Clinical trial NCT02218541: Fabrication of a Definitive Cad/Cam Titanium Abutment Prior to Guided Surgery: a Pilot Study.
Official title: Fabrication of a Definitive Cad/Cam Titanium Abutment Prior to Guided Surgery: a Pilot Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Single Edentulous Space
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2014-08-18
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of Participants With Abutment Margin Exposure > 0
timeFrame: up to 6 months post surgery
Secondary outcomes:
measure: Number of Participants With a Soft Tissue Response of Bleeding
timeFrame: 6 months post surgery
measure: Number of Participants With Provisional Crown Fit at Delivery
timeFrame: 8 weeks post surgery
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Graduate Prosthodontic Clinic, Dept. of Prosthodontics, UNC School of Dentistry
state: North Carolina
Study officials:
affiliation: University of North Carolina School of Dentistry
name: Ingeborg De Kok, DDS
role: PRINCIPAL_INVESTIGATOR
References: