Trial Outcomes & Findings for GUIDOR® Growth Factor Enhanced Bone Graft Substitute for the Treatment of Periodontal Defects 6-months Post-Surgery (NCT NCT01728844)
NCT ID: NCT01728844
Last Updated: 2020-09-17
Results Overview
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.
COMPLETED
NA
88 participants
6 months post-surgery
2020-09-17
Participant Flow
Participants were recruited and enrolled at 6 dental clinical centers between November 2012 and December 2013.
Participant milestones
| Measure |
Beta-tricalcium Phosphate Alone
beta-tricalcium phosphate + placebo vehicle
|
GFeBGS 0.1%
GFeBGS consisting of beta-tricalcium phosphate + 0.1% recombinant human basic fibroblast growth factor (rh-bFGF)
|
GFeBGS 0.3%
GFeBGS consisting of beta-tricalcium phosphate + 0.3% rh-bFGF
|
GFeGBS 0.4%
GFeBGS consisting of beta-tricalcium phosphate + 0.4% rh-bFGF
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
22
|
21
|
22
|
23
|
|
Overall Study
COMPLETED
|
21
|
21
|
22
|
21
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
GUIDOR® Growth Factor Enhanced Bone Graft Substitute for the Treatment of Periodontal Defects 6-months Post-Surgery
Baseline characteristics by cohort
| Measure |
Beta-tricalcium Phosphate Alone
n=22 Participants
beta-tricalcium phosphate + placebo vehicle
|
GFeBGS 0.1%
n=21 Participants
GFeBGS consisting of beta-tricalcium phosphate + 0.1% recombinant human basic fibroblast growth factor (rh-bFGF)
|
GFeBGS 0.3%
n=22 Participants
GFeBGS consisting of beta-tricalcium phosphate + 0.3% rh-bFGF
|
GFeGBS 0.4%
n=23 Participants
GFeBGS consisting of beta-tricalcium phosphate + 0.4% rh-bFGF
|
Total
n=88 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
56.5 years
STANDARD_DEVIATION 10.7 • n=99 Participants
|
59.7 years
STANDARD_DEVIATION 12.1 • n=107 Participants
|
54.0 years
STANDARD_DEVIATION 10.6 • n=206 Participants
|
54.0 years
STANDARD_DEVIATION 10.5 • n=7 Participants
|
56.0 years
STANDARD_DEVIATION 11.0 • n=31 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
34 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
54 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
10 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
22 Participants
n=7 Participants
|
78 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
18 Participants
n=7 Participants
|
63 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Smoking history
Current smoker or smoked within past 6 months
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
13 Participants
n=31 Participants
|
|
Smoking history
Non-smoker
|
19 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
20 Participants
n=7 Participants
|
75 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: 6 months post-surgeryPopulation: The modified Intent-to-Treat population consisted of 83 subjects after two subjects were removed for lack of compliance with the study protocol.
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.
Outcome measures
| Measure |
Beta-tricalcium Phosphate Alone
n=20 Participants
beta-tricalcium phosphate + placebo vehicle
|
GFeBGS 0.1%
n=21 Participants
GFeBGS consisting of beta-tricalcium phosphate + 0.1% recombinant human basic fibroblast growth factor (rh-bFGF)
|
GFeBGS 0.3%
n=21 Participants
GFeBGS consisting of beta-tricalcium phosphate + 0.3% rh-bFGF
|
GFeGBS 0.4%
n=21 Participants
GFeBGS consisting of beta-tricalcium phosphate + 0.4% rh-bFGF
|
|---|---|---|---|---|
|
Number of Participants That Met the Success Criteria of Radiographic and Clinical Measurements
|
16 Participants
|
15 Participants
|
19 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: Baseline and 3 months post-surgeryPopulation: The modified Intent-to-Treat population consisted of 84 subjects after a subject was removed for lack of compliance with the study protocol.
