N/A
N=22
Fabrication of a Definitive Cad/Cam Titanium Abutment Prior to Guided Surgery: a Pilot Study.
Single Edentulous Space
Bottom Line
View on ClinicalTrials.gov: NCT02218541 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Jul 2018
Primary outcome: Primary: Number of Participants With Abutment Margin Exposure > 0 — 0; 0 Participants — p=1.00
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- abutment margin 0.5 mm subgingival (Device); abutment margin 1.5 mm subgingival (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Abutment Margin Exposure > 0 |
0; 0 | 1.00 |
| SECONDARY Number of Participants With a Soft Tissue Response of Bleeding |
3; 8; 2; 1 | 0.039 sig |
| SECONDARY Number of Participants With Provisional Crown Fit at Delivery |
3; 5; 2; 4 | 1.0 |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02218541). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.