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

This study has been completed.
Sponsor:
Information provided by:
RTI Biologics
ClinicalTrials.gov Identifier:
NCT00255970
First received: November 16, 2005
Last updated: August 8, 2011
Last verified: August 2011
  Purpose

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 Intervention Phase
Periodontal Diseases
Other: DFDBA
Device: Regenafil
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Regenerative Therapy for Vertical Defects Comparing Demineralized Freeze Dried Bone Allograft (DFDBA) and Regenafil

Further study details as provided by RTI Biologics:

Primary Outcome Measures:
  • Change in Probing Depth [ Time Frame: baseline and then at 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    CEJ to gingival margin (GM). GM coronal to the CEJ were scored as a negative number.


Secondary Outcome Measures:
  • Gingival Index [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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.


Enrollment: 40
Study Start Date: January 2006
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Regenafil graft
Regenafil
Device: Regenafil
Demineralized Freeze Dried Bone in a porcine gel carrier
Other Names:
  • Demineralized Freeze Dried Bone Allograft
  • Regenafil
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 Names:
  • Demineralized Freeze Dried Bone Allograft
  • Regenafil

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00255970

Locations
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 Biologics
Investigators
Principal Investigator: Henry Greenwell, DMD University of Louisville
Principal Investigator: Steven Blanchard, DDS Indiana University School of Dentistry
  More Information

No publications provided

Responsible Party: Sponsor, Regeneration Technologies, Inc
ClinicalTrials.gov Identifier: NCT00255970     History of Changes
Other Study ID Numbers: RegenF052005
Study First Received: November 16, 2005
Results First Received: June 9, 2009
Last Updated: August 8, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by RTI Biologics:
Periodontal Treatment of Intraosseous Vertical Defects

Additional relevant MeSH terms:
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on April 16, 2014