Clinical trial NCT02702609: Assessment of Ridge Preservation Using Moldable Beta-tricalcium Phosphate Bone Grafting System
Official title: Prospective, Comparative Assessment of Alveolar Ridge Preservation Using GUIDOR® Easy-graft® Classic in Atraumatic Extraction Socket
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Implants
Alveolar Ridge Preservation
Lead sponsor: Sunstar Americas
Sponsor class: INDUSTRY
First posted: 2016-03-08
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in Radiographic Measurements of Ridge Dimension (Horizontal Ridge Width)
timeFrame: Baseline and 4 months post-surgery
measure: Change in Radiographic Measurements of Ridge Dimension (Volumetric Assessment)
timeFrame: Baseline and 4 months post-surgery
Secondary outcomes:
measure: Histomorphometric Assessment of Newly Formed Mineralized Tissue
timeFrame: 5 months post-surgery
measure: Histomorphometric Assessment of Residual Bone Graft Particles
timeFrame: 5 months post-surgery
measure: Histomorphometric Assessment of Non-mineralized Tissue
timeFrame: 5 months post-surgery
measure: Change of Marginal Bone Level Around Dental Implant
timeFrame: Baseline, 6, and 12 months after crown delivery
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: The University of Iowa College of Dentistry
state: Iowa
city: Baltimore
country: United States
facility: University of Maryland School of Dentistry
state: Maryland
Study officials:
References: