Dental ImplantNCT07512258
To Compare the Two Implant Placement Protocols to Evaluate Placement Accuracy and Post-operative Healing of the Implant
A study testing Pilot Drill Guide (PDG) and Fully Guided (FG) in people with Dental Implant, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Implant
- What is being tested?
- Pilot Drill Guide (PDG) and Fully Guided (FG)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2026to Jul 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294-0007
Maria Geisinger, DDS, MS, 205-934-4984, miagdds@uab.edu
Sarah Startley, DMD, 205-975-8711, ss1971@uab.edu
About this study
Official title: Assessment of Two Implant Placement Protocols to Evaluate Placement Accuracy and Post-Operative Healing
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).
Read the 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.
- Conditions
- Dental Implant
- Being tested
- Pilot Drill Guide (PDG), Fully Guided (FG)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilot Drill Guide (PDG)Procedure or surgery
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.
Fully Guided (FG)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Pilot Drill Guide (PDG) | Active comparator | 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. Receives: Procedure: Pilot Drill Guide (PDG) |
| Fully Guided (FG | Experimental | 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 Receives: Procedure: Fully Guided (FG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant placement deviation from computerized planning
Implant placement deviation from computerized planning at 12-month post-placement using CBCT overlay measurement techniques.
Measured: 12 months
Radiographic marginal bone loss
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
Measured: From baseline to 12 months
Patient centered outcomes using the Visual Analog Scale (VAS
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).
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study startDec 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria L. Geisinger, DDS, MS, University of Alabama at Birmingham
- Investigators
- Maria L Geisinger, DDS, MS, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07512258
- Sponsor's protocol ID
- IRB-300016397
- Other IDs
- UAB Periodontology
- Status last verified
- Sep 2026
- First submitted
- 30 Mar 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data from this study will not be shared with other researchers outside of our research team.