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

Regenerative Therapy for Vertical Defects Comparing Demineralized Freeze Dried Bone Allograft (DFDBA) and Regenafil

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.

Study Overview

• Status: Completed
• Conditions: Periodontal Diseases
• Intervention / Treatment: Device: Regenafil; Other: DFDBA

Detailed Description

To compare the regenerative effects of a demineralized freeze dried bone allograft (DFDBA) particulate in a biologic thermoplastic carrier (Regenafil) to the standard of care. To compare the regenerative effects of a demineralized freeze dried bone allograft (DFDBA) particulate in the treatment of intraosseous vertical defects following six months of healing. This was accomplished by evaluating clinical parameters including probing depth, attachment level and bleeding upon probing, using attachment level as the primary outcome variable.

Treatment of the vertical osseous defect is a challenging problem in periodontics. There are many treatment options including:

1. open flap debridement;
2. osseous graft alone;
3. membrane alone;
4. or membrane plus an osseous graft.

Choice of treatment may depend on the defect depth and configuration. A shallow, narrow 3 wall defect may respond well to open flap debridement while a deep 2 wall defect may need regenerative therapy such as an osseous graft, a membrane or combined membrane and graft treatment. Studies of vertical defect therapy with defects about 4 mm or greater show that similar percent defect fill results are obtained with regenerative therapies. Open flap debridement produces substantially less percent defect fill.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University School of Dentistry
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville School of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Have debilitating systemic diseases, or diseases that affect the periodontium.

2. 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
3. Need prophylactic antibiotics.
4. Have a vertical osseous defect that is related to a furcation area.
5. Smoke more than 1 pack per day.
6. Have endodontically treated teeth or endodontic lesions at study sites.
7. Have 1-wall defects.
8. Have poor oral hygiene.
9. 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.)
10. Be pregnant as evidenced by a positive urine pregnancy test taken at both the screening and baseline visits.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Regenafil graft; Regenafil	Device: Regenafil; Demineralized Freeze Dried Bone in a porcine gel carrier; Other Names: Demineralized Freeze Dried Bone Allograft
ACTIVE_COMPARATOR: DFDBA; Demineralized Freeze Dried Bone Allograft	Device: Regenafil; Demineralized Freeze Dried Bone in a porcine gel carrier; Other Names: Demineralized Freeze Dried Bone Allograft; Other: DFDBA; Demineralized Freeze Dried Allograft bone; Other Names: Demineralized Bone Matrix

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gingival Index	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.	6 months
Plaque Index	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.	6 months
Bleeding on Probing	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.	6 months
Mobility Index	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.	6 months

Collaborators and Investigators

• Sponsor: RTI Surgical
• Investigators: Principal Investigator: Steven Blanchard, DDS, Indiana University

Study record dates

Study Major Dates

• Study Start: January 1, 2006
• Primary Completion (ACTUAL): November 1, 2007
• Study Completion (ACTUAL): November 1, 2007

Study Registration Dates

• First Submitted: November 16, 2005
• First Submitted That Met QC Criteria: November 16, 2005
• First Posted (ESTIMATE): November 21, 2005

Study Record Updates

• Last Update Posted (ESTIMATE): August 10, 2011
• Last Update Submitted That Met QC Criteria: August 8, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Keywords: Periodontal Treatment of Intraosseous Vertical Defects
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Periodontal Diseases
• Other Study ID Numbers: RegenF052005