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

This study has been completed.

Study NCT00255970 Information provided by RTI Biologics

First Received on November 16, 2005. Last Updated on August 8, 2011 History of Changes

Results First Received: June 9, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Outcomes Assessor); Primary Purpose: Prevention
Condition:	Periodontal Diseases
Interventions:	Other: DFDBA Device: Regenafil

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment was done through the investigators clinics.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The was no wash out or run-in events in this study.

Reporting Groups

	Description
Regenafil	Regenafil graft
Demineralized Freeze Dried Bone Allograft	Demineralized Freeze Dried Bone Allograft (DFDBA)

Participant Flow: Overall Study

	Regenafil	Demineralized Freeze Dried Bone Allograft
STARTED	21	19
Screening Visit	21	19
Final Visit Week 24	21	19
COMPLETED	21	19
NOT COMPLETED	0	0

Baseline Characteristics

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Reporting Groups

	Description
Regenafil	Regenafil graft
Demineralized Freeze Dried Bone Allograft	Demineralized Freeze Dried Bone Allograft (DFDBA)

Baseline Measures

	Regenafil	Demineralized Freeze Dried Bone Allograft	Total
Number of Participants [units: participants]	21	19	40
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	17	17	34
>=65 years	4	2	6
Age [units: years] Mean ± Standard Deviation	51.7 ± 10.7	51.4 ± 14	51.6 ± 12.3
Gender [units: participants]
Female	7	11	18
Male	14	8	22
Region of Enrollment [units: participants]
United States	21	19	40

Outcome Measures

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1. Primary:

Change in Probing Depth [ Time Frame: baseline and then at 6 months ]

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2. Primary:

Clinical Attachment Level [ Time Frame: 6 months ]

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3. Primary:

Recession [ Time Frame: 6 months ]

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4. Secondary:

Gingival Index [ Time Frame: 6 months ]

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5. Secondary:

Plaque Index [ Time Frame: 6 months ]

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6. Secondary:

Bleeding on Probing [ Time Frame: 6 months ]

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7. Secondary:

Mobility Index [ Time Frame: 6 months ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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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.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Clinical Projects, Director
Organization: RTI Biologics
phone: 386-418-8888
e-mail: rparkhurst@rtix.com

No publications provided

Responsible Party:	Sponsor, Regeneration Technologies, Inc
ClinicalTrials.gov Identifier:	NCT00255970 History of Changes
Other Study ID Numbers:	RegenF052005
Study First Received:	November 16, 2005
Results First Received:	June 9, 2009
Last Updated:	August 8, 2011
Health Authority:	United States: Food and Drug Administration