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GUIDOR® Growth Factor Enhanced Bone Graft Substitute for the Treatment of Periodontal Defects 6-months Post-Surgery

Primary Purpose

Alveolar Bone Loss, Periodontal Diseases

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
beta-tricalcium phosphate alone
GFeBGS 0.1%
GFeBGS 0.3%
GFeBGS 0.4%
Sponsored by
Sunstar Americas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alveolar Bone Loss focused on measuring bone grafting, alveolar bone loss, periodontal diseases

Eligibility Criteria

25 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female, age of 25 and older
  • Must have read, understood, and signed a consent form
  • Must be able and willing to follow study procedures and instructions
  • Must have undergone thorough scaling and root planing of the target tooth and be expected to demonstrate good plaque control after instruction in oral hygiene

  • The target tooth must exhibit the following:

    • A pocket depth of 7 mm or greater
    • After surgical debridement, 4 mm or greater intrabony defect with at least 1 bony wall
    • Sufficient keratinized tissue to allow complete tissue coverage of the defect
    • Radiographic base of defect at least 3 mm coronal to the apex of the tooth

Exclusion Criteria:

  • Failure to maintain adequate oral hygiene during the screening phase
  • Women of child-bearing potential
  • A history within the last 6 months of HIV, Type IV heart disease, or end-stage renal disease
  • A history of oral cancer or any other cancer (exception: subjects with a history of skin cancers such as squamous and basal carcinoma with end of treatment at least 6 months ago and/or prostate cancer with end of treatment at least 5 years ago may be enrolled)
  • A history within 12 months of previous open flap periodontal surgery on the study tooth.
  • A diagnosis of pre-malignant oral lesion(s)
  • A traumatic occlusion of the target tooth
  • Target "study" tooth exhibiting Grade III mobility
  • Maxillary molars or maxillary first premolar with a prominent mesial concavity
  • Study tooth exhibiting a Class II or greater furcation defect
  • Clinical or radiographic signs of untreated acute or chronic periapical infection at the surgical site, apical pathology, root fracture, severe root irregularities, cemental pearls, cervical enamel projections not easily removed by odontoplasty, untreated carious lesions at the cemento-enamel junction (CEJ) or on the root surface, or restorations with open or otherwise defective margins at or below the CEJ
  • A history within the last 6 months of the daily use of any tobacco products besides cigarettes (smokeless chewing tobacco, pipe or cigar smoking), or of smoking more than 10 cigarettes per day
  • Subjects participating in other clinical trials within 30 days of enrollment
  • Subjects having uncontrolled endocrine-induced diseases (e.g. uncontrolled diabetes mellitus and hyperparathyroidism)
  • Subjects undergoing current therapy with systemic steroids or other drugs that significantly alter bone metabolism
  • Subjects with Localized Juvenile Periodontitis (LJP) sites in the oral cavity

Sites / Locations

  • University of Alabama at Birmingham
  • Regenerative Solutions
  • Drs. McClain and Schallhorn
  • University of Michigan
  • Perio Health Professionals
  • University of Texas Health Science Center at San Antonio

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

beta-tricalcium phosphate alone

GFeBGS 0.1%

GFeBGS 0.3%

GFeGBS 0.4%

Arm Description

beta-tricalcium phosphate alone

GFeBGS consisting of beta-tricalcium phosphate + 0.1% recombinant human basic fibroblast growth factor (rh-bFGF)

GFeBGS consisting of beta-tricalcium phosphate + 0.3% rh-bFGF

GFeBGS consisting of beta-tricalcium phosphate + 0.4% rh-bFGF

Outcomes

Primary Outcome Measures

Number of Participants That Met the Success Criteria of Radiographic and Clinical Measurements
The primary effectiveness endpoint is a composite endpoint that considers radiographic and clinical measurements at six months post-implantation: the amount of linear bone growth (LBG), which is assessed with the use of radiographs, and the regain from baseline of clinical attachment level (∆CAL), which is assessed clinically. Linear bone growth (LBG) in a vertical and horizontal direction is determined radiographically at six months post-implantation. The clinical attachment level (CAL) is the distance from the cemento-enamel junction (CEJ) (or other fixed reference point) generally along the long axis of the tooth to the deepest extent of the periodontal pocket. The success criteria are ΔCAL ≥1.5 mm and LBG ≥1 mm at 6 months after the treatment. Both the ∆CAL and LBG must meet the success criteria for a subject to be considered a success.

Secondary Outcome Measures

Change in Clinical Attachment Level at 3 Months
The clinical attachment level is the distance from the cemento-enamel junction (or other fixed reference point) generally along the long axis of the tooth to the deepest extent of the periodontal pocket. Change = (3 months measurement - Baseline measurement)
Change in Clinical Attachment Level at 6 Months
The clinical attachment level is the distance from the cemento-enamel junction (or other fixed reference point) generally along the long axis of the tooth to the deepest extent of the periodontal pocket. Change = (6 months measurement - Baseline measurement)
Linear Bone Growth at 6 Months
Linear measurement of bone height in millimeters along mesial and/or distal root surfaces of the defect site is captured radiographically at baseline and 6 months. Linear Bone Growth = (Baseline measurement - 6 months measurement)
Percent Bone Fill at 6 Months
Linear measurement of bone height in millimeters along mesial and/or distal root surfaces of the defect site is captured radiographically at baseline and 6 months. Percent Bone Fill is calculated by dividing Linear Bone Growth at 6 months by bone height at baseline.
Pocket Depth Change at 3 Months
Length from free gingival margin to the base of the pocket in millimeter is measured with North Carolina 15 mm periodontal probes. Pocket Depth Change = (3 months measurement - Baseline measurement)
Pocket Depth Change at 6 Months
Length from free gingival margin to the base of the pocket in millimeter is measured with North Carolina 15 mm periodontal probes. Pocket Depth Change = (6 months measurement - Baseline measurement)
Change in Gingival Recession at 3 Months
Length from the free gingival margin to the CEJ is measured in millimeter with North Carolina 15 mm periodontal probes. Gingival Recession = (3 months measurement - Baseline measurement)
Change in Gingival Recession at 6 Months
Length from the free gingival margin to the CEJ is measured in millimeter with North Carolina 15 mm periodontal probes. Gingival Recession = (6 months measurement - Baseline measurement)

Full Information

First Posted
November 1, 2012
Last Updated
August 27, 2020
Sponsor
Sunstar Americas
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1. Study Identification

Unique Protocol Identification Number
NCT01728844
Brief Title
GUIDOR® Growth Factor Enhanced Bone Graft Substitute for the Treatment of Periodontal Defects 6-months Post-Surgery
Official Title
A Randomized, Double-Blind, Controlled, Multicenter Dose Verification Clinical Trial to Evaluate the Safety and Effectiveness of GUIDOR® Growth Factor Enhanced Bone Graft Substitute for the Treatment of Periodontal Defects 6-months Post-Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunstar Americas

