Clinical trial NCT00255970: Regenafil Versus Demineralized Freeze Dried Bone Allograft (DFDBA) for Periodontal Defects
Official title: Regenerative Therapy for Vertical Defects Comparing Demineralized Freeze Dried Bone Allograft (DFDBA) and Regenafil
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Periodontal Diseases
Keywords: Periodontal Treatment of Intraosseous Vertical Defects
Lead sponsor: RTI Surgical
Sponsor class: INDUSTRY
First posted: 2005-11-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Change in Probing Depth
timeFrame: baseline and then at 6 months
measure: Clinical Attachment Level
timeFrame: 6 months
measure: Recession
timeFrame: 6 months
Secondary outcomes:
measure: Gingival Index
timeFrame: 6 months
measure: Plaque Index
timeFrame: 6 months
measure: Bleeding on Probing
timeFrame: 6 months
measure: Mobility Index
timeFrame: 6 months
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University School of Dentistry
state: Indiana
city: Louisville
country: United States
facility: University of Louisville School of Dentistry
state: Kentucky
Study officials:
affiliation: University of Louisville
name: Henry Greenwell, DMD
role: PRINCIPAL_INVESTIGATOR
affiliation: Indiana University
name: Steven Blanchard, DDS
role: PRINCIPAL_INVESTIGATOR
References: