NCT00255970

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2006

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 21, 2005

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2006

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
3.8 years until next milestone

Results Posted

Study results publicly available

August 5, 2011

Completed
Last Updated

August 10, 2011

Status Verified

August 1, 2011

Enrollment Period

1.8 years

First QC Date

November 16, 2005

Results QC Date

June 9, 2009

Last Update Submit

August 8, 2011

Conditions

Periodontal Diseases

Keywords

Periodontal Treatment of Intraosseous Vertical Defects

Outcome Measures

Primary Outcomes (3)

  • 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.

    baseline and then at 6 months

  • 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.

    6 months

  • Recession

    CEJ to gingival margin (GM). GM coronal to the CEJ were scored as a negative number.

    6 months

Secondary Outcomes (4)

  • Gingival Index

    6 months

  • Plaque Index

    6 months

  • Bleeding on Probing

    6 months

  • Mobility Index

    6 months

Study Arms (2)

Regenafil graft

EXPERIMENTAL

Regenafil

Device: Regenafil

DFDBA

ACTIVE COMPARATOR

Demineralized Freeze Dried Bone Allograft

Other: DFDBADevice: Regenafil

Interventions

DFDBAOTHER

Demineralized Freeze Dried Allograft bone

Also known as: Demineralized Bone Matrix
DFDBA
RegenafilDEVICE

Demineralized Freeze Dried Bone in a porcine gel carrier

Also known as: Demineralized Freeze Dried Bone Allograft
DFDBARegenafil graft

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Provide written informed consent prior to their participation.
  • Be an adult age 18 and older.
  • 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.
  • Have osseous defects that are either wide 3-wall, or combination defects.

You may not qualify if:

  • Have debilitating systemic diseases, or diseases that affect the periodontium.
  • 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
  • Need prophylactic antibiotics.
  • Have a vertical osseous defect that is related to a furcation area.
  • Smoke more than 1 pack per day.
  • Have endodontically treated teeth or endodontic lesions at study sites.
  • Have 1-wall defects.
  • Have poor oral hygiene.
  • 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.)
  • Be pregnant as evidenced by a positive urine pregnancy test taken at both the screening and baseline visits.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Indiana University School of Dentistry

Indianapolis, Indiana, 46202, United States

Location

University of Louisville School of Dentistry

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Periodontal Diseases

Interventions

Grafton demineralized bone matrix gel

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Results Point of Contact

Title
Clinical Projects, Director
Organization
RTI Biologics
rparkhurst@rtix.com
386-418-8888

Study Officials

  • Henry Greenwell, DMD

    University of Louisville

    PRINCIPAL INVESTIGATOR

  • Steven Blanchard, DDS

    Indiana University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 16, 2005

First Posted

November 21, 2005

Study Start

January 1, 2006

Primary Completion

November 1, 2007

Study Completion

November 1, 2007

Last Updated

August 10, 2011

Results First Posted

August 5, 2011

Record last verified: 2011-08

Locations

US(2)