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)
Outcome measures
| Measure |
Beta-tricalcium Phosphate Alone
n=20 Participants
beta-tricalcium phosphate + placebo vehicle
|
GFeBGS 0.1%
n=21 Participants
GFeBGS consisting of beta-tricalcium phosphate + 0.1% recombinant human basic fibroblast growth factor (rh-bFGF)
|
GFeBGS 0.3%
n=21 Participants
GFeBGS consisting of beta-tricalcium phosphate + 0.3% rh-bFGF
|
GFeGBS 0.4%
n=22 Participants
GFeBGS consisting of beta-tricalcium phosphate + 0.4% rh-bFGF
|
|---|---|---|---|---|
|
Change in Clinical Attachment Level at 3 Months
|
3.1 mm
Standard Deviation 1.4
|
2.9 mm
Standard Deviation 1.7
|
3.1 mm
Standard Deviation 1.6
|
3.5 mm
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: Baseline and 6 months post-surgeryPopulation: The modified Intent-to-Treat population consisted of 83 subjects after two subjects were removed for lack of compliance with the study protocol.
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)
Outcome measures
| Measure |
Beta-tricalcium Phosphate Alone
n=20 Participants
beta-tricalcium phosphate + placebo vehicle
|
GFeBGS 0.1%
n=21 Participants
GFeBGS consisting of beta-tricalcium phosphate + 0.1% recombinant human basic fibroblast growth factor (rh-bFGF)
|
GFeBGS 0.3%
n=21 Participants
GFeBGS consisting of beta-tricalcium phosphate + 0.3% rh-bFGF
|
GFeGBS 0.4%
n=21 Participants
GFeBGS consisting of beta-tricalcium phosphate + 0.4% rh-bFGF
|
|---|---|---|---|---|
|
Change in Clinical Attachment Level at 6 Months
|
2.9 mm
Standard Deviation 2.1
|
2.5 mm
Standard Deviation 2.1
|
3.0 mm
Standard Deviation 1.4
|
3.6 mm
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: Baseline and 6 months post-surgeryPopulation: The modified Intent-to-Treat population consisted of 83 subjects after two subjects were removed for lack of compliance with the study protocol.
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)
Outcome measures
| Measure |
Beta-tricalcium Phosphate Alone
n=20 Participants
beta-tricalcium phosphate + placebo vehicle
|
GFeBGS 0.1%
n=21 Participants
GFeBGS consisting of beta-tricalcium phosphate + 0.1% recombinant human basic fibroblast growth factor (rh-bFGF)
|
GFeBGS 0.3%
n=21 Participants
GFeBGS consisting of beta-tricalcium phosphate + 0.3% rh-bFGF
|
GFeGBS 0.4%
n=21 Participants
GFeBGS consisting of beta-tricalcium phosphate + 0.4% rh-bFGF
|
|---|---|---|---|---|
|
Linear Bone Growth at 6 Months
|
3.1 mm
Standard Deviation 1.8
|
3.0 mm
Standard Deviation 1.2
|
3.7 mm
Standard Deviation 1.3
|
3.6 mm
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: Baseline and 6 months post-surgeryPopulation: The modified Intent-to-Treat population consisted of 83 subjects after two subjects were removed for lack of compliance with the study protocol.
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.
Outcome measures
| Measure |
Beta-tricalcium Phosphate Alone
n=20 Participants
beta-tricalcium phosphate + placebo vehicle
|
GFeBGS 0.1%
n=21 Participants
GFeBGS consisting of beta-tricalcium phosphate + 0.1% recombinant human basic fibroblast growth factor (rh-bFGF)
|
GFeBGS 0.3%
n=21 Participants
GFeBGS consisting of beta-tricalcium phosphate + 0.3% rh-bFGF
|
GFeGBS 0.4%
n=21 Participants
GFeBGS consisting of beta-tricalcium phosphate + 0.4% rh-bFGF
|
|---|---|---|---|---|
|
Percent Bone Fill at 6 Months
|
62.5 percentage of bone height change
Standard Deviation 26.4
|
61.0 percentage of bone height change
Standard Deviation 23.0
|
74.6 percentage of bone height change
Standard Deviation 20
|
71.1 percentage of bone height change
Standard Deviation 37.8
|
SECONDARY outcome
Timeframe: Baseline and 3 months post-surgeryPopulation: The modified Intent-to-Treat population consisted of 84 subjects after a subject was removed for lack of compliance with the study protocol.
