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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| beta-tricalcium phosphate alone | Active Comparator | beta-tricalcium phosphate alone |
|
| GFeBGS 0.1% | Experimental | GFeBGS consisting of beta-tricalcium phosphate + 0.1% recombinant human basic fibroblast growth factor (rh-bFGF) |
|
| GFeBGS 0.3% | Experimental | GFeBGS consisting of beta-tricalcium phosphate + 0.3% rh-bFGF |
|
| GFeGBS 0.4% | Experimental | GFeBGS consisting of beta-tricalcium phosphate + 0.4% rh-bFGF |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| beta-tricalcium phosphate alone | Device |
| ||
| GFeBGS 0.1% |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Baseline and 3 months post-surgery |
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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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David L. Cochran, DDS, PhD | University of Texas Health Sciences Center at San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Regenerative Solutions |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26908630 | Derived | 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. |
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Participants were recruited and enrolled at 6 dental clinical centers between November 2012 and December 2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | Beta-tricalcium Phosphate Alone | beta-tricalcium phosphate + placebo vehicle |
| FG001 | GFeBGS 0.1% | GFeBGS consisting of beta-tricalcium phosphate + 0.1% recombinant human basic fibroblast growth factor (rh-bFGF) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 20, 2013 | Aug 6, 2020 |
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| Device |
|
| GFeBGS 0.3% | Device |
|
| GFeBGS 0.4% | Device |
|
| 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) | Baseline and 6 months post-surgery |
| 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) | Baseline and 6 months post-surgery |
| 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. | Baseline and 6 months post-surgery |
| 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) | Baseline and 3 months post-surgery |
| 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) | Baseline and 6 months post-surgery |
| 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) | Baseline and 3 months post-surgery |
| 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) | Baseline and 6 months post-surgery |
| Fullerton |
| California |
| 92835 |
| United States |
| Drs. McClain and Schallhorn | Aurora | Colorado | 80012 | United States |
| University of Michigan | Ann Arbor | Michigan | 48106 | United States |
| Perio Health Professionals | Houston | Texas | 77063 | United States |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | United States |
| FG002 | GFeBGS 0.3% | GFeBGS consisting of beta-tricalcium phosphate + 0.3% rh-bFGF |
| FG003 | GFeGBS 0.4% | GFeBGS consisting of beta-tricalcium phosphate + 0.4% rh-bFGF |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Beta-tricalcium Phosphate Alone | beta-tricalcium phosphate + placebo vehicle |
| BG001 | GFeBGS 0.1% | GFeBGS consisting of beta-tricalcium phosphate + 0.1% recombinant human basic fibroblast growth factor (rh-bFGF) |
| BG002 | GFeBGS 0.3% | GFeBGS consisting of beta-tricalcium phosphate + 0.3% rh-bFGF |
| BG003 | GFeGBS 0.4% | GFeBGS consisting of beta-tricalcium phosphate + 0.4% rh-bFGF |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Smoking history | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The modified Intent-to-Treat population consisted of 83 subjects after two subjects were removed for lack of compliance with the study protocol. | Posted | Count of Participants | Participants | 6 months post-surgery |
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| Secondary | 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) | The modified Intent-to-Treat population consisted of 84 subjects after a subject was removed for lack of compliance with the study protocol. | Posted | Mean | Standard Deviation | mm | Baseline and 3 months post-surgery |
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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) | The modified Intent-to-Treat population consisted of 83 subjects after two subjects were removed for lack of compliance with the study protocol. | Posted | Mean | Standard Deviation | mm | Baseline and 6 months post-surgery |
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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) | The modified Intent-to-Treat population consisted of 83 subjects after two subjects were removed for lack of compliance with the study protocol. | Posted | Mean | Standard Deviation | mm | Baseline and 6 months post-surgery |
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The modified Intent-to-Treat population consisted of 83 subjects after two subjects were removed for lack of compliance with the study protocol. | Posted | Mean | Standard Deviation | percentage of bone height change | Baseline and 6 months post-surgery |
