Assessment of Ridge Preservation Using Moldable Beta-tricalcium Phosphate Bone Grafting System
Status: | Active, not recruiting |
---|---|
Conditions: | Dental |
Therapuetic Areas: | Dental / Maxillofacial Surgery |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 9/7/2018 |
Start Date: | August 2, 2016 |
End Date: | September 2019 |
Prospective, Comparative Assessment of Alveolar Ridge Preservation Using GUIDOR® Easy-graft® Classic in Atraumatic Extraction Socket
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.
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.
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
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