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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Periodontal Diseases Other: DFDBA Device: Regenafil Phase 2 Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Regenerative Therapy for Vertical Defects Comparing Demineralized Freeze Dried Bone Allograft (DFDBA) and Regenafil
Study Start Date : January 2006
Actual Primary Completion Date : November 2007
Actual Study Completion Date : November 2007
Arms and Interventions
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Arm Intervention/treatment
Experimental: Regenafil graft
Regenafil
 Device: Regenafil
Demineralized Freeze Dried Bone in a porcine gel carrier
Other Name: Demineralized Freeze Dried Bone Allograft
Active Comparator: DFDBA
Demineralized Freeze Dried Bone Allograft
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. Recession [ Time Frame: 6 months ]
    CEJ to gingival margin (GM). GM coronal to the CEJ were scored as a negative number.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


  4. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00255970


Locations
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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 Surgical
Investigators
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Principal Investigator: Henry Greenwell, DMD University of Louisville
Principal Investigator: Steven Blanchard, DDS Indiana University
More Information
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Responsible Party: Sponsor, Regeneration Technologies, Inc
ClinicalTrials.gov Identifier: NCT00255970    
Other Study ID Numbers: RegenF052005
First Posted: November 21, 2005    Key Record Dates
Results First Posted: August 5, 2011
Last Update Posted: August 10, 2011
Last Verified: August 2011
Keywords provided by RTI Surgical:
Periodontal Treatment of Intraosseous Vertical Defects
Additional relevant MeSH terms:
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Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases