NCT07512258

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).

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
23mo left

Started Aug 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 6, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

June 25, 2026

Status Verified

June 1, 2026

Enrollment Period

11 months

First QC Date

March 30, 2026

Last Update Submit

June 22, 2026

Conditions

Dental Implant

Outcome Measures

Primary Outcomes (3)

  • Implant placement deviation from computerized planning

    Implant placement deviation from computerized planning at 12-month post-placement using CBCT overlay measurement techniques.

    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

    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).

    4 weeks

Study Arms (2)

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.

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

Procedure: Fully Guided (FG)

Interventions

Pilot Drill Guide (PDG)PROCEDURE

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.

Pilot Drill Guide (PDG)
Fully Guided (FG)PROCEDURE

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.

Fully Guided (FG

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294-0007, United States

Location

Study Officials

  • Maria L Geisinger, DDS, MS

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Geisinger, DDS, MS

CONTACT

205-934-4984miagdds@uab.edu

Sarah Startley, DMD

CONTACT

205-975-8711ss1971@uab.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair, Professor

Study Record Dates

First Submitted

March 30, 2026

First Posted

April 6, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2028

Last Updated

June 25, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Data from this study will not be shared with other researchers outside of our research team.

Locations

US(1)