Assessment of Ridge Preservation Using Moldable Beta-tricalcium Phosphate Bone Grafting System
Study Details
Study Description
Brief Summary
Randomized Controlled study to compare the effectiveness of two different treatment approaches using a new moldable beta-tricalcium phosphate(TCP) bone graft material in ridge preservation of an atraumatic extraction socket site compared to allograft with collagen plug.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Moldable beta-TCP grafting system Device: easy-graft CLASSIC (beta-Tricalcium Phosphate) |
Device: easy-graft CLASSIC
easy-graft will be grafted to a single extraction socket to preserve the ridge dimension for future implant placement.
|
| Active Comparator: Allograft Device: Freeze-Dried Bone Allograft (FDBA) with collagen plug |
Device: 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.
|
Outcome Measures
Primary Outcome Measures
- Change in Radiographic Measurements of Ridge Dimension (Horizontal Ridge Width) [Baseline and 4 months post-surgery]
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)
- Change in Radiographic Measurements of Ridge Dimension (Volumetric Assessment) [Baseline and 4 months post-surgery]
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.
Secondary Outcome Measures
- Histomorphometric Assessment of Newly Formed Mineralized Tissue [5 months post-surgery]
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.
- Histomorphometric Assessment of Residual Bone Graft Particles [5 months post-surgery]
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.
- Histomorphometric Assessment of Non-mineralized Tissue [5 months post-surgery]
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 non-mineralized tissue respective to the percent of the total core area.
- Change of Marginal Bone Level Around Dental Implant [Baseline, 6, and 12 months after crown delivery]
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)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Provision of informed consent
-
At least 18 years old
-
In need of one posterior tooth, excluding third molar molars, planned for extraction and replacement with a dental implant (If the subject requires two adjacent socket preservation, they can still be enrolled in the study but only one site will be used for the study)
-
Intact ridge as verified with cone-beam CT scan
-
At least one natural tooth adjacent to the study site present.
Exclusion Criteria:
-
Insufficient interocclusal space to allow for implant supported prosthesis
-
Dehiscence or fenestration identified at the time of reviewing CBCT.
-
Non-treated caries or uncontrolled periodontal disease present affecting the teeth in adjacent to study teeth.
-
Any of natural teeth adjacent to the study site presents active periapical endodontic lesion ("active periapical endodontic lesion" will be determined per consultation by endodontics specialist).
-
Adjacent tooth (mesial and distal) to study site was extracted within last 6 months
-
Adjacent teeth (or tooth) to study site with significant soft tissue loss
-
Smoker using more than 10 cigarettes or equivalent per day
-
Smokeless tobacco use or e-cigarette use
-
Current alcohol or drug abuser
-
Systemic or local disease or condition that would compromise post-operative healing and/or osseointegration e.g. uncontrolled diabetes
-
Need for systemic corticosteroids or any other medication that would influence post-operative healing and/or osseointegration
-
Pregnancy, as indicated by positive serum human chorionic gonadotropin (HCG) test result.
-
Unable or unwilling to return for follow-up visits for a period of 5 months
-
Unlikely to be able to comply with study procedures according to Investigators judgement
-
Subject in other clinical trials
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The University of Iowa College of Dentistry | Iowa City | Iowa | United States | 52242 |
| 2 | University of Maryland School of Dentistry | Baltimore | Maryland | United States | 21201 |
Sponsors and Collaborators
- Sunstar Americas
Investigators
None specified.Study Documents (Full-Text)
More Information
Publications
None provided.- CLP-2015-12-17-1
Study Results
Participant Flow
| Recruitment Details | Participants were recruited and enrolled at 2 dental schools between August 2016 and June 2017. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Moldable Beta-TCP Grafting System | Allograft |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Period Title: Overall Study | ||
| STARTED | 24 | 21 |
| Implant Placement | 23 | 21 |
| Crown Delivery | 16 | 18 |
| COMPLETED | 15 | 17 |
| NOT COMPLETED | 9 | 4 |
Baseline Characteristics
| Arm/Group Title | Moldable Beta-TCP Grafting System | Allograft | Total |
|---|---|---|---|
| Arm/Group Description | 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. | 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 of all reporting groups |
| Overall Participants | 24 | 21 | 45 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
61.3
(11.2)
|
53.5
(11.4)
|
57.6
(11.9)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
15
62.5%
|
14
66.7%
|
29
64.4%
|
| Male |
9
37.5%
|
7
33.3%
|
16
35.6%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
1
4.2%
|
1
4.8%
|
2
4.4%
|
| Not Hispanic or Latino |
23
95.8%
|
20
95.2%
|
43
95.6%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
1
4.8%
|
1
2.2%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
