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

RTI Surgical

Status and phase: Completed; Phase 3; Phase 2

Conditions: Periodontal Diseases

Treatments: Device: Regenafil; Other: DFDBA

Study type: Interventional

Funder types: Industry

Identifiers

NCT00255970

RegenF052005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Regenafil graft

Experimental group

Description:

Regenafil

Treatment:

Device: Regenafil

DFDBA

Active Comparator group

Description:

Demineralized Freeze Dried Bone Allograft

Treatment:

Device: Regenafil

Other: DFDBA