To Compare the Two Implant Placement Protocols to Evaluate Placement Accuracy and Post-operative Healing of the Implant
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pilot Drill Guide (PDG), Fully Guided (FG).
- Who it may be relevant to
- Registry conditions: Dental Implant. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Assessment of Two Implant Placement Protocols to Evaluate Placement Accuracy and Post-Operative Healing
Overview
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
- Procedure Pilot 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. - Procedure Fully 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.
Primary outcome measures
- Implant placement deviation from computerized planning [Time frame: 12 months]
- Radiographic marginal bone loss [Time frame: From baseline to 12 months]
- Patient centered outcomes using the Visual Analog Scale (VAS [Time frame: 4 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Alabama at Birmingham — Birmingham
Identifiers
NCT: NCT07512258 · IRB-300016397 · UAB Periodontology