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Digital Eye®-Assisted Bone Density Classification and Primary Dental Implant Stability.
Sponsor: King Abdullah University Hospital
Summary
Dental implants are used nowadays to replace extracted teeth. They provide a successful substitute for lost teeth. Accurate planning prior to implant placement is very important. Reduced bone density at the site of dental implant placement can affect the success of dental implants. Thus, accurate evaluation of the density is an important aspect in planning. This prospective, single-arm clinical study investigate the clinical applicability of site-specific bone-density assessment and software-recommended drilling in relation to primary implant stability in adults requiring a single implant in a healed premolar or molar site.
Official title: SITE SPECIFIC DRILLING PROTOCOL BASED ON DIGITAL EYE®-ASSISTED BONE DENSITY CLASSIFICATION AND PRIMARY DENTAL IMPLANT STABILITY. SINGLE- ARM PROSPECTIVE CLINICAL STUDY
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2025-04-01
Completion Date
2027-01-30
Last Updated
2026-10-27
Healthy Volunteers
No
Conditions
Interventions
R2GATE Digital EYE-Assisted Site-Specific Drilling Protocol
Digitally guided implant placement will be planned and performed for thirty bounded edentulous maxillary and thirty mandibular molar healed sites. Pre-operative CBCT Images of the maxillary and mandibular jaws of the recruited patients will be acquired. Images will be obtained in DICOM format and exported to the software for pre-operative digital implant planning. R2GATE® Digital EYE® is used to assess bone density at the planned implant site and generate a site-specific drilling recommendation. The osteotomy is prepared according to the software-recommended drilling sequence, with the use or omission of an optional final drill recorded when applicable. Primary implant stability is measured immediately after placement using insertion torque and resonance frequency analysis, reported as the implant stability quotient (ISQ). A digitally designed surgical guide is used to guide placement of a MegaGen AnyRidge® dental implant.
R2GATE® Digital EYE® Implant Planning Software
R2GATE® Digital EYE® software is used to assess bone density at the planned implant site and generate a site-specific drilling recommendation. Preoperative CBCT images are imported into the software for digital implant planning. The recommended osteotomy drilling sequence is followed during implant placement.
MEGA ISQ® - Implant Stability Measurement Device
The MEGA ISQ® device is used to assess primary dental implant stability immediately after implant placement using resonance frequency analysis (RFA). Measurements are recorded as implant stability quotient (ISQ) values in the specified measurement directions, and the readings are averaged to obtain the mean ISQ for each implant.
Insertion Torque Measurement
A dental implant surgical motor (MEG Engine® II ) with torque measurement is used during implant placement to record insertion torque, expressed in N·cm, as an indicator of primary implant stability. The insertion torque value is recorded for each implant immediately after placement.
UNC-15 Probe Depth Measurement Device
The UNC-15 Probe is used to assess the clinically achieved implant placement depth. The measured clinical depth is recorded and compared with the digitally planned implant depth to evaluate the accuracy of implant placement and the discrepancy between planned and achieved depths.
Locations (1)
Jordan University of Science and Technology
Irbid, Jordan