Fabrication of a Definitive Cad/Cam Titanium Abutment Prior to Guided Surgery: a Pilot Study.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- Number of Participants With Abutment Margin Exposure > 0
Study Overview
Brief Summary
The study will involve placing a dental implant through a guided surgery protocol developed using 3D CT technology. Because the implant position is planned digitally using the CT data from the patient, this allows investigation of an abutment that supports the implant crown and soft tissues to be fabricated prior to implant placement. In doing so, this makes the protocol for patient care simpler and faster. In fabricating the the abutment prior to surgery, the investigators will design the abutments at different heights below the gumline to see an optimal margin height for fabrication of the abutment prior to surgery. The study hypothesis is that more often the abutment margin placed just slightly below (.5mm) the gumline will be visible about half of the time while the abutment margin placed further under the gumline (1.5mm) will be visible only about 10% of the time. The optimal outcome is that at delivery and follow-up, the abutment margin will not show intraorally.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •partially edentulous with single edentulous space
- •edentulous site where previous tooth has been extracted for at least two months
- •minimum of 20 teeth present
- •able to tolerate dental implant surgical and restorative procedures
- •consent to participate in clinical trial
Exclusion Criteria
- •asa class 3+
- •present drug use
- •is pregnant or plans to become pregnant
- •patients in need of lateral window sinus graft
- •patients in need of grafting prior to implant placement
- •patients in need of extensive grafting at time of implant placement
- •tooth is present or extracted within the last 2 months
- •history of IV bisphosphonate use or oral bisphosphonate use contraindicating dental implant therapy
- •untreated caries or periodontal disease
- •severe bruxism
- •smoker within past 6 months
- •unlikely to be able to comply with study procedures according to investigators
- •known allergy to any materials used in dental implant surgery
Arms & Interventions
abutment margin 0.5 mm subgingival
when fabricating an abutment to support the crown, the margin will be placed 0.5 mm below the gumline
Intervention: abutment margin 0.5 mm subgingival (Device)
abutment margin 1.5 mm subgingival
when fabricating the abutment to support the crown, the margin will be placed 1.5 mm below the gumline
Intervention: abutment margin 1.5 mm subgingival (Device)
Outcomes
Primary Outcomes
Number of Participants With Abutment Margin Exposure > 0
Time Frame: up to 6 months post surgery
Margin exposure of the abutment between groups at 6 months post surgery.
Secondary Outcomes
- Number of Participants With Provisional Crown Fit at Delivery(8 weeks post surgery)
- Number of Participants With a Soft Tissue Response of Bleeding(6 months post surgery)