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NCT Number: NCT07512258

To Compare the Two Implant Placement Protocols to Evaluate Placement Accuracy and Post-operative Healing of the Implant

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).

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Key information

Conditions

Dental Implant

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

  2. 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

  3. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Maria Geisinger, DDS, MS

CONTACT

[email protected]

205-934-4984

Sarah Startley, DMD

CONTACT

[email protected]

205-975-8711

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

Assessment of Two Implant Placement Protocols to Evaluate Placement Accuracy and Post-Operative Healing

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Apr 6, 2026
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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