N/A
N=45
Assessment of Ridge Preservation Using Moldable Beta-tricalcium Phosphate Bone Grafting System
Dental Implants · Alveolar Ridge Preservation
Bottom Line
View on ClinicalTrials.gov: NCT02702609 ↗Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcome: Primary: Change in Radiographic Measurements of Ridge Dimension (Horizontal Ridge Width) — 1.26; 1.28 mm
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- easy-graft CLASSIC (Device); FDBA with collagen plug (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sunstar Americas
- Primary completion
- Aug 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Radiographic Measurements of Ridge Dimension (Horizontal Ridge Width) |
1.26; 1.28 | — |
| PRIMARY Change in Radiographic Measurements of Ridge Dimension (Volumetric Assessment) |
23.9; 17.0 | — |
| SECONDARY Histomorphometric Assessment of Newly Formed Mineralized Tissue |
27.0; 38.2 | — |
| SECONDARY Histomorphometric Assessment of Residual Bone Graft Particles |
20.5; 15.7 | — |
| SECONDARY Histomorphometric Assessment of Non-mineralized Tissue |
52.5; 46.1 | — |
| SECONDARY Change of Marginal Bone Level Around Dental Implant |
0.04; 0.06; 0.12; -0.05; 0.02; 0.02 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02702609). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.