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
GUIDOR Growth Factor Enchanted Bone Graft Substitute (GFeBGS) when used in periodontal surgery will shown greater gum and bone regeneration when compare to bone graft substitute alone. Also, to find the optimal dose.
Detailed Description
This will be a prospective, randomized, double-blinded, controlled, multi-center, dose-verification clinical study in subjects who require surgical intervention to treat a qualifying periodontal defect. Subjects 25 years and older with advanced periodontal disease in at least one site requiring surgical treatment to correct a bone defect.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alveolar Bone Loss, Periodontal Diseases
Keywords
bone grafting, alveolar bone loss, periodontal diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
beta-tricalcium phosphate alone
Arm Type
Active Comparator
Arm Description
beta-tricalcium phosphate alone
Arm Title
GFeBGS 0.1%
Arm Type
Experimental
Arm Description
GFeBGS consisting of beta-tricalcium phosphate + 0.1% recombinant human basic fibroblast growth factor (rh-bFGF)
Arm Title
GFeBGS 0.3%
Arm Type
Experimental
Arm Description
GFeBGS consisting of beta-tricalcium phosphate + 0.3% rh-bFGF
Arm Title
GFeGBS 0.4%
Arm Type
Experimental
Arm Description
GFeBGS consisting of beta-tricalcium phosphate + 0.4% rh-bFGF
Intervention Type
Device
Intervention Name(s)
beta-tricalcium phosphate alone
Intervention Type
Device
Intervention Name(s)
GFeBGS 0.1%
Intervention Type
Device
Intervention Name(s)
GFeBGS 0.3%
Intervention Type
Device
Intervention Name(s)
GFeBGS 0.4%
Primary Outcome Measure Information:
Title
Number of Participants That Met the Success Criteria of Radiographic and Clinical Measurements
Description
The primary effectiveness endpoint is a composite endpoint that considers radiographic and clinical measurements at six months post-implantation: the amount of linear bone growth (LBG), which is assessed with the use of radiographs, and the regain from baseline of clinical attachment level (∆CAL), which is assessed clinically. Linear bone growth (LBG) in a vertical and horizontal direction is determined radiographically at six months post-implantation. The clinical attachment level (CAL) is the distance from the cemento-enamel junction (CEJ) (or other fixed reference point) generally along the long axis of the tooth to the deepest extent of the periodontal pocket. The success criteria are ΔCAL ≥1.5 mm and LBG ≥1 mm at 6 months after the treatment. Both the ∆CAL and LBG must meet the success criteria for a subject to be considered a success.
Time Frame
6 months post-surgery
Secondary Outcome Measure Information:
Title
Change in Clinical Attachment Level at 3 Months
Description
The clinical attachment level is the distance from the cemento-enamel junction (or other fixed reference point) generally along the long axis of the tooth to the deepest extent of the periodontal pocket. Change = (3 months measurement - Baseline measurement)
Time Frame
Baseline and 3 months post-surgery
Title
Change in Clinical Attachment Level at 6 Months
Description
The clinical attachment level is the distance from the cemento-enamel junction (or other fixed reference point) generally along the long axis of the tooth to the deepest extent of the periodontal pocket. Change = (6 months measurement - Baseline measurement)
Time Frame
Baseline and 6 months post-surgery
Title
Linear Bone Growth at 6 Months
Description
Linear measurement of bone height in millimeters along mesial and/or distal root surfaces of the defect site is captured radiographically at baseline and 6 months. Linear Bone Growth = (Baseline measurement - 6 months measurement)
Time Frame
Baseline and 6 months post-surgery
Title
Percent Bone Fill at 6 Months
Description
Linear measurement of bone height in millimeters along mesial and/or distal root surfaces of the defect site is captured radiographically at baseline and 6 months. Percent Bone Fill is calculated by dividing Linear Bone Growth at 6 months by bone height at baseline.
Time Frame
Baseline and 6 months post-surgery
Title
Pocket Depth Change at 3 Months
Description
Length from free gingival margin to the base of the pocket in millimeter is measured with North Carolina 15 mm periodontal probes. Pocket Depth Change = (3 months measurement - Baseline measurement)
Time Frame
Baseline and 3 months post-surgery
Title
Pocket Depth Change at 6 Months
Description
Length from free gingival margin to the base of the pocket in millimeter is measured with North Carolina 15 mm periodontal probes. Pocket Depth Change = (6 months measurement - Baseline measurement)
Time Frame
Baseline and 6 months post-surgery
Title
Change in Gingival Recession at 3 Months
Description
Length from the free gingival margin to the CEJ is measured in millimeter with North Carolina 15 mm periodontal probes. Gingival Recession = (3 months measurement - Baseline measurement)
Time Frame
Baseline and 3 months post-surgery
Title
Change in Gingival Recession at 6 Months
Description
Length from the free gingival margin to the CEJ is measured in millimeter with North Carolina 15 mm periodontal probes. Gingival Recession = (6 months measurement - Baseline measurement)
Time Frame
Baseline and 6 months post-surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female, age of 25 and older Must have read, understood, and signed a consent form Must be able and willing to follow study procedures and instructions Must have undergone thorough scaling and root planing of the target tooth and be expected to demonstrate good plaque control after instruction in oral hygiene The target tooth must exhibit the following: A pocket depth of 7 mm or greater After surgical debridement, 4 mm or greater intrabony defect with at least 1 bony wall Sufficient keratinized tissue to allow complete tissue coverage of the defect Radiographic base of defect at least 3 mm coronal to the apex of the tooth Exclusion Criteria: Failure to maintain adequate oral hygiene during the screening phase Women of child-bearing potential A history within the last 6 months of HIV, Type IV heart disease, or end-stage renal disease A history of oral cancer or any other cancer (exception: subjects with a history of skin cancers such as squamous and basal carcinoma with end of treatment at least 6 months ago and/or prostate cancer with end of treatment at least 5 years ago may be enrolled) A history within 12 months of previous open flap periodontal surgery on the study tooth. A diagnosis of pre-malignant oral lesion(s) A traumatic occlusion of the target tooth Target "study" tooth exhibiting Grade III mobility Maxillary molars or maxillary first premolar with a prominent mesial concavity Study tooth exhibiting a Class II or greater furcation defect Clinical or radiographic signs of untreated acute or chronic periapical infection at the surgical site, apical pathology, root fracture, severe root irregularities, cemental pearls, cervical enamel projections not easily removed by odontoplasty, untreated carious lesions at the cemento-enamel junction (CEJ) or on the root surface, or restorations with open or otherwise defective margins at or below the CEJ A history within the last 6 months of the daily use of any tobacco products besides cigarettes (smokeless chewing tobacco, pipe or cigar smoking), or of smoking more than 10 cigarettes per day Subjects participating in other clinical trials within 30 days of enrollment Subjects having uncontrolled endocrine-induced diseases (e.g. uncontrolled diabetes mellitus and hyperparathyroidism) Subjects undergoing current therapy with systemic steroids or other drugs that significantly alter bone metabolism Subjects with Localized Juvenile Periodontitis (LJP) sites in the oral cavity
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David L. Cochran, DDS, PhD
Organizational Affiliation
University of Texas Health Sciences Center at San Antonio
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Regenerative Solutions
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Drs. McClain and Schallhorn
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
Perio Health Professionals
City
Houston
State/Province
Texas
ZIP/Postal Code
77063
Country
United States
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26908630
Citation
Cochran DL, Oh TJ, Mills MP, Clem DS, McClain PK, Schallhorn RA, McGuire MK, Scheyer ET, Giannobile WV, Reddy MS, Abou-Arraj RV, Vassilopoulos PJ, Genco RJ, Geurs NC, Takemura A. A Randomized Clinical Trial Evaluating rh-FGF-2/beta-TCP in Periodontal Defects. J Dent Res. 2016 May;95(5):523-30. doi: 10.1177/0022034516632497. Epub 2016 Feb 23.
Results Reference
derived

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GUIDOR® Growth Factor Enhanced Bone Graft Substitute for the Treatment of Periodontal Defects 6-months Post-Surgery

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