Alveolar Ridge Preservation, Dental Implants
Conditions
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.
Interventions
DEVICEeasy-graft CLASSIC
easy-graft will be grafted to a single extraction socket to preserve the ridge dimension for future implant placement.
DEVICEFDBA 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.
Sponsors
Sunstar Americas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
United States
Participant flow
Recruitment details
Participants were recruited and enrolled at 2 dental schools between August 2016 and June 2017.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 24 |
| 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. | 21 |
| Total | 45 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 8 | 4 |
| Overall Study | Physician Decision | 1 | 0 |
Baseline characteristics
| Characteristic | Moldable Beta-TCP Grafting System | Total | Allograft |
|---|---|---|---|
| Age, Continuous | 61.3 years STANDARD_DEVIATION 11.2 | 57.6 years STANDARD_DEVIATION 11.9 | 53.5 years STANDARD_DEVIATION 11.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 23 Participants | 43 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 6 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 22 Participants | 38 Participants | 16 Participants |
| Sex: Female, Male Female | 15 Participants | 29 Participants | 14 Participants |
| Sex: Female, Male Male | 9 Participants | 16 Participants | 7 Participants |
| Smoking history Non-smoker | 23 Participants | 42 Participants | 19 Participants |
| Smoking history Smoker | 1 Participants | 3 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 21 |
| other Total, other adverse events | 2 / 24 | 1 / 21 |
| serious Total, serious adverse events | 0 / 24 | 0 / 21 |
Outcome results
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)
Time frame: Baseline and 4 months post-surgery
Population: The modified Intent-to-Treat population consisted of 43 subjects after a subject was removed for lack of compliance with the study protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Moldable Beta-TCP Grafting System | Change in Radiographic Measurements of Ridge Dimension (Horizontal Ridge Width) | 1.26 mm | Standard Deviation 1.32 |
| Allograft | Change in Radiographic Measurements of Ridge Dimension (Horizontal Ridge Width) | 1.28 mm | Standard Deviation 1.73 |
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.
Time frame: Baseline and 4 months post-surgery
Population: The modified Intent-to-Treat population consisted of 43 subjects after a subject was removed for lack of compliance with the study protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Moldable Beta-TCP Grafting System | Change in Radiographic Measurements of Ridge Dimension (Volumetric Assessment) | 23.9 percentage of volume at baseline | Standard Deviation 22.1 |
| Allograft | Change in Radiographic Measurements of Ridge Dimension (Volumetric Assessment) | 17.0 percentage of volume at baseline | Standard Deviation 15.4 |
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)
Time frame: Baseline, 6, and 12 months after crown delivery
Population: 34 subjects received crown delivery on the study site after implant placement and two subjects were lost to follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Moldable Beta-TCP Grafting System | Change of Marginal Bone Level Around Dental Implant | Mesial 6 months | 0.04 mm | Standard Deviation 0.06 |
| Moldable Beta-TCP Grafting System | Change of Marginal Bone Level Around Dental Implant | Distal 6 months | 0.12 mm | Standard Deviation 0.05 |
| Moldable Beta-TCP Grafting System | Change of Marginal Bone Level Around Dental Implant | Mesial 12 months | 0.02 mm | Standard Deviation 0.07 |
| Moldable Beta-TCP Grafting System | Change of Marginal Bone Level Around Dental Implant | Distal 12 months | 0.09 mm | Standard Deviation 0.08 |
| Allograft | Change of Marginal Bone Level Around Dental Implant | Distal 12 months | 0.09 mm | Standard Deviation 0.07 |
| Allograft | Change of Marginal Bone Level Around Dental Implant | Mesial 6 months | 0.06 mm | Standard Deviation 0.07 |
| Allograft | Change of Marginal Bone Level Around Dental Implant | Mesial 12 months | 0.02 mm | Standard Deviation 0.09 |
| Allograft | Change of Marginal Bone Level Around Dental Implant | Distal 6 months | -0.05 mm | Standard Deviation 0.06 |
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.
Time frame: 5 months post-surgery
Population: The modified Intent-to-Treat population consisted of 43 subjects after a subject was removed for lack of compliance with the study protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Moldable Beta-TCP Grafting System | Histomorphometric Assessment of Newly Formed Mineralized Tissue | 27.0 percentage of total core area | Standard Deviation 22.1 |
| Allograft | Histomorphometric Assessment of Newly Formed Mineralized Tissue | 38.2 percentage of total core area | Standard Deviation 12.5 |
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.
Time frame: 5 months post-surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Moldable Beta-TCP Grafting System | Histomorphometric Assessment of Non-mineralized Tissue | 52.5 percentage of total core area | Standard Deviation 11.8 |
| Allograft | Histomorphometric Assessment of Non-mineralized Tissue | 46.1 percentage of total core area | Standard Deviation 10.5 |
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.
Time frame: 5 months post-surgery
Population: The modified Intent-to-Treat population consisted of 43 subjects after a subject was removed for lack of compliance with the study protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Moldable Beta-TCP Grafting System | Histomorphometric Assessment of Residual Bone Graft Particles | 20.5 percentage of total core area | Standard Deviation 16.8 |
| Allograft | Histomorphometric Assessment of Residual Bone Graft Particles | 15.7 percentage of total core area | Standard Deviation 7 |