Periodontal Diseases
Conditions
Keywords
Periodontal Treatment of Intraosseous Vertical Defects
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.
Interventions
OTHERDFDBA
Demineralized Freeze Dried Allograft bone
DEVICERegenafil
Demineralized Freeze Dried Bone in a porcine gel carrier
Sponsors
RTI Surgical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Probing Depth | 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 | 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 | 6 months | CEJ to gingival margin (GM). GM coronal to the CEJ were scored as a negative number. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gingival Index | 6 months | Scores: 0 Normal gingiva 1. Mild inflammation 2. Moderate inflammation 3. 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. |
| Mobility Index | 6 months | Tooth mobility was recorded using Miller's Index: 1. \- up to 1 mm of movement in a horizontal direction 2. \- greater than 1 mm of movement in a horizontal direction 3. \- 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. |
| Plaque Index | 6 months | 0- No plaque 1. A film of plaque adhering to gingival margin & adjacent area of tooth 2. Moderate accumulation of soft deposits, visible with the naked eye 3. 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. |
| Bleeding on Probing | 6 months | 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. |
Countries
United States
Participant flow
Recruitment details
Recruitment was done through the investigators clinics.
Pre-assignment details
The was no wash out or run-in events in this study.
Participants by arm
| Arm | Count |
|---|---|
| Regenafil Regenafil graft | 21 |
| Demineralized Freeze Dried Bone Allograft Demineralized Freeze Dried Bone Allograft (DFDBA) | 19 |
| Total | 40 |
Baseline characteristics
| Characteristic | Demineralized Freeze Dried Bone Allograft | Regenafil | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 4 Participants | 6 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants | 17 Participants | 34 Participants |
| Age Continuous | 51.4 years STANDARD_DEVIATION 14 | 51.7 years STANDARD_DEVIATION 10.7 | 51.6 years STANDARD_DEVIATION 12.3 |
| Region of Enrollment United States | 19 participants | 21 participants | 40 participants |
| Sex: Female, Male Female | 11 Participants | 7 Participants | 18 Participants |
| Sex: Female, Male Male | 8 Participants | 14 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 21 | 0 / 19 |
| serious Total, serious adverse events | 0 / 21 | 0 / 19 |
Outcome results
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.
Time frame: baseline and then at 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Regenafil | Change in Probing Depth | 2.7 mm | Standard Deviation 1.1 |
| Demineralized Freeze Dried Bone Allograft | Change in Probing Depth | 2.4 mm | Standard Deviation 1.2 |
Comparison: This study had been designed as a superiority study. The null hypothesis had been that there would be no significant difference in probing depth between groups at the time points measured.p-value: >0.05ANOVA
Comparison: A power analysis, prior to data collection, determined that a minimum of 18 in each arm would be needed for this study.p-value: >0.05ANOVA
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Regenafil | Clinical Attachment Level | 5.6 mm | Standard Deviation 2 |
| Demineralized Freeze Dried Bone Allograft | Clinical Attachment Level | 6.3 mm | Standard Deviation 1.9 |
Comparison: This study had been designed as a superiority study. 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).p-value: >0.05ANOVA
Primary
Recession
CEJ to gingival margin (GM). GM coronal to the CEJ were scored as a negative number.
Time frame: 6 months
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Regenafil | Recession | 0.9 mm | Standard Deviation 1.1 |
| Demineralized Freeze Dried Bone Allograft | Recession | 0.9 mm | Standard Deviation 1.1 |
Comparison: The change in recession, measured in mm, had been designed as a superiority study. 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).p-value: >0.05ANOVA
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.
Time frame: 6 months
Population: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Regenafil | Bleeding on Probing | 0.4 Units on a scale | Standard Deviation 0.3 |
| Demineralized Freeze Dried Bone Allograft | Bleeding on Probing | 0.3 Units on a scale | Standard Deviation 0.3 |
Secondary
Gingival Index
Scores: 0 Normal gingiva 1. Mild inflammation 2. Moderate inflammation 3. 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.
Time frame: 6 months
Population: As stated in the protocol, the power analysis (threshold=0.05, power\>0.8) noted 18 subjects would be needed per group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Regenafil | Gingival Index | 0.5 Units on a scale | Standard Deviation 0.8 |
| Demineralized Freeze Dried Bone Allograft | Gingival Index | 0.7 Units on a scale | Standard Deviation 0.8 |
Comparison: Each gingival unit (buccal, lingual, mesiobuccal, distobuccal, mesiolingual, and distolingual) of the individual tooth will be given a score from 0-3, called the gingival index for the area. The scores from the 6 areas of the tooth are added and divided by 6 to give the gingival index for the tooth.p-value: >0.05ANOVA
Secondary
Mobility Index
Tooth mobility was recorded using Miller's Index: 1. \- up to 1 mm of movement in a horizontal direction 2. \- greater than 1 mm of movement in a horizontal direction 3. \- 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.
Time frame: 6 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Regenafil | Mobility Index | 0.4 Units on a scale | Standard Deviation 0.5 |
| Demineralized Freeze Dried Bone Allograft | Mobility Index | 0.6 Units on a scale | Standard Deviation 0.5 |
Secondary
Plaque Index
0- No plaque 1. A film of plaque adhering to gingival margin & adjacent area of tooth 2. Moderate accumulation of soft deposits, visible with the naked eye 3. 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.
Time frame: 6 months
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Regenafil | Plaque Index | 0.4 Categorical index score | Standard Deviation 0.5 |
| Demineralized Freeze Dried Bone Allograft | Plaque Index | 0.6 Categorical index score | Standard Deviation 0.5 |
Comparison: This study had been designed as a superiority study. 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).p-value: >0.05ANOVA