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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regenafil graft | Experimental | Regenafil |
|
| DFDBA | Active Comparator | Demineralized Freeze Dried Bone Allograft |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DFDBA | Other | Demineralized Freeze Dried Allograft bone |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Probing Depth | 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. | baseline and then at 6 months |
| Clinical Attachment Level | 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. | 6 months |
| Recession | CEJ to gingival margin (GM). GM coronal to the CEJ were scored as a negative number. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Gingival Index | Scores: 0 Normal gingiva
| 6 months |
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Inclusion Criteria:
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:
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.
Have poor oral hygiene.
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.)
Be pregnant as evidenced by a positive urine pregnancy test taken at both the screening and baseline visits.
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| Name | Affiliation | Role |
|---|---|---|
| Henry Greenwell, DMD | University of Louisville | Principal Investigator |
| Steven Blanchard, DDS | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University School of Dentistry | Indianapolis | Indiana | 46202 | United States | ||
| University of Louisville School of Dentistry |
The was no wash out or run-in events in this study.
Recruitment was done through the investigators clinics.
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| ID | Title | Description |
|---|---|---|
| FG000 | Regenafil | Regenafil graft |
| FG001 | Demineralized Freeze Dried Bone Allograft | Demineralized Freeze Dried Bone Allograft (DFDBA) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Regenafil | Regenafil graft |
| BG001 | Demineralized Freeze Dried Bone Allograft | Demineralized Freeze Dried Bone Allograft (DFDBA) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Probing Depth | 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. | Posted | Jun 2009 | Mean | Standard Deviation | mm | baseline and then at 6 months |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Regenafil | Regenafil graft |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Projects, Director | RTI Biologics | 386-418-8888 | rparkhurst@rtix.com |
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| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| C497176 | Grafton demineralized bone matrix gel |
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| Regenafil | Device | Demineralized Freeze Dried Bone in a porcine gel carrier |
|
|
| Plaque Index | 0- No plaque
| 6 months |
| Bleeding on Probing | 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. | 6 months |
| Mobility Index | Tooth mobility was recorded using Miller's Index:
| 6 months |
| Louisville |
| Kentucky |
| 40202 |
| United States |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Counts |
|---|
| Participants |
|
|
|
| Primary | Clinical Attachment Level | 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. | Posted | Jun 2009 | Mean | Standard Deviation | mm | 6 months |
|
|
|
|
| Primary | Recession | CEJ to gingival margin (GM). GM coronal to the CEJ were scored as a negative number. | The number of participants to be analyzed was based on a power analysis, using a threshold of 0.05 with a power of 0.8. The power analysis indicated 18 participants were needed in each arm | Posted | Jun 2009 | Mean | Standard Deviation | mm | 6 months |
|
|
|
|
| Secondary | Gingival Index | Scores: 0 Normal gingiva
| As stated in the protocol, the power analysis (threshold=0.05, power>0.8) noted 18 subjects would be needed per group. | Posted | Jun 2009 | Mean | Standard Deviation | Units on a scale | 6 months |
|
|
|
|
| Secondary | Plaque Index | 0- No plaque
| The number of participants to be analyzed was based on a power analysis, using a threshold of 0.05 with a power of 0.8. The power analysis indicated 18 participants were needed in each arm | Posted | Jun 2009 | Mean | Standard Deviation | Categorical index score | 6 months |
|
|
|
|
| Secondary | Bleeding on Probing | 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. | The a priori power analysis had been designed with an effect size based on historical data. Thus, a minimal sample size of 34 patients would be necessary to determine if there was a true difference between groups, α =.05, power= 0.8. This number was then rounded to 40 patients, 20/ group (DFDBA and Regenafil). | Posted | Mean | Standard Deviation | Units on a scale | 6 months |
|
|
|
| Secondary | Mobility Index | Tooth mobility was recorded using Miller's Index:
| A power analysis, prior to data collection, determined that a minimum of 18 in each arm would be needed for this study. The power analysis had been computed for a threshold of 0.05 with a power of 0.8. | Posted | Mean | Standard Deviation | Units on a scale | 6 months |
|
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | Demineralized Freeze Dried Bone Allograft | Demineralized Freeze Dried Bone Allograft (DFDBA) | 0 | 19 | 0 | 19 |
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