2
8.3%
|
4
19%
|
6
13.3%
|
| White |
22
91.7%
|
16
76.2%
|
38
84.4%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Smoking history (Count of Participants) | |||
| Smoker |
1
4.2%
|
2
9.5%
|
3
6.7%
|
| Non-smoker |
23
95.8%
|
19
90.5%
|
42
93.3%
|
Outcome Measures
| Title | Change in Radiographic Measurements of Ridge Dimension (Horizontal Ridge Width) |
|---|---|
| Description | 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) |
| Time Frame | Baseline and 4 months post-surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| The modified Intent-to-Treat population consisted of 43 subjects after a subject was removed for lack of compliance with the study protocol. |
| Arm/Group Title | Moldable Beta-TCP Grafting System | Allograft |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 23 | 20 |
| Mean (Standard Deviation) [mm] |
1.26
(1.32)
|
1.28
(1.73)
|
| Title | Change in Radiographic Measurements of Ridge Dimension (Volumetric Assessment) |
|---|---|
| Description | 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. |
| Time Frame | Baseline and 4 months post-surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| The modified Intent-to-Treat population consisted of 43 subjects after a subject was removed for lack of compliance with the study protocol. |
| Arm/Group Title | Moldable Beta-TCP Grafting System | Allograft |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 23 | 20 |
| Mean (Standard Deviation) [percentage of volume at baseline] |
23.9
(22.1)
|
17.0
(15.4)
|
| Title | Histomorphometric Assessment of Newly Formed Mineralized Tissue |
|---|---|
| Description | 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. |
| Time Frame | 5 months post-surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| The modified Intent-to-Treat population consisted of 43 subjects after a subject was removed for lack of compliance with the study protocol. |
| Arm/Group Title | Moldable Beta-TCP Grafting System | Allograft |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 23 | 20 |
| Mean (Standard Deviation) [percentage of total core area] |
27.0
(22.1)
|
38.2
(12.5)
|
| Title | Histomorphometric Assessment of Residual Bone Graft Particles |
|---|---|
| Description | 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. |
| Time Frame | 5 months post-surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| The modified Intent-to-Treat population consisted of 43 subjects after a subject was removed for lack of compliance with the study protocol. |
| Arm/Group Title | Moldable Beta-TCP Grafting System | Allograft |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 23 | 20 |
| Mean (Standard Deviation) [percentage of total core area] |
20.5
(16.8)
|
15.7
(7.0)
|
| Title | Histomorphometric Assessment of Non-mineralized Tissue |
|---|---|
| Description | 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 non-mineralized tissue respective to the percent of the total core area. |
| Time Frame | 5 months post-surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Moldable Beta-TCP Grafting System | Allograft |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 23 | 20 |
| Mean (Standard Deviation) [percentage of total core area] |
52.5
(11.8)
|
46.1
(10.5)
|
| Title | Change of Marginal Bone Level Around Dental Implant |
|---|---|
| Description | 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) |
| Time Frame | Baseline, 6, and 12 months after crown delivery |
Outcome Measure Data
| Analysis Population Description |
|---|
| 34 subjects received crown delivery on the study site after implant placement and two subjects were lost to follow-up. |
| Arm/Group Title | Moldable Beta-TCP Grafting System | Allograft |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 15 | 17 |
| Mesial 6 months |
0.04
(0.06)
|
0.06
(0.07)
|
| Distal 6 months |
0.12
(0.05)
|
-0.05
(0.06)
|
| Mesial 12 months |
0.02
(0.07)
|
0.02
(0.09)
|
| Distal 12 months |
0.09
(0.08)
|
0.09
(0.07)
|
Adverse Events
| Time Frame | One year after crown delivery | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Moldable Beta-TCP Grafting System | Allograft | ||
| Arm/Group Description | 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. | 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. | ||
All Cause Mortality |
||||
| Moldable Beta-TCP Grafting System | Allograft | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/24 (0%) | 0/21 (0%) | ||
Serious Adverse Events |
||||
| Moldable Beta-TCP Grafting System | Allograft | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/24 (0%) | 0/21 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Moldable Beta-TCP Grafting System | Allograft | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2/24 (8.3%) | 1/21 (4.8%) | ||
| Cardiac disorders | ||||
| Arrhythmia | 1/24 (4.2%) | 1 | 0/21 (0%) | 0 |
| General disorders | ||||
| Dental restoration failure | 1/24 (4.2%) | 1 | 0/21 (0%) | 0 |
| Infections and infestations | ||||
| Postoperative wound infection | 1/24 (4.2%) | 1 | 0/21 (0%) | 0 |
| Alveolar osteitis | 0/24 (0%) | 0 | 1/21 (4.8%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Oroantral fistula | 1/24 (4.2%) | 1 | 0/21 (0%) | 0 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
| Name/Title | Akane Takemura |
|---|---|
| Organization | Sunstar Americas, Inc. |
| Phone | 8477944276 |
| akane.takemura@us.sunstar.com |
- CLP-2015-12-17-1