Trial Outcomes & Findings for Assessment of Ridge Preservation Using Moldable Beta-tricalcium Phosphate Bone Grafting System (NCT NCT02702609)
NCT ID: NCT02702609
Last Updated: 2020-10-22
Results Overview
Cone-beam computed tomography (CBCT) is taken at the ridge preservation procedure (baseline) and 4 months after the procedure. Linear measurement of horizontal ridge width is measured at 1 mm apical to the crest. Change of horizontal ridge width = (Baseline measurement - 4 months measurement)
COMPLETED
NA
45 participants
Baseline and 4 months post-surgery
2020-10-22
Participant Flow
Participants were recruited and enrolled at 2 dental schools between August 2016 and June 2017.
Participant milestones
| Measure |
Moldable Beta-TCP Grafting System
Device: easy-graft CLASSIC (beta-Tricalcium Phosphate)
easy-graft CLASSIC: easy-graft will be grafted to a single extraction socket to preserve the ridge dimension for future implant placement.
|
Allograft
Device: Freeze-Dried Bone Allograft (FDBA) with collagen plug
FDBA with collagen plug: FDBA will be grafted to a single extraction socket and covered by collagen plug to preserve the ridge dimension for future implant placement.
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
21
|
|
Overall Study
Implant Placement
|
23
|
21
|
|
Overall Study
Crown Delivery
|
16
|
18
|
|
Overall Study
COMPLETED
|
15
|
17
|
|
Overall Study
NOT COMPLETED
|
9
|
4
|
Reasons for withdrawal
| Measure |
Moldable Beta-TCP Grafting System
Device: easy-graft CLASSIC (beta-Tricalcium Phosphate)
easy-graft CLASSIC: easy-graft will be grafted to a single extraction socket to preserve the ridge dimension for future implant placement.
|
Allograft
Device: Freeze-Dried Bone Allograft (FDBA) with collagen plug
FDBA with collagen plug: FDBA will be grafted to a single extraction socket and covered by collagen plug to preserve the ridge dimension for future implant placement.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
8
|
4
|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
Assessment of Ridge Preservation Using Moldable Beta-tricalcium Phosphate Bone Grafting System
Baseline characteristics by cohort
| Measure |
Moldable Beta-TCP Grafting System
n=24 Participants
Device: easy-graft CLASSIC (beta-Tricalcium Phosphate)
easy-graft CLASSIC: easy-graft will be grafted to a single extraction socket to preserve the ridge dimension for future implant placement.
|
Allograft
n=21 Participants
Device: Freeze-Dried Bone Allograft (FDBA) with collagen plug
FDBA with collagen plug: FDBA will be grafted to a single extraction socket and covered by collagen plug to preserve the ridge dimension for future implant placement.
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.3 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
53.5 years
STANDARD_DEVIATION 11.4 • n=7 Participants
|
57.6 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Smoking history
Smoker
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Smoking history
Non-smoker
|
23 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 4 months post-surgeryPopulation: The modified Intent-to-Treat population consisted of 43 subjects after a subject was removed for lack of compliance with the study protocol.
Cone-beam computed tomography (CBCT) is taken at the ridge preservation procedure (baseline) and 4 months after the procedure. Linear measurement of horizontal ridge width is measured at 1 mm apical to the crest. Change of horizontal ridge width = (Baseline measurement - 4 months measurement)
Outcome measures
| Measure |
Moldable Beta-TCP Grafting System
n=23 Participants
Device: easy-graft CLASSIC (beta-Tricalcium Phosphate)
easy-graft CLASSIC: easy-graft will be grafted to a single extraction socket to preserve the ridge dimension for future implant placement.
|
Allograft
n=20 Participants
Device: Freeze-Dried Bone Allograft (FDBA) with collagen plug
FDBA with collagen plug: FDBA will be grafted to a single extraction socket and covered by collagen plug to preserve the ridge dimension for future implant placement.
|
|---|---|---|
|
Change in Radiographic Measurements of Ridge Dimension (Horizontal Ridge Width)
|
1.26 mm
Standard Deviation 1.32
|
1.28 mm
Standard Deviation 1.73
|
PRIMARY outcome
Timeframe: Baseline and 4 months post-surgeryPopulation: The modified Intent-to-Treat population consisted of 43 subjects after a subject was removed for lack of compliance with the study protocol.
Cone-beam computed tomography (CBCT) is taken at the ridge preservation procedure (baseline) and 4 months after the procedure. Bone volume measurement is expressed in mm3, which allowed for a calculation of the % of volumetric reduction that took place from baseline to 4 months post-surgery.
Outcome measures
| Measure |
Moldable Beta-TCP Grafting System
n=23 Participants
Device: easy-graft CLASSIC (beta-Tricalcium Phosphate)
easy-graft CLASSIC: easy-graft will be grafted to a single extraction socket to preserve the ridge dimension for future implant placement.
|
Allograft
n=20 Participants
Device: Freeze-Dried Bone Allograft (FDBA) with collagen plug
FDBA with collagen plug: FDBA will be grafted to a single extraction socket and covered by collagen plug to preserve the ridge dimension for future implant placement.
|
|---|---|---|
|
Change in Radiographic Measurements of Ridge Dimension (Volumetric Assessment)
|
23.9 percentage of volume at baseline
Standard Deviation 22.1
|
17.0 percentage of volume at baseline
Standard Deviation 15.4
|
SECONDARY outcome
Timeframe: 5 months post-surgeryPopulation: The modified Intent-to-Treat population consisted of 43 subjects after a subject was removed for lack of compliance with the study protocol.
Bone core biopsy is harvested at the time of implant placement from the "central" part of the ridge at 5 months after ridge preservation procedure. Histomorphometric analysis is performed by one blinded examiner who measured a proportion of mineralized tissue respective to the percent of the total core area.
Outcome measures
| Measure |
Moldable Beta-TCP Grafting System
n=23 Participants
Device: easy-graft CLASSIC (beta-Tricalcium Phosphate)
easy-graft CLASSIC: easy-graft will be grafted to a single extraction socket to preserve the ridge dimension for future implant placement.
|
Allograft
n=20 Participants
Device: Freeze-Dried Bone Allograft (FDBA) with collagen plug
FDBA with collagen plug: FDBA will be grafted to a single extraction socket and covered by collagen plug to preserve the ridge dimension for future implant placement.
|
|---|---|---|
|
Histomorphometric Assessment of Newly Formed Mineralized Tissue
|
27.0 percentage of total core area
Standard Deviation 22.1
|
38.2 percentage of total core area
Standard Deviation 12.5
|
SECONDARY outcome
Timeframe: 5 months post-surgeryPopulation: The modified Intent-to-Treat population consisted of 43 subjects after a subject was removed for lack of compliance with the study protocol.
Bone core biopsy is harvested at the time of implant placement from the "central" part of the ridge at 5 months after ridge preservation procedure. Histomorphometric analysis is performed by one blinded examiner who measured a proportion of residual bone graft respective to the percent of the total core area.
Outcome measures
| Measure |
Moldable Beta-TCP Grafting System
n=23 Participants
Device: easy-graft CLASSIC (beta-Tricalcium Phosphate)
easy-graft CLASSIC: easy-graft will be grafted to a single extraction socket to preserve the ridge dimension for future implant placement.
|
Allograft
n=20 Participants
Device: Freeze-Dried Bone Allograft (FDBA) with collagen plug
FDBA with collagen plug: FDBA will be grafted to a single extraction socket and covered by collagen plug to preserve the ridge dimension for future implant placement.
|
|---|---|---|
|
Histomorphometric Assessment of Residual Bone Graft Particles
|
20.5 percentage of total core area
Standard Deviation 16.8
|
15.7 percentage of total core area
Standard Deviation 7.0
|
SECONDARY outcome
Timeframe: 5 months post-surgeryBone core biopsy is harvested at the time of implant placement from the "central" part of the ridge at 5 months after ridge preservation procedure. Histomorphometric analysis is performed by one blinded examiner who measured a proportion of non-mineralized tissue respective to the percent of the total core area.
