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

Periodontal Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00255970
• Other study ID #: RegenF052005
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: November 16, 2005
• Last updated: August 8, 2011
• Start date: January 2006
• Est. completion date: November 2007

Study information

• Verified date: August 2011
• Source: RTI Surgical
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Gingival Diseases
• Periodontal Diseases

Intervention

Other:
• DFDBA
Demineralized Freeze Dried Allograft bone

Device:
• Regenafil
Demineralized Freeze Dried Bone in a porcine gel carrier

Locations

Country	Name	City	State
United States	Indiana University School of Dentistry	Indianapolis	Indiana
United States	University of Louisville School of Dentistry	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
RTI Surgical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	Recession	CEJ to gingival margin (GM). GM coronal to the CEJ were scored as a negative number.	6 months	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No