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Regenafil Versus Demineralized Freeze Dried Bone Allograft (DFDBA) for Periodontal Defects

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ClinicalTrials.gov Identifier: NCT00255970
Recruitment Status : Completed
First Posted : November 21, 2005
Results First Posted : August 5, 2011
Last Update Posted : August 10, 2011
Sponsor:
Information provided by:
RTI Surgical

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Prevention
Condition Periodontal Diseases
Interventions Other: DFDBA
Device: Regenafil
Enrollment 40
Recruitment Details Recruitment was done through the investigators clinics.
Pre-assignment Details The was no wash out or run-in events in this study.
Arm/Group Title Regenafil Demineralized Freeze Dried Bone Allograft
Hide Arm/Group Description Regenafil graft Demineralized Freeze Dried Bone Allograft (DFDBA)
Period Title: Overall Study
Started 21 19
Screening Visit 21 19
Final Visit Week 24 21 19
Completed 21 19
Not Completed 0 0
Arm/Group Title Regenafil Demineralized Freeze Dried Bone Allograft Total
Hide Arm/Group Description Regenafil graft Demineralized Freeze Dried Bone Allograft (DFDBA) Total of all reporting groups
Overall Number of Baseline Participants 21 19 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 19 participants 40 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
17
  81.0%
17
  89.5%
34
  85.0%
>=65 years
4
  19.0%
2
  10.5%
6
  15.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 21 participants 19 participants 40 participants
51.7  (10.7) 51.4  (14) 51.6  (12.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 19 participants 40 participants
Female
7
  33.3%
11
  57.9%
18
  45.0%
Male
14
  66.7%
8
  42.1%
22
  55.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 21 participants 19 participants 40 participants
21 19 40
1.Primary Outcome
Title Change in Probing Depth
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Regenafil Demineralized Freeze Dried Bone Allograft
Hide Arm/Group Description:
Regenafil graft
Demineralized Freeze Dried Bone Allograft (DFDBA)
Overall Number of Participants Analyzed 21 19
Mean (Standard Deviation)
Unit of Measure: mm
2.7  (1.1) 2.4  (1.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Regenafil, Demineralized Freeze Dried Bone Allograft
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Regenafil, Demineralized Freeze Dried Bone Allograft
Comments A power analysis, prior to data collection, determined that a minimum of 18 in each arm would be needed for this study.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments The power analysis had been computed for a threshold of 0.05 with a power of 0.8.
Method ANOVA
Comments [Not Specified]
2.Primary Outcome
Title Clinical Attachment Level
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Regenafil Demineralized Freeze Dried Bone Allograft
Hide Arm/Group Description:
Regenafil graft
Demineralized Freeze Dried Bone Allograft (DFDBA)
Overall Number of Participants Analyzed 21 19
Mean (Standard Deviation)
Unit of Measure: mm
5.6  (2.0) 6.3  (1.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Regenafil, Demineralized Freeze Dried Bone Allograft
Comments 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).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
3.Primary Outcome
Title Recession
Hide Description CEJ to gingival margin (GM). GM coronal to the CEJ were scored as a negative number.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Regenafil Demineralized Freeze Dried Bone Allograft
Hide Arm/Group Description:
Regenafil graft
Demineralized Freeze Dried Bone Allograft (DFDBA)
Overall Number of Participants Analyzed 21 19
Mean (Standard Deviation)
Unit of Measure: mm
0.9  (1.1) 0.9  (1.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Regenafil, Demineralized Freeze Dried Bone Allograft
Comments 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).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
4.Secondary Outcome
Title Gingival Index
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
As stated in the protocol, the power analysis (threshold=0.05, power>0.8) noted 18 subjects would be needed per group.
Arm/Group Title Regenafil Demineralized Freeze Dried Bone Allograft
Hide Arm/Group Description:
Regenafil graft
Demineralized Freeze Dried Bone Allograft (DFDBA)
Overall Number of Participants Analyzed 21 19
Mean (Standard Deviation)
Unit of Measure: Units on a scale
0.5  (0.8) 0.7  (0.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Regenafil, Demineralized Freeze Dried Bone Allograft
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
5.Secondary Outcome
Title Plaque Index
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Regenafil Demineralized Freeze Dried Bone Allograft
Hide Arm/Group Description:
Regenafil graft
Demineralized Freeze Dried Bone Allograft (DFDBA)
Overall Number of Participants Analyzed 21 19
Mean (Standard Deviation)
Unit of Measure: Categorical index score
0.4  (0.5) 0.6  (0.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Regenafil, Demineralized Freeze Dried Bone Allograft
Comments 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).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
6.Secondary Outcome
Title Bleeding on Probing
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Regenafil Demineralized Freeze Dried Bone Allograft
Hide Arm/Group Description:
Regenafil graft
Demineralized Freeze Dried Bone Allograft (DFDBA)
Overall Number of Participants Analyzed 21 19
Mean (Standard Deviation)
Unit of Measure: Units on a scale
0.4  (0.3) 0.3  (0.3)
7.Secondary Outcome
Title Mobility Index
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Regenafil Demineralized Freeze Dried Bone Allograft
Hide Arm/Group Description:
Regenafil graft
Demineralized Freeze Dried Bone Allograft (DFDBA)
Overall Number of Participants Analyzed 21 19
Mean (Standard Deviation)
Unit of Measure: Units on a scale
0.4  (0.5) 0.6  (0.5)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Regenafil Demineralized Freeze Dried Bone Allograft
Hide Arm/Group Description Regenafil graft Demineralized Freeze Dried Bone Allograft (DFDBA)
All-Cause Mortality
Regenafil Demineralized Freeze Dried Bone Allograft
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Regenafil Demineralized Freeze Dried Bone Allograft
Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/19 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Regenafil Demineralized Freeze Dried Bone Allograft
Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/19 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Projects, Director
Organization: RTI Biologics
Phone: 386-418-8888
EMail: rparkhurst@rtix.com
Layout table for additonal information
Responsible Party: Sponsor, Regeneration Technologies, Inc
ClinicalTrials.gov Identifier: NCT00255970    
Other Study ID Numbers: RegenF052005
First Submitted: November 16, 2005
First Posted: November 21, 2005
Results First Submitted: June 9, 2009
Results First Posted: August 5, 2011
Last Update Posted: August 10, 2011