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Henry Greenwell, DMD University of Louisville
Principal Investigator: Steven Blanchard, DDS Indiana University
PRS Account RTI Surgical
Verification Date August 2011

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