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

• 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: RTI Surgical
• 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

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.

Arm/Group Title	Regenafil	Demineralized Freeze Dried Bone Allograft
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

Baseline Characteristics

Arm/Group Title		Regenafil	Demineralized Freeze Dried Bone Allograft	Total
Arm/Group Description		Regenafil graft	Demineralized Freeze Dried Bone Allograft (DFDBA)	Total of all reporting groups
Overall Number of Baseline Participants		21	19	40
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

Outcome Measures

1. Primary Outcome

Title	Change in Probing Depth
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Regenafil	Demineralized Freeze Dried Bone Allograft
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)

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]

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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Regenafil	Demineralized Freeze Dried Bone Allograft
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)

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
Description	CEJ to gingival margin (GM). GM coronal to the CEJ were scored as a negative number.
Time Frame	6 months

Outcome Measure Data

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
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)

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
Description	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.
Time Frame	6 months

Outcome Measure Data

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
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)

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
Description	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.
Time Frame	6 months

Outcome Measure Data

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
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)

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
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

Outcome Measure Data

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
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
Description	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.
Time Frame	6 months

Outcome Measure Data

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
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)

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Regenafil	Demineralized Freeze Dried Bone Allograft
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	--/--	--/--
Serious Adverse Events
	Regenafil	Demineralized Freeze Dried Bone Allograft
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/21 (0.00%)	0/19 (0.00%)
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%)

Limitations and Caveats

[Not Specified]

More Information

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

• Name/Title: Clinical Projects, Director
• Organization: RTI Biologics
• Phone: 386-418-8888
• EMail: rparkhurst@rtix.com

• 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