Trial Outcomes & Findings for Regenafil Versus Demineralized Freeze Dried Bone Allograft (DFDBA) for Periodontal Defects (NCT NCT00255970)
NCT ID: NCT00255970
Last Updated: 2011-08-10
Results Overview
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.
COMPLETED
PHASE2/PHASE3
40 participants
baseline and then at 6 months
2011-08-10
Participant Flow
Recruitment was done through the investigators clinics.
The was no wash out or run-in events in this study.
Participant milestones
| Measure |
Regenafil
Regenafil graft
|
Demineralized Freeze Dried Bone Allograft
Demineralized Freeze Dried Bone Allograft (DFDBA)
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
19
|
|
Overall Study
Screening Visit
|
21
|
19
|
|
Overall Study
Final Visit Week 24
|
21
|
19
|
|
Overall Study
COMPLETED
|
21
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Regenafil Versus Demineralized Freeze Dried Bone Allograft (DFDBA) for Periodontal Defects
Baseline characteristics by cohort
| Measure |
Regenafil
n=21 Participants
Regenafil graft
|
Demineralized Freeze Dried Bone Allograft
n=19 Participants
Demineralized Freeze Dried Bone Allograft (DFDBA)
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
34 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Age Continuous
|
51.7 years
STANDARD_DEVIATION 10.7 • n=93 Participants
|
51.4 years
STANDARD_DEVIATION 14 • n=4 Participants
|
51.6 years
STANDARD_DEVIATION 12.3 • n=27 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=93 Participants
|
19 participants
n=4 Participants
|
40 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: baseline and then at 6 monthsThis 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.
Outcome measures
| Measure |
Regenafil
n=21 Participants
Regenafil graft
|
Demineralized Freeze Dried Bone Allograft
n=19 Participants
Demineralized Freeze Dried Bone Allograft (DFDBA)
|
|---|---|---|
|
Change in Probing Depth
|
2.7 mm
Standard Deviation 1.1
|
2.4 mm
Standard Deviation 1.2
|
PRIMARY outcome
Timeframe: 6 monthsThe 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.
Outcome measures
| Measure |
Regenafil
n=21 Participants
Regenafil graft
|
Demineralized Freeze Dried Bone Allograft
n=19 Participants
Demineralized Freeze Dried Bone Allograft (DFDBA)
|
|---|---|---|
|
Clinical Attachment Level
|
5.6 mm
Standard Deviation 2.0
|
6.3 mm
Standard Deviation 1.9
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: 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
CEJ to gingival margin (GM). GM coronal to the CEJ were scored as a negative number.
Outcome measures
| Measure |
Regenafil
n=21 Participants
Regenafil graft
|
Demineralized Freeze Dried Bone Allograft
n=19 Participants
Demineralized Freeze Dried Bone Allograft (DFDBA)
|
|---|---|---|
|
Recession
|
0.9 mm
Standard Deviation 1.1
|
0.9 mm
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: As stated in the protocol, the power analysis (threshold=0.05, power\>0.8) noted 18 subjects would be needed per group.
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.
Outcome measures
| Measure |
Regenafil
n=21 Participants
Regenafil graft
|
Demineralized Freeze Dried Bone Allograft
n=19 Participants
Demineralized Freeze Dried Bone Allograft (DFDBA)
|
|---|---|---|
|
Gingival Index
|
0.5 Units on a scale
Standard Deviation 0.8
|
0.7 Units on a scale
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 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
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.
Outcome measures
| Measure |
Regenafil
n=21 Participants
Regenafil graft
|
Demineralized Freeze Dried Bone Allograft
n=19 Participants
Demineralized Freeze Dried Bone Allograft (DFDBA)
|
|---|---|---|
|
Plaque Index
|
0.4 Categorical index score
Standard Deviation 0.5
|
0.6 Categorical index score
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 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).
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.
Outcome measures
| Measure |
Regenafil
n=21 Participants
Regenafil graft
|
Demineralized Freeze Dried Bone Allograft
n=19 Participants
Demineralized Freeze Dried Bone Allograft (DFDBA)
|
|---|---|---|
|
Bleeding on Probing
|
0.4 Units on a scale
Standard Deviation 0.3
|
0.3 Units on a scale
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Regenafil
n=21 Participants
Regenafil graft
|
Demineralized Freeze Dried Bone Allograft
n=19 Participants
Demineralized Freeze Dried Bone Allograft (DFDBA)
|
|---|---|---|
|
Mobility Index
|
0.4 Units on a scale
Standard Deviation 0.5
|
0.6 Units on a scale
Standard Deviation 0.5
|
Adverse Events
Regenafil
Demineralized Freeze Dried Bone Allograft
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60