Bone Mineral DensityNCT07899606
Digital Eye®-Assisted Bone Density Classification and Primary Dental Implant Stability.
A study testing R2GATE Digital EYE-Assisted Site-Specific Drilling Protocol, R2GATE® Digital EYE® Implant Planning Software and MEGA ISQ® - Implant Stability Measurement Device in people with Bone Mineral Density and Primary Implant Stability, run by King Abdullah University Hospital at 1 site in Jordan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Mineral Density, Primary Implant Stability, Digital Eye Bone Density Assessment
- What is being tested?
- R2GATE Digital EYE-Assisted Site-Specific Drilling Protocol, R2GATE® Digital EYE® Implant Planning Software and MEGA ISQ® - Implant Stability Measurement Device
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteJordan
- Study dates
- 1 Apr 2025to 30 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients were included if they met the following criteria:
- Age ≥18 years.
- Absence of systemic conditions contraindicating implant surgery.
- Non-smokers or light smokers (less than 10 Cig/Day).
- healthy and stable periodontal tissues.
- Having a single tooth bounded edentulous area.
Show all 20Show fewer
- Availability of sufficient bone height and width to allow implant placement without the need for simultaneous or staged bone augmentation procedures as evaluated on CBCT
- Provision of written informed consent. Exclusion Criteria
- Patients were excluded if any of the following conditions were present:
- Local or systemic infection at the time of implant placement.
- Metabolic or osseous diseases affecting bone metabolism, including osteoporosis and osteopetrosis.
- Renal disease, oncologic disease, or disorders affecting calcium metabolism.
- Benign or malignant pathology involving the maxillary or mandibular bones.
- Previous implant or prosthetic treatment at the study site.
- Previous or current bisphosphonate therapy.
- History of head and neck radiotherapy.
- Multiple tooth or unbounded edentulous area.
- Requirement for bone augmentation before or during implant placement.
- Periodontitis patients.
- Age <18 years.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jordan1 site, 1 recruiting
- Recruiting
Jordan University of Science and Technology
Irbid
Reem Abdel-Hafez, MSc (Clin) Periodontology, 00962799497779, rsabelhafez@just.edu.jo
Hana Rahhal, MClinDent in Periodontology
About this study
Official title: SITE SPECIFIC DRILLING PROTOCOL BASED ON DIGITAL EYE®-ASSISTED BONE DENSITY CLASSIFICATION AND PRIMARY DENTAL IMPLANT STABILITY. SINGLE- ARM PROSPECTIVE CLINICAL STUDY
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.
Read the detailed description
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.
- Conditions
- Bone Mineral Density, Primary Implant Stability, Digital Eye Bone Density Assessment, Site-specific Drilling Protocol
- Being tested
- R2GATE Digital EYE-Assisted Site-Specific Drilling Protocol, R2GATE® Digital EYE® Implant Planning Software, MEGA ISQ® - Implant Stability Measurement Device, Insertion Torque Measurement, UNC-15 Probe Depth Measurement Device
- Keywords
- Bone Mineral Density, Dental implants, Validity, Cone Beam CT, Primary implant stability, Insertion torque, Resonance frequency analysis, Computer-guided implant surgery, ISQ, Site-specific drilling protocol, R2GATE, Digital Eye
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
R2GATE Digital EYE-Assisted Site-Specific Drilling ProtocolProcedure or surgery
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 SoftwareDevice
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 DeviceDevice
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 MeasurementDevice
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 DeviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| R2GATE Digital EYE-Guided Implant Placement | Experimental | 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Immediately after implant placement , when the implant reached its planned position (postoperative)
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: During implant placement and immediately after placement, when insertion torque and ISQ measurements are obtained, respectively when the implant reached its planned position (postoperative).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start1 Apr 2025
- Primary completion30 Jan 2027 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Mineral DensityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single- arm study in which all participants undergo digitally guided dental implant placement using the R2GATE® Digital EYE®-assisted, site-specific bone-density assessment and software-recommended drilling workflow. Preoperative cone-beam computed tomography (CBCT) images and digital intraoral scans are integrated for implant planning. The software-generated drilling recommendation guides site preparation, while the use or omission of an optional 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).
