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

NCT ID: NCT00255970

Last Updated: 2011-08-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2007-11-30

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.

Conditions

Periodontal Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Regenafil graft

Regenafil

Group Type: EXPERIMENTAL

Regenafil

Intervention Type: DEVICE

Demineralized Freeze Dried Bone in a porcine gel carrier

DFDBA

Demineralized Freeze Dried Bone Allograft

Group Type: ACTIVE_COMPARATOR

DFDBA

Intervention Type: OTHER

Demineralized Freeze Dried Allograft bone

Regenafil

Intervention Type: DEVICE

Demineralized Freeze Dried Bone in a porcine gel carrier

Interventions

DFDBA

Demineralized Freeze Dried Allograft bone

Intervention Type: OTHER

Regenafil

Demineralized Freeze Dried Bone in a porcine gel carrier

Intervention Type: DEVICE

Other Intervention Names

Demineralized Bone Matrix; Demineralized Freeze Dried Bone Allograft

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

RTI Surgical

INDUSTRY

Sponsor Role: lead

Responsible Party

Regeneration Technologies, Inc

Principal Investigators

Henry Greenwell, DMD

Role: PRINCIPAL_INVESTIGATOR

University of Louisville

Steven Blanchard, DDS

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

Indiana University School of Dentistry

Indianapolis, Indiana, United States

University of Louisville School of Dentistry

Louisville, Kentucky, United States

Countries

United States

Other Identifiers

RegenF052005

Identifier Type: -

Identifier Source: org_study_id