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)
Outcome measures
| Measure |
Beta-tricalcium Phosphate Alone
n=20 Participants
beta-tricalcium phosphate + placebo vehicle
|
GFeBGS 0.1%
n=21 Participants
GFeBGS consisting of beta-tricalcium phosphate + 0.1% recombinant human basic fibroblast growth factor (rh-bFGF)
|
GFeBGS 0.3%
n=21 Participants
GFeBGS consisting of beta-tricalcium phosphate + 0.3% rh-bFGF
|
GFeGBS 0.4%
n=22 Participants
GFeBGS consisting of beta-tricalcium phosphate + 0.4% rh-bFGF
|
|---|---|---|---|---|
|
Pocket Depth Change at 3 Months
|
3.7 mm
Standard Deviation 1.4
|
3.5 mm
Standard Deviation 1.4
|
3.5 mm
Standard Deviation 1.6
|
3.8 mm
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: Baseline and 6 months post-surgeryPopulation: The modified Intent-to-Treat population consisted of 83 subjects after two subjects were removed for lack of compliance with the study protocol.
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)
Outcome measures
| Measure |
Beta-tricalcium Phosphate Alone
n=20 Participants
beta-tricalcium phosphate + placebo vehicle
|
GFeBGS 0.1%
n=21 Participants
GFeBGS consisting of beta-tricalcium phosphate + 0.1% recombinant human basic fibroblast growth factor (rh-bFGF)
|
GFeBGS 0.3%
n=21 Participants
GFeBGS consisting of beta-tricalcium phosphate + 0.3% rh-bFGF
|
GFeGBS 0.4%
n=22 Participants
GFeBGS consisting of beta-tricalcium phosphate + 0.4% rh-bFGF
|
|---|---|---|---|---|
|
Pocket Depth Change at 6 Months
|
3.7 mm
Standard Deviation 1.2
|
2.9 mm
Standard Deviation 2.0
|
3.4 mm
Standard Deviation 1.0
|
3.7 mm
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Baseline and 3 months post-surgeryPopulation: The modified Intent-to-Treat population consisted of 84 subjects after a subject was removed for lack of compliance with the study protocol.
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)
Outcome measures
| Measure |
Beta-tricalcium Phosphate Alone
n=20 Participants
beta-tricalcium phosphate + placebo vehicle
|
GFeBGS 0.1%
n=21 Participants
GFeBGS consisting of beta-tricalcium phosphate + 0.1% recombinant human basic fibroblast growth factor (rh-bFGF)
|
GFeBGS 0.3%
n=21 Participants
GFeBGS consisting of beta-tricalcium phosphate + 0.3% rh-bFGF
|
GFeGBS 0.4%
n=21 Participants
GFeBGS consisting of beta-tricalcium phosphate + 0.4% rh-bFGF
|
|---|---|---|---|---|
|
Change in Gingival Recession at 3 Months
|
-0.6 mm
Standard Deviation 1.4
|
-0.6 mm
Standard Deviation 1.1
|
-0.3 mm
Standard Deviation 1.2
|
-0.3 mm
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: Baseline and 6 months post-surgeryPopulation: The modified Intent-to-Treat population consisted of 83 subjects after two subjects were removed for lack of compliance with the study protocol.
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)
Outcome measures
| Measure |
Beta-tricalcium Phosphate Alone
n=20 Participants
beta-tricalcium phosphate + placebo vehicle
|
GFeBGS 0.1%
n=21 Participants
GFeBGS consisting of beta-tricalcium phosphate + 0.1% recombinant human basic fibroblast growth factor (rh-bFGF)
|
GFeBGS 0.3%
n=21 Participants
GFeBGS consisting of beta-tricalcium phosphate + 0.3% rh-bFGF
|
GFeGBS 0.4%
n=21 Participants
GFeBGS consisting of beta-tricalcium phosphate + 0.4% rh-bFGF
|
|---|---|---|---|---|
|
Change in Gingival Recession at 6 Months
|
-0.7 mm
Standard Deviation 1.5
|
-0.4 mm
Standard Deviation 1.0
|
-0.4 mm
Standard Deviation 1.1
|
-0.1 mm
Standard Deviation 1.3
|
POST_HOC outcome
Timeframe: 6 months post-surgeryPopulation: The modified Intent-to-Treat population consisted of 83 subjects after two subjects were removed for lack of compliance with the study protocol.
