Fabrication of a Definitive Cad/Cam Titanium Abutment Prior to Guided Surgery: a Pilot Study.

Study Overview
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Brief Summary
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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.

Official Title
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Fabrication of a Definitive Cad/Cam Titanium Abutment Prior to Guided Surgery: a Pilot Study.

Conditions
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Single Edentulous Space

Intervention / Treatment
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* Device: abutment margin 0.5 mm subgingival
* Device: abutment margin 1.5 mm subgingival


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: abutment margin 0.5 mm subgingival<br>when fabricating an abutment to support the crown, the margin will be placed 0.5 mm below the gumline | Device: abutment margin 0.5 mm subgingival<br> <br> |
| Other: abutment margin 1.5 mm subgingival<br>when fabricating the abutment to support the crown, the margin will be placed 1.5 mm below the gumline | Device: abutment margin 1.5 mm subgingival<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Abutment Margin Exposure > 0 | Margin exposure of the abutment between groups at 6 months post surgery. | up to 6 months post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With a Soft Tissue Response of Bleeding | To assess the condition of the peri-implant mucosa, those with a soft tissue response of bleeding upon probing were counted. Fisher's exact test will be used after the site has been evaluated for presence of bleeding or not. | 6 months post surgery | 
| Number of Participants With Provisional Crown Fit at Delivery | To assess if the Provisional Crown was able to be cemented at time of abutment connection was reported as 'Yes' or 'No.' | 8 weeks post surgery |