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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) | The modified Intent-to-Treat population consisted of 84 subjects after a subject was removed for lack of compliance with the study protocol. | Posted | Mean | Standard Deviation | mm | Baseline and 3 months post-surgery |
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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) | The modified Intent-to-Treat population consisted of 83 subjects after two subjects were removed for lack of compliance with the study protocol. | Posted | Mean | Standard Deviation | mm | Baseline and 6 months post-surgery |
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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) | The modified Intent-to-Treat population consisted of 84 subjects after a subject was removed for lack of compliance with the study protocol. | Posted | Mean | Standard Deviation | mm | Baseline and 3 months post-surgery |
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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) | The modified Intent-to-Treat population consisted of 83 subjects after two subjects were removed for lack of compliance with the study protocol. | Posted | Mean | Standard Deviation | mm | Baseline and 6 months post-surgery |
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| Post-Hoc | Number of Participants That Met the Success Criteria of Radiographic and Clinical Measurements (Updated Success Criteria) | 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 updated success criteria are ΔCAL ≥1.5 mm and LBG ≥ 2.5 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. | The modified Intent-to-Treat population consisted of 83 subjects after two subjects were removed for lack of compliance with the study protocol. | Posted | Count of Participants | Participants | 6 months post-surgery |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Beta-tricalcium Phosphate Alone | beta-tricalcium phosphate + placebo vehicle | 1 | 22 | 2 | 22 | 4 | 22 |
| EG001 | GFeBGS 0.1% | GFeBGS consisting of beta-tricalcium phosphate + 0.1% recombinant human basic fibroblast growth factor (rh-bFGF) | 0 | 21 | 1 | 21 | 6 | 21 |
| EG002 | GFeBGS 0.3% | GFeBGS consisting of beta-tricalcium phosphate + 0.3% rh-bFGF | 0 | 22 | 1 | 22 | 2 | 22 |
| EG003 | GFeGBS 0.4% | GFeBGS consisting of beta-tricalcium phosphate + 0.4% rh-bFGF | 0 | 23 | 0 | 23 | 10 | 23 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bunion | Blood and lymphatic system disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Basal cell carcinoma basal | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.1) | Non-systematic Assessment | Pre-existing condition was updated. |
|
| Chronic lymphocytic leukemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.1) | Non-systematic Assessment | Pre-existing condition was updated. |
|
| Coma | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment | An accident caused serious head trauma. |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application site pain | Injury, poisoning and procedural complications | MedDRA (17.1) | Non-systematic Assessment |
| |
| Application site inflammation | Injury, poisoning and procedural complications | MedDRA (17.1) | Non-systematic Assessment |
| |
| Application site hyperaesthesia | Injury, poisoning and procedural complications | MedDRA (17.1) | Non-systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
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Institution will submit the manuscript of the proposed publication to Sponsor at least 30 days prior to publication, and Sponsor shall have the right to review and comment upon the publication in order to protect Sponsor's confidential information. Upon Sponsor's written request, publication will be delayed up to 60 additional days to enable Sponsor to secure adequate intellectual property protection on Sponsor's intellectual property that would be affected by said publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Akane Takemura | Sunstar Americas, Inc. | 8477944276 | akane.takemura@us.sunstar.com |
| Prot_000.pdf |
| ID | Term |
|---|---|
| D016301 | Alveolar Bone Loss |
| D010510 | Periodontal Diseases |
| ID | Term |
|---|---|
| D001862 | Bone Resorption |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D055093 | Periodontal Atrophy |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Non-smoker |
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| Units | Counts |
|---|---|
| Participants |
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| Units | Counts |
|---|---|
| Participants |
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| Units | Counts |
|---|---|
| Participants |
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| Units | Counts |
|---|---|
| Participants |
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| OG002 | GFeBGS 0.3% | GFeBGS consisting of beta-tricalcium phosphate + 0.3% rh-bFGF |
| OG003 | GFeGBS 0.4% | GFeBGS consisting of beta-tricalcium phosphate + 0.4% rh-bFGF |
|
|