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
- Are there results?
- Not yet: the study is under way
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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Two Implant Placement Protocols to Evaluate Placement Accuracy and Post-Operative Healing
- ClinicalTrials.gov ID
- NCT07512258
- Acronym / sponsor ID
- IRB-300016397
- Conditions
- Dental Implant
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 6 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pilot Drill Guide (PDG) | Active comparator | 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. |
| Fully Guided (FG | Experimental | 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 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 or surgery | Pilot Drill Guide (PDG) |
| 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. | Procedure or surgery | Fully Guided (FG |
Primary outcome
Implant placement deviation from computerized planning
Time frame: 12 months
Implant placement deviation from computerized planning at 12-month post-placement using CBCT overlay measurement techniques.
Radiographic marginal bone loss
Time frame: 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
Time frame: 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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No. Data from this study will not be shared with other researchers outside of our research team.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maria L Geisinger, DDS, MS principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria Geisinger, DDS, MS (205-934-4984, miagdds@uab.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant placement deviation from computerized planning (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.