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Abdullah University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reem Abdel-Hafez, King Abdullah University Hospital
- Investigators
- Reem Sami Abdel-Hafez, Study chair, Jordan University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07899606
- Sponsor's protocol ID
- 804-2024
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SITE SPECIFIC DRILLING PROTOCOL BASED ON DIGITAL EYE®-ASSISTED BONE DENSITY CLASSIFICATION AND PRIMARY DENTAL IMPLANT STABILITY. SINGLE- ARM PROSPECTIVE CLINICAL STUDY
- ClinicalTrials.gov ID
- NCT07899606
- Acronym / sponsor ID
- 804-2024
- Conditions
- Bone Mineral Density, Primary Implant Stability, Digital Eye Bone Density Assessment, Site-specific Drilling Protocol
- Keywords
- Bone Mineral Density, Dental implants, Validity, Cone Beam CT, Primary implant stability, Insertion torque, Resonance frequency analysis, Computer-guided implant surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- King Abdullah University HospitalUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 27 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single- arm study in which all participants undergo digitally guided dental implant placement using the R2GATE® Digital EYE®-assisted, site-specific bone-density assessment and software-recommended drilling workflow. Preoperative cone-beam computed tomography (CBCT) images and digital intraoral scans are integrated for implant planning. The software-generated drilling recommendation guides site preparation, while the use or omission of an optional 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).
| Arm | Type | Receives |
|---|---|---|
| R2GATE Digital EYE-Guided Implant Placement | Experimental | 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 DeviceAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Age ≥18 years.
- Absence of systemic conditions contraindicating implant surgery.
- Non-smokers or light smokers (less than 10 Cig/Day).
- healthy and stable periodontal tissues.
- Having a single tooth bounded edentulous area.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| R2GATE Digital EYE-Assisted Site-Specific Drilling ProtocolDigitally 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. | Procedure or surgery | R2GATE Digital EYE-Guided Implant Placement |
| R2GATE® Digital EYE® Implant Planning SoftwareR2GATE® 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. | Device | R2GATE Digital EYE-Guided Implant Placement |
| MEGA ISQ® - Implant Stability Measurement DeviceThe 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. | Device | R2GATE Digital EYE-Guided Implant Placement |
| Insertion Torque MeasurementA 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. | Device | R2GATE Digital EYE-Guided Implant Placement |
| UNC-15 Probe Depth Measurement DeviceThe 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. | Device | R2GATE Digital EYE-Guided Implant Placement |
Primary outcome
Resulted Insertion torque according to R2GATE Digital EYE bone-density classification and its site specific drilling protocol.
Time frame: At the time of final implant seating, when the implant reached its planned position (postoperative)
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.
Mean implant stability quotient (ISQ) according to R2GATE Digital EYE bone-density classification and its site specific drilling protocol.
Time frame: Immediately after implant placement , when the implant reached its planned position (postoperative)
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.
5 secondary outcomes
Agreement between R2GATE Digital EYE and ACTEON Imaging Suite bone-density classifications
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)
Time frame: At final implant seating and immediately after implant placement (postoperative)
Implant placement depth accuracy with 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
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
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Reem Sami Abdel-Hafez study chair
Jordan University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing R2GATE Digital EYE-Assisted Site-Specific Drilling Protocol, R2GATE® Digital EYE® Implant Planning Software and MEGA ISQ® - Implant Stability Measurement Device in people with Bone Mineral Density and Primary Implant Stability, run by King Abdullah University Hospital at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Reem Sami Abdel-Hafez, A. Prof of Periodontology (00962799497779, rsabdelhafez@just.edu.jo), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resulted Insertion torque according to R2GATE Digital EYE bone-density classification and its site specific drilling protocol. (time frame: At the time of final implant seating, when the implant reached its planned position (postoperative)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.