Dental Implant
Conditions
Brief summary
The goal of this study is to evaluate two commonly utilized surgical guide protocols to determine dental implant placement accuracy compared to pre-operative computerized planning, post-operative healing and bone levels to 12-months post-placement, and patient assessed post-operative discomfort and healing using a visual acuity scale (VAS).
Detailed description
This proposed study would allow us to assess the use of two intraoperative surgical guide protocols in common use in dental practice (matrix-based pilot drill guided and fully digital guided) for implant placement surgical procedure.
Interventions
PROCEDUREPilot Drill Guide (PDG)
Matrix-based pilot drill guides fabricated using casts derived from digital wax ups of the proposed final restoration based upon initial implant planning and will be placed using the standard manufacturer's protocol.
PROCEDUREFully Guided (FG)
3-D printed guides fabricated based upon digital wax ups and will be placed using the standard manufacturer's protocol and guided implant placement kits.
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* English speaking * At least 18 years old * Must be a patient of the UAB Dental School * Able to read and understand informed consent document * Patients presenting with a single edentulous site planned for dental implant placement * Presence of periodontally healthy, non-carious neighboring teeth and/or healthy restored dental implants on either side of edentulous site planned for dental implant placement. * No anticipated need for surgical and/or endodontic care at teeth adjacent to the proposed surgical site during the study period.
Exclusion criteria
* Non-English speaking * Less than 18 years old * Smokers/tobacco users (\>10 cigarettes/day) * Patients with systemic pathologies or conditions contraindicating oral surgical procedures or adversely affecting wound healing * Absence of adjacent teeth/implants on either side of the tooth to be extracted and/or edentulous sites where 2 or more adjacent implants are planned.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Implant placement deviation from computerized planning | 12 months | Implant placement deviation from computerized planning at 12-month post-placement using CBCT overlay measurement techniques. |
| Radiographic marginal bone loss | From baseline to 12 months | Radiographic marginal bone loss as measured using digital measurement tools and calibrated parallel two-dimensional radiographic images from baseline dental implant placement to 12-months post-implant placement |
| Patient centered outcomes using the Visual Analog Scale (VAS | 4 weeks | Patient centered outcomes including pain, bleeding, swelling, change in daily activities at 7, 14, and 30 days postoperatively, using the Visual Analog Scale (VAS) This measurement ranges from 0-10 (0 being better and 10 being worse). |
Countries
United States
Contacts
CONTACTMaria Geisinger, DDS, MS
CONTACTSarah Startley, DMD
PRINCIPAL_INVESTIGATORMaria L Geisinger, DDS, MS
University of Alabama at Birmingham
Outcome results
None listed