Prospective, Comparative Assessment of Alveolar Ridge Preservation Using GUIDOR® Easy-graft® Classic in Atraumatic Extraction Socket
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 45
- Locations
- 4
- Primary Endpoint
- Change in Radiographic Measurements of Ridge Dimension (Horizontal Ridge Width)
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Change in Radiographic Measurements of Ridge Dimension (Horizontal Ridge Width)
Time Frame: Baseline and 4 months post-surgery
Cone-beam computed tomography (CBCT) is taken at the ridge preservation procedure (baseline) and 4 months after the procedure. Linear measurement of horizontal ridge width is measured at 1 mm apical to the crest. Change of horizontal ridge width = (Baseline measurement - 4 months measurement)
Change in Radiographic Measurements of Ridge Dimension (Volumetric Assessment)
Time Frame: Baseline and 4 months post-surgery
Cone-beam computed tomography (CBCT) is taken at the ridge preservation procedure (baseline) and 4 months after the procedure. Bone volume measurement is expressed in mm3, which allowed for a calculation of the % of volumetric reduction that took place from baseline to 4 months post-surgery.
Secondary Outcomes
- Histomorphometric Assessment of Newly Formed Mineralized Tissue(5 months post-surgery)
- Histomorphometric Assessment of Non-mineralized Tissue(5 months post-surgery)
- Change of Marginal Bone Level Around Dental Implant(Baseline, 6, and 12 months after crown delivery)
- Histomorphometric Assessment of Residual Bone Graft Particles(5 months post-surgery)