Jaw, Edentulous, Partially Clinical Trial
Official title:
Horizontal and Vertical Dimensional Changes of Peri-implant Facial Bone Following Placement of T3 Implants: a 1-year Cone Beam Computed Tomography Study
Verified date | September 2016 |
Source | Proed |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ethics Committee |
Study type | Interventional |
40 consecutive adult patients, requiring the insertion of dental implants in the aesthetic
area (from second premolar to second premolar) will be enrolled in the study. At the time of
surgery, a full thickness flap will be elevated, the implant bed will be prepared according
to the manufacturer's instruction and the implants will be then seated into the bone. T0
corresponds to the time of implant insertion, T1 to the time of healing abutment's
connection (T0=T1 for single stage implants), and T2 corresponds to 1-year follow-up from
healing abutment's connection.
Cone Beam Computed Tomography (CBCT) scans will be taken immediately after abutment
connection (T1) and 1-year after (T2). The midsagittal cut of each implant will be
identified, and measurements will be made at predetermined levels. Horizontal facial bone
thickness (HFBT) and Vertical facial bone level (VFBL) will be measured. HFBT will be
measured at 0, 3, 6 and 9 mm apical to the implant platform. VFBL wil be the perpendicular
distance from the implant platform to the most coronal point of the facial bone. Changes
between T1 and T2 will be calculated.
Status | Completed |
Enrollment | 40 |
Est. completion date | September 2015 |
Est. primary completion date | October 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 90 Years |
Eligibility |
Inclusion Criteria: Healthy adult patients requiring implant insertion - Exclusion Criteria: Pregnancy history of malignancy history of radiotherapy or chemotherapy in the last 5 years long term steroidal or antibiotic therapy |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Italy | PROED, Institute for Professional Education in Dentistry | Torino |
Lead Sponsor | Collaborator |
---|---|
Proed |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | horizontal buccal bone thickness | On Cone Beam images, the horizontal dimensional changes of peri-implant facial bone will be measured | 12 months after abutment connection | No |
Secondary | vertical bone level | On Cone Beam images, the vertical dimensional changes of peri-implant facial bone will be measured | 1 year after abutment connection | No |
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