Oral Surgery, Periodontology
Conditions
Brief summary
A case series to compare the handling and effectiveness of two different treatment approaches using a new alloplastic bone graft material in ridge preservation compared to allograft existing historical data.
Interventions
DEVICEeasy-graft (beta-Tricalcium Phosphate)
Sponsors
Sunstar Americas
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Must have read, understood and signed a consent form. * 18-75 years of age * Diagnosis with a need of extraction of single tooth (with intact extraction socket at the time of extraction) with adjacent teeth present.
Exclusion criteria
* Active caries or endodontic lesions in adjacent teeth * Any systemic disease or condition that would compromise the normal healing. (e.g., uncontrolled diabetes) * Taking any medication known for gingival hyperplasia for past 3 months. * Any systemic contraindications to surgery * Subject smokes \> 10 cigarettes per day.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Change in Radiographic Measurement of Alveolar Ridge Height | Change from baseline to 6 months | Radiographic measurement was taken at most-middle portion of the grafted site, perpendicular to the line drawn from reference point (e.g. adjacent tooth/teeth Cement-Enamel Junction (CEJ) or margin of the restoration). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| New Alloplastic Bone Graft Material easy-graft (beta-Tricalcium Phosphate) | 8 |
| Total | 8 |
Baseline characteristics
| Characteristic | New Alloplastic Bone Graft Material |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants |
| Deepest vertical depth | 10.0 mm STANDARD_DEVIATION 2.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 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 | 6 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 4 Participants |
| Widest open | 8.3 mm STANDARD_DEVIATION 2.5 |
| Widest ridge width | 9.3 mm STANDARD_DEVIATION 2.5 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 8 |
| other Total, other adverse events | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 |
Outcome results
Primary
Percentage Change in Radiographic Measurement of Alveolar Ridge Height
Radiographic measurement was taken at most-middle portion of the grafted site, perpendicular to the line drawn from reference point (e.g. adjacent tooth/teeth Cement-Enamel Junction (CEJ) or margin of the restoration).
Time frame: Change from baseline to 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| New Alloplastic Bone Graft Material | Percentage Change in Radiographic Measurement of Alveolar Ridge Height | 1.2 percentage of change | Standard Deviation 6.2 |