An interventional study of easy-graft CLASSIC (beta-Tricalcium Phosphate) in Alveolar Ridge Preservation and Dental Implants, sponsored by Sunstar Americas. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-25.
Sponsored by Sunstar Americas · Not applicable, Interventional, and Treatment
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.
Sunstar Americas is the lead sponsor of 9 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
easy-graft CLASSIC (beta-Tricalcium Phosphate) grafting covered with polylactide membrane
Device: 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.
Also known as: GUIDOR Bioresorbable Matrix Barrier
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
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
| Milestone | Device Treatment |
|---|---|
| Started | 9 |
| Completed | 5 |
| Not completed | 4 |
| Withdrew: Physician decision | 4 |
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.
| mm | Device Treatment |
|---|---|
| Overall | 1.59 ± 1.05 |
| 1 mm below the alveolar bone crest | 1.89 ± 1.03 |
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.
| mm | Device Treatment |
|---|---|
| Overall | 0.99 ± 2.18 |
| 1mm below the ridge crest | 2.57 ± 1.35 |
Collected over 5 months after ridge preservation surgery. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Device Treatment | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) |
| Age, Continuous(years) | Device Treatment |
|---|---|
| Mean | 58.6 ± 15.3 |
| Sex: Female, Male(Participants) | Device Treatment |
|---|---|
| Female | 6 |
| Male | 3 |
| Ethnicity (NIH/OMB)(Participants) | Device Treatment |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 9 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Device Treatment |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 7 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is terminated, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Sunstar Americas