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.
Outcome measures
| Measure |
Beta-tricalcium Phosphate Alone
n=20 Participants
beta-tricalcium phosphate + placebo vehicle
|
GFeBGS 0.1%
n=21 Participants
GFeBGS consisting of beta-tricalcium phosphate + 0.1% recombinant human basic fibroblast growth factor (rh-bFGF)
|
GFeBGS 0.3%
n=21 Participants
GFeBGS consisting of beta-tricalcium phosphate + 0.3% rh-bFGF
|
GFeGBS 0.4%
n=21 Participants
GFeBGS consisting of beta-tricalcium phosphate + 0.4% rh-bFGF
|
|---|---|---|---|---|
|
Number of Participants That Met the Success Criteria of Radiographic and Clinical Measurements (Updated Success Criteria)
|
9 Participants
|
10 Participants
|
15 Participants
|
15 Participants
|
Adverse Events
Beta-tricalcium Phosphate Alone
GFeBGS 0.1%
GFeBGS 0.3%
GFeGBS 0.4%
Serious adverse events
| Measure |
Beta-tricalcium Phosphate Alone
n=22 participants at risk
beta-tricalcium phosphate + placebo vehicle
|
GFeBGS 0.1%
n=21 participants at risk
GFeBGS consisting of beta-tricalcium phosphate + 0.1% recombinant human basic fibroblast growth factor (rh-bFGF)
|
GFeBGS 0.3%
n=22 participants at risk
GFeBGS consisting of beta-tricalcium phosphate + 0.3% rh-bFGF
|
GFeGBS 0.4%
n=23 participants at risk
GFeBGS consisting of beta-tricalcium phosphate + 0.4% rh-bFGF
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Bunion
|
4.5%
1/22 • 6 months
|
0.00%
0/21 • 6 months
|
0.00%
0/22 • 6 months
|
0.00%
0/23 • 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma basal
|
0.00%
0/22 • 6 months
|
4.8%
1/21 • 6 months
|
0.00%
0/22 • 6 months
|
0.00%
0/23 • 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukemia
|
0.00%
0/22 • 6 months
|
0.00%
0/21 • 6 months
|
4.5%
1/22 • 6 months
|
0.00%
0/23 • 6 months
|
|
Nervous system disorders
Coma
|
4.5%
1/22 • 6 months
|
0.00%
0/21 • 6 months
|
0.00%
0/22 • 6 months
|
0.00%
0/23 • 6 months
|
Other adverse events
| Measure |
Beta-tricalcium Phosphate Alone
n=22 participants at risk
beta-tricalcium phosphate + placebo vehicle
|
GFeBGS 0.1%
n=21 participants at risk
GFeBGS consisting of beta-tricalcium phosphate + 0.1% recombinant human basic fibroblast growth factor (rh-bFGF)
|
GFeBGS 0.3%
n=22 participants at risk
GFeBGS consisting of beta-tricalcium phosphate + 0.3% rh-bFGF
|
GFeGBS 0.4%
n=23 participants at risk
GFeBGS consisting of beta-tricalcium phosphate + 0.4% rh-bFGF
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Application site pain
|
0.00%
0/22 • 6 months
|
19.0%
4/21 • 6 months
|
9.1%
2/22 • 6 months
|
21.7%
5/23 • 6 months
|
|
Injury, poisoning and procedural complications
Application site inflammation
|
4.5%
1/22 • 6 months
|
4.8%
1/21 • 6 months
|
0.00%
0/22 • 6 months
|
21.7%
5/23 • 6 months
|
|
Injury, poisoning and procedural complications
Application site hyperaesthesia
|
9.1%
2/22 • 6 months
|
9.5%
2/21 • 6 months
|
4.5%
1/22 • 6 months
|
0.00%
0/23 • 6 months
|
|
Infections and infestations
Tooth abscess
|
9.1%
2/22 • 6 months
|
0.00%
0/21 • 6 months
|
0.00%
0/22 • 6 months
|
4.3%
1/23 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER