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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorUniversity of Alabama at Birmingham

About this trial

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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

English speaking

At least 18 years old

Must be a patient of the UAB Dental School

Able to read and understand informed consent document

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pilot Drill Guide (PDG)

    Procedure/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/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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Pilot Drill Guide (PDG)Active comparator 1 intervention
Group B: Fully Guided (FGExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Implant placement deviation from computerized planning

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

Time frame
12 months
2

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

Time frame
From baseline to 12 months
3

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).

Time frame
4 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: