Alveolar Ridge Preservation, Dental Implants
Conditions
Brief summary
Purpose of the single arm study is to clinically and histologically evaluate alloplastic in-situ hardening, moldable beta-tricalcium phosphate(TCP) bone graft material and polylactide membrane in alveolar ridge preservation following extraction of non-molar teeth with non-containable extraction sockets.
Interventions
easy-graft will be grafted to a single extraction socket and covered by polylactide membrane to facilitate regeneration of new bone in order to preserve alveolar ridge dimensions.
Sponsors
Sunstar Americas
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adequate restorative space for a dental implant restoration, if the subject decides previous to study participation that they would like an implant. Note, agreement to implant placement is not a requirement of the study * minimum of 10-mm vertical bone without impinging on adjacent vital structures (Maxillary sinus, neurovascular bundles) * single-rooted tooth to be extracted * American Society of Anesthesiologists (ASA) Physical Status Classification I or II * age \>18 years old * subjects who had \>50% of height on any portion on the buccal wall of dehiscence and/or fenestration of the extraction socket following extraction will be included from this study * adjacent teeth to extraction site will be present during healing period * willingly sign informed consent and authorization.
Exclusion criteria
* do not meet any inclusion criteria * pregnancy or nursing woman * subjects with active systemic or localized infection (exclude chronic periodontitis) * subjects with a history of any medical conditions that contraindicated or weighed against dental implant placement such as history of bisphosphonate drug use, chemotherapeutic or immunosuppressive agents, autoimmune disease, or poorly controlled diabetes (HBA1c\>7%) * subjects with smoking habit (more than 10 cigarettes per day)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Radiographic Measurements of Bone Ridge Dimensions | Change from Baseline at 3 months | Cone-beam computed tomography (CBCT) was taken at the ridge preservation procedure (baseline) and 3 months after the procedure. The horizontal ridge width was measured at 1, 3, 5 and 7 mm below the alveolar bone crest. Overall change is the average of all measurements. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Digital Measurements of Soft Tissue Dimensions | Change from baseline at 5 months | Pre- and post-surgery casts were made from impressions and scanned with a digital scanner. The soft tissue width was measured at 1, 3 and 5 mm below the ridge crest. Overall change is the average of all measurements. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Device Treatment easy-graft CLASSIC (beta-Tricalcium Phosphate) grafting covered with polylactide membrane
easy-graft CLASSIC (beta-Tricalcium Phosphate): easy-graft will be grafted to a single extraction socket and covered by polylactide membrane to facilitate regeneration of new bone in order to preserve alveolar ridge dimensions. | 9 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 4 |
Baseline characteristics
| Characteristic | Device Treatment |
|---|---|
| Age, Continuous | 58.6 years STANDARD_DEVIATION 15.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 7 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 9 |
| other Total, other adverse events | 0 / 9 |
| serious Total, serious adverse events | 0 / 9 |
Outcome results
Primary
Change in Radiographic Measurements of Bone Ridge Dimensions
Cone-beam computed tomography (CBCT) was taken at the ridge preservation procedure (baseline) and 3 months after the procedure. The horizontal ridge width was measured at 1, 3, 5 and 7 mm below the alveolar bone crest. Overall change is the average of all measurements.
Time frame: Change from Baseline at 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Device Treatment | Change in Radiographic Measurements of Bone Ridge Dimensions | Overall | 1.59 mm | Standard Deviation 1.05 |
| Device Treatment | Change in Radiographic Measurements of Bone Ridge Dimensions | 1 mm below the alveolar bone crest | 1.89 mm | Standard Deviation 1.03 |
Secondary
Change in Digital Measurements of Soft Tissue Dimensions
Pre- and post-surgery casts were made from impressions and scanned with a digital scanner. The soft tissue width was measured at 1, 3 and 5 mm below the ridge crest. Overall change is the average of all measurements.
Time frame: Change from baseline at 5 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Device Treatment | Change in Digital Measurements of Soft Tissue Dimensions | Overall | 0.99 mm | Standard Deviation 2.18 |
| Device Treatment | Change in Digital Measurements of Soft Tissue Dimensions | 1mm below the ridge crest | 2.57 mm | Standard Deviation 1.35 |