Outcome measures
| Measure |
Moldable Beta-TCP Grafting System
n=23 Participants
Device: easy-graft CLASSIC (beta-Tricalcium Phosphate)
easy-graft CLASSIC: easy-graft will be grafted to a single extraction socket to preserve the ridge dimension for future implant placement.
|
Allograft
n=20 Participants
Device: Freeze-Dried Bone Allograft (FDBA) with collagen plug
FDBA with collagen plug: FDBA will be grafted to a single extraction socket and covered by collagen plug to preserve the ridge dimension for future implant placement.
|
|---|---|---|
|
Histomorphometric Assessment of Non-mineralized Tissue
|
52.5 percentage of total core area
Standard Deviation 11.8
|
46.1 percentage of total core area
Standard Deviation 10.5
|
SECONDARY outcome
Timeframe: Baseline, 6, and 12 months after crown deliveryPopulation: 34 subjects received crown delivery on the study site after implant placement and two subjects were lost to follow-up.
Linear measurement of marginal bone level (MBL) in millimeters along mesial and distal dental implant surface are captured in periapical standardized radiographs at crown delivery (baseline), 6, and 12 months after crown delivery. Change of MBL = (Baseline measurement - 6 or 12 months measurement)
Outcome measures
| Measure |
Moldable Beta-TCP Grafting System
n=15 Participants
Device: easy-graft CLASSIC (beta-Tricalcium Phosphate)
easy-graft CLASSIC: easy-graft will be grafted to a single extraction socket to preserve the ridge dimension for future implant placement.
|
Allograft
n=17 Participants
Device: Freeze-Dried Bone Allograft (FDBA) with collagen plug
FDBA with collagen plug: FDBA will be grafted to a single extraction socket and covered by collagen plug to preserve the ridge dimension for future implant placement.
|
|---|---|---|
|
Change of Marginal Bone Level Around Dental Implant
Mesial 6 months
|
0.04 mm
Standard Deviation 0.06
|
0.06 mm
Standard Deviation 0.07
|
|
Change of Marginal Bone Level Around Dental Implant
Distal 6 months
|
0.12 mm
Standard Deviation 0.05
|
-0.05 mm
Standard Deviation 0.06
|
|
Change of Marginal Bone Level Around Dental Implant
Mesial 12 months
|
0.02 mm
Standard Deviation 0.07
|
0.02 mm
Standard Deviation 0.09
|
|
Change of Marginal Bone Level Around Dental Implant
Distal 12 months
|
0.09 mm
Standard Deviation 0.08
|
0.09 mm
Standard Deviation 0.07
|
Adverse Events
Moldable Beta-TCP Grafting System
Allograft
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Moldable Beta-TCP Grafting System
n=24 participants at risk
Device: easy-graft CLASSIC (beta-Tricalcium Phosphate)
easy-graft CLASSIC: easy-graft will be grafted to a single extraction socket to preserve the ridge dimension for future implant placement.
|
Allograft
n=21 participants at risk
Device: Freeze-Dried Bone Allograft (FDBA) with collagen plug
FDBA with collagen plug: FDBA will be grafted to a single extraction socket and covered by collagen plug to preserve the ridge dimension for future implant placement.
|
|---|---|---|
|
Infections and infestations
Postoperative wound infection
|
4.2%
1/24 • Number of events 1 • One year after crown delivery
|
0.00%
0/21 • One year after crown delivery
|
|
Infections and infestations
Alveolar osteitis
|
0.00%
0/24 • One year after crown delivery
|
4.8%
1/21 • Number of events 1 • One year after crown delivery
|
|
Respiratory, thoracic and mediastinal disorders
Oroantral fistula
|
4.2%
1/24 • Number of events 1 • One year after crown delivery
|
0.00%
0/21 • One year after crown delivery
|
|
Cardiac disorders
Arrhythmia
|
4.2%
1/24 • Number of events 1 • One year after crown delivery
|
0.00%
0/21 • One year after crown delivery
|
|
General disorders
Dental restoration failure
|
4.2%
1/24 • Number of events 1 • One year after crown delivery
|
0.00%
0/21 • One year after crown delivery
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Institution will submit the manuscript of the proposed publication or presentation to Sponsor at least 30 days prior to publication or release, or submission for the publication of any manuscript, 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.
- Publication restrictions are in place
Restriction type: OTHER