Regenerative Therapy for Vertical Defects Comparing Demineralized Freeze Dried Bone Allograft (DFDBA) and Regenafil
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Periodontal Diseases
- Sponsor
- RTI Surgical
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Change in Probing Depth
- Status
- Completed
- Last Updated
- 14 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Provide written informed consent prior to their participation.
- •Be an adult age 18 and older.
- •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.
- •Have osseous defects that are either wide 3-wall, or combination defects.
Exclusion Criteria
- •Have debilitating systemic diseases, or diseases that affect the periodontium.
- •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
- •Need prophylactic antibiotics.
- •Have a vertical osseous defect that is related to a furcation area.
- •Smoke more than 1 pack per day.
- •Have endodontically treated teeth or endodontic lesions at study sites.
- •Have 1-wall defects.
Outcomes
Primary Outcomes
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.
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.
Recession
Time Frame: 6 months
CEJ to gingival margin (GM). GM coronal to the CEJ were scored as a negative number.
Secondary Outcomes
- Gingival Index(6 months)
- Plaque Index(6 months)
- Bleeding on Probing(6 months)
- Mobility Index(6 months)