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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moldable beta-TCP grafting system | Experimental | Device: easy-graft CLASSIC (beta-Tricalcium Phosphate) |
|
| Allograft | Active Comparator | Device: Freeze-Dried Bone Allograft (FDBA) with collagen plug |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| easy-graft CLASSIC | Device | easy-graft will be grafted to a single extraction socket to preserve the ridge dimension for future implant placement. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Radiographic Measurements of Ridge Dimension (Horizontal Ridge Width) | 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) | Baseline and 4 months post-surgery |
| Change in Radiographic Measurements of Ridge Dimension (Volumetric Assessment) | 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. | Baseline and 4 months post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Histomorphometric Assessment of Newly Formed Mineralized Tissue | 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. | 5 months post-surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Iowa College of Dentistry | Iowa City | Iowa | 52242 | United States | ||
| University of Maryland School of Dentistry |
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Participants were recruited and enrolled at 2 dental schools between August 2016 and June 2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Allograft |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change in Radiographic Measurements of Ridge Dimension (Horizontal Ridge Width) | 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) | The modified Intent-to-Treat population consisted of 43 subjects after a subject was removed for lack of compliance with the study protocol. | Posted | Mean | Standard Deviation | mm | Baseline and 4 months post-surgery |
|
One year after crown delivery
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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 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Postoperative wound infection | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Akane Takemura | Sunstar Americas, Inc. | 8477944276 | akane.takemura@us.sunstar.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 22, 2016 | Sep 29, 2020 | Prot_SAP_000.pdf |
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| FDBA with collagen plug | Device | 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 | 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. | 5 months post-surgery |
| Histomorphometric Assessment of Non-mineralized Tissue | 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. | 5 months post-surgery |
| Change of Marginal Bone Level Around Dental Implant | 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) | Baseline, 6, and 12 months after crown delivery |
| Baltimore |
| Maryland |
| 21201 |
| United States |
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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Smoking history | Count of Participants | Participants |
|
| OG001 | 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. |
|
|
| Primary | Change in Radiographic Measurements of Ridge Dimension (Volumetric Assessment) | 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. | The modified Intent-to-Treat population consisted of 43 subjects after a subject was removed for lack of compliance with the study protocol. | Posted | Mean | Standard Deviation | percentage of volume at baseline | Baseline and 4 months post-surgery |
|
|
|
| Secondary | Histomorphometric Assessment of Newly Formed Mineralized Tissue | 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. | The modified Intent-to-Treat population consisted of 43 subjects after a subject was removed for lack of compliance with the study protocol. | Posted | Mean | Standard Deviation | percentage of total core area | 5 months post-surgery |
|
|
|
| Secondary | Histomorphometric Assessment of Residual Bone Graft Particles | 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. | The modified Intent-to-Treat population consisted of 43 subjects after a subject was removed for lack of compliance with the study protocol. | Posted | Mean | Standard Deviation | percentage of total core area | 5 months post-surgery |
|
|
|
| Secondary | Histomorphometric Assessment of Non-mineralized Tissue | 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. | Posted | Mean | Standard Deviation | percentage of total core area | 5 months post-surgery |
|
|
|
| Secondary | Change of Marginal Bone Level Around Dental Implant | 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) | 34 subjects received crown delivery on the study site after implant placement and two subjects were lost to follow-up. | Posted | Mean | Standard Deviation | mm | Baseline, 6, and 12 months after crown delivery |
|
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| 2 |
| 24 |
| EG001 | 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. | 0 | 21 | 0 | 21 | 1 | 21 |
| Alveolar osteitis | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
|
| Oroantral fistula | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA (19.0) | Non-systematic Assessment | Preexisting condition was updated. |
|
| Dental restoration failure | General disorders | MedDRA (19.0) | Non-systematic Assessment |
|
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.
| Mesial 12 months |
|
| Distal 12 months |
|