Periodontal DiseasesPhase 2/3NCT00255970
Regenafil Versus Demineralized Freeze Dried Bone Allograft (DFDBA) for Periodontal Defects
A Phase 2/3 study testing DFDBA and Regenafil in people with Periodontal Diseases, run by RTI Surgical at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases
- What is being tested?
- DFDBA and Regenafil
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2006to Nov 2007
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
- gelatin
Show all 14Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Indiana University School of Dentistry
Indianapolis, Indiana, 46202
University of Louisville School of Dentistry
Louisville, Kentucky, 40202
About this study
Official title: Regenerative Therapy for Vertical Defects Comparing Demineralized Freeze Dried Bone Allograft (DFDBA) and Regenafil
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.
Read the 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:
- open flap debridement;
- osseous graft alone;
- membrane alone;
- 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
- Being tested
- DFDBA, Regenafil
- Keywords
- Periodontal Treatment of Intraosseous Vertical Defects
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DFDBAOther
Also called Demineralized Bone Matrix
Demineralized Freeze Dried Allograft bone
RegenafilDevice
Also called Demineralized Freeze Dried Bone Allograft
Demineralized Freeze Dried Bone in a porcine gel carrier
| Study group | Role | What they receive |
|---|---|---|
| Regenafil graft | Experimental | Regenafil Receives: Device: Regenafil |
| DFDBA | Active comparator | Demineralized Freeze Dried Bone Allograft Receives: Other: DFDBA; Device: Regenafil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 months
Recession
CEJ to gingival margin (GM). GM coronal to the CEJ were scored as a negative number.
Measured: 6 months
Secondary outcomes (4)
Gingival Index
Scores:
0 Normal gingiva
- Mild inflammation
- Moderate inflammation
- Severe inflammation Gingival units (buccal, lingual, mesiobuccal, distobuccal, mesiolingual, and distolingual) of each tooth were scored 0-3. Scores from the 6 areas of the tooth were added and divided by 6 to give the gingival index for the entire tooth.
Measured: 6 months
Plaque Index
0- No plaque
- A film of plaque adhering to gingival margin \& adjacent area of tooth
- Moderate accumulation of soft deposits, visible with the naked eye
- Abundance of soft matter Each gingival region of the individual tooth will be scored 0-3 The scores from the 6 areas of the tooth are averaged to give the plaque index for the tooth.
Measured: 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.
Measured: 6 months
Mobility Index
Tooth mobility was recorded using Miller's Index:
- - up to 1 mm of movement in a horizontal direction
- - greater than 1 mm of movement in a horizontal direction
- - excessive horizontal movement and vertical movement. Manual evaluation of mobility was carried out clinically using the handles of two instruments to move the teeth buccally and lingually and note their movement.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2005 (estimated)
- Study startJan 2006
- Primary completionNov 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- RTI Surgical
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Henry Greenwell, DMD, Principal investigator, University of LouisvilleSteven Blanchard, DDS, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00255970
- Sponsor's protocol ID
- RegenF052005
- Status last verified
- Aug 2011
- First submitted
- 16 Nov 2005
- Last updated
- 10 Aug 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regenerative Therapy for Vertical Defects Comparing Demineralized Freeze Dried Bone Allograft (DFDBA) and Regenafil
- ClinicalTrials.gov ID
- NCT00255970
- Acronym / sponsor ID
- RegenF052005
- Conditions
- Periodontal Diseases
- Keywords
- Periodontal Treatment of Intraosseous Vertical Defects
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- RTI SurgicalIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 21 Nov 2005 (estimated)
- Results
- Posted 5 Aug 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- open flap debridement;
- osseous graft alone;
- membrane alone;
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regenafil graft | Experimental | Device: RegenafilRegenafil |
| DFDBA | Active comparator | Other: DFDBA, Device: RegenafilDemineralized Freeze Dried Bone Allograft |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DFDBAAlso: Demineralized Bone MatrixDemineralized Freeze Dried Allograft bone | Other | DFDBA |
| RegenafilAlso: Demineralized Freeze Dried Bone AllograftDemineralized Freeze Dried Bone in a porcine gel carrier | Device | DFDBA, Regenafil graft |
Primary outcome
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.
4 secondary outcomes
Gingival Index
Time frame: 6 months
Plaque Index
Time frame: 6 months
Bleeding on Probing
Time frame: 6 months
Mobility Index
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henry Greenwell, DMD principal investigator
University of Louisville
Steven Blanchard, DDS principal investigator
Indiana University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing DFDBA and Regenafil in people with Periodontal Diseases, run by RTI Surgical at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Aug 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Probing Depth (time frame: baseline and then at 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2011; AzTrials last refreshed its copy on 8 Nov 2026.