An interventional study of R2GATE Digital EYE-Assisted Site-Specific Drilling Protocol and R2GATE® Digital EYE® Implant Planning Software in Bone Mineral Density, Primary Implant Stability and Digital Eye Bone Density Assessment, sponsored by King Abdullah University Hospital. Recruiting at 1 site in Jordan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by King Abdullah University Hospital · Not applicable, Interventional, and Other
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.
Primary stability is the mechanical fixation of a dental implant in the surrounding bone immediately after placement. It is influenced by several factors, including local bone characteristics, implant design, and the preparation of the implant site. Conventional bone classification systems describe bone quality broadly and may not fully represent variations in bone characteristics within the specific area intended to receive an implant. An assessment that focuses more closely on the planned implant site may therefore provide additional information for individualized surgical planning.
The R2GATE® Digital EYE® feature provides a color-coded representation of bone characteristics on cone-beam computed tomography (CBCT) images. In this study, a site-specific classification was developed based on the distribution of the software-generated colors in the bone surrounding the virtually planned implant. This classification was used to guide the application of the software-recommended drilling protocol. The recommended drilling sequence may be fully mandatory or may include an optional final drill, allowing the protocol to account for the software recommendation and the clinical drilling sequence used during surgery.
The digital workflow integrates CBCT data with digital intraoral scans to create a three-dimensional model for prosthetically guided implant planning. The planned implant position is assessed in relation to the intended restoration and relevant anatomical structures, and a surgical guide is designed to transfer the digital plan to the clinical setting. The R2GATE® Digital EYE® software is used to assess bone density at the planned implant site and generate a site-specific drilling protocol. Primary implant stability is measured immediately after placement using insertion torque and resonance frequency analysis, reported as the implant stability quotient (ISQ).
The study aims to investigate the clinical applicability of site-specific bone-density assessment and software-recommended drilling in relation to primary implant stability and implant placement accuracy. There is no randomized comparison group. The study also assesses the agreement between bone-density classifications generated by R2GATE® and ACTEON® Imaging Suite, examines the relationship between implant diameter and primary stability, and evaluates the accuracy of implant depth transfer from digital planning to surgery using sleeved and sleeveless surgical guides.
The findings may help inform future research into individualized implant site preparation. The proposed classification and software-recommended drilling approach should not be considered independently validated, and the study does not establish their effects on long-term implant survival or success.
King Abdullah University Hospital is the lead sponsor of 55 studies on the registry; 22 are open to participants now.
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Patient recruitment was based on the following inclusion and exclusion criteria:
Inclusion Criteria
Patients were included if they met the following criteria:
Patients were excluded if any of the following conditions were present:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All participants undergo digitally guided dental implant placement using a site-specific drilling protocol based on bone-density assessment with R2GATE® Digital EYE®. The software generates a recommended drilling sequence for the planned implant site. The final drill is recorded. Primary implant stability is measured immediately after placement using insertion torque and resonance frequency analysis, reported as the implant stability quotient (ISQ). Implant placement is performed using a digitally planned surgical guide.
Procedure: R2GATE Digital EYE-Assisted Site-Specific Drilling Protocol · Device: R2GATE® Digital EYE® Implant Planning Software · Device: MEGA ISQ® - Implant Stability Measurement Device · Device: Insertion Torque Measurement · Device: UNC-15 Probe Depth Measurement Device
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® 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.
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.
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.
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.
Resulted Insertion torque according to R2GATE Digital EYE bone-density classification and its site specific drilling protocol.
Insertion torque is the maximum torque recorded by the implant motor during implant insertion, expressed in Ncm. Values will be summarized and evaluated in relation to the R2GATE® Digital EYE® site-specific bone-density categories and the software-recommended drilling protocol and clinical drilling sequence.
Time frame: At the time of final implant seating, when the implant reached its planned position (postoperative)
Mean implant stability quotient (ISQ) according to R2GATE Digital EYE bone-density classification and its site specific drilling protocol.
Primary implant stability is assessed using resonance frequency analysis (RFA). Five directional ISQ readings are obtained for each implant from the mesial, distal, occlusal, lingual/palatal, and buccal directions. The mean of these five readings is calculated for each implant and evaluated in relation to the R2GATE® Digital EYE® site-specific bone-density categories and the software-recommended drilling protocol and clinical drilling sequence.
Time frame: Immediately after implant placement , when the implant reached its planned position (postoperative)
Agreement between R2GATE Digital EYE and ACTEON Imaging Suite bone-density classifications
Agreement between the site-specific bone-density classifications obtained using R2GATE® Digital EYE® and ACTEON® Imaging Suite will be assessed using the percentage of exact agreement and linearly weighted Cohen's kappa with a 95% confidence interval.
Time frame: During preoperative digital implant planning, before implant placement.
Assessment of the primary stability according to implant diameter (4.0 mm versus 4.5 mm)
Insertion torque, expressed in Ncm, and mean ISQ, calculated from five directional resonance frequency measurements per implant, will be compared between implants with diameters of 4.0 mm and 4.5 mm.
Time frame: At final implant seating and immediately after implant placement (postoperative)
Implant placement depth accuracy with sleeved and sleeveless surgical guides
The absolute difference, in millimeters, between the digitally planned and clinically achieved crest-to-implant-platform distances will be calculated at the mid-buccal and mid-lingual/palatal aspects. Absolute depth deviations will be compared between implants placed using sleeved and sleeveless surgical guides.
Time frame: At the preoperative digital plan and clinical measurements recorded immediately after placement at final implant seating (postoperative).
Agreement between digitally planned and clinically achieved implant depth
The discrepancy between the clinically achieved and digitally planned crest-to-implant-platform distances will be assessed in millimeters at the mid-buccal and mid-lingual/palatal aspects. Agreement will be evaluated using the mean bias and 95% limits of agreement from Bland-Altman analysis, with paired comparisons of planned and achieved measurements.
Time frame: At implant placement, comparing the preoperative digital plan with clinical measurements recorded immediately after placement (postoperative).
Correlation between insertion torque and mean implant stability quotient
The association between insertion torque, expressed in Ncm, and mean ISQ, calculated from five directional resonance frequency measurements per implant, will be assessed using Spearman's rank correlation coefficient.
Time frame: During implant placement and immediately after placement, when insertion torque and ISQ measurements are obtained, respectively when the implant reached its planned position (postoperative).
Plan to share: No — There is currently no plan to make individual participant data (IPD), including data dictionaries, available to other researchers. Participant confidentiality and the ethical requirements governing the use of clinical and radiographic data will be maintained. Study findings will be reported in scientific publications.
No publications or documents are linked to this record.
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King Abdullah University Hospital