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Trial · NCT07899606

Digital Eye®-Assisted Bone Density Classification and Primary Dental Implant Stability.

NCT07899606, Not applicable, Recruiting, King Abdullah University Hospital

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Digital Eye®-Assisted Bone Density Classification and Primary Dental Implant Stability. Trials, record NCT07899606. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07899606

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Digital Eye®-Assisted Bone Density Classification and Primary Dental Implant Stability.
NCT number
NCT07899606
Status
Recruiting
Phases
Not applicable
Enrollment
60 participants, estimated
Lead sponsor
King Abdullah University Hospital
Conditions
Bone Mineral Density, Primary Implant Stability, Digital Eye Bone Density Assessment, Site-specific Drilling Protocol
Interventions
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
First posted
2026-10-27
Last updated
2026-10-27

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryResulted Insertion torque according to R2GATE Digital EYE bone-density classification and its site specific drilling protocol.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.
PrimaryMean implant stability quotient (ISQ) according to R2GATE Digital EYE bone-density classification and its site specific drilling protocol.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.
SecondaryAgreement between R2GATE Digital EYE and ACTEON Imaging Suite bone-density classificationsDuring preoperative digital implant planning, before implant placement.
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.
SecondaryAssessment of the primary stability according to implant diameter (4.0 mm versus 4.5 mm)At final implant seating and immediately after implant placement (postoperative)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.
SecondaryImplant placement depth accuracy with sleeved and sleeveless surgical guidesAt the preoperative digital plan and clinical measurements recorded immediately after placement at final implant seating (postoperative).
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.
SecondaryAgreement between digitally planned and clinically achieved implant depthAt implant placement, comparing the preoperative digital plan with clinical measurements recorded immediately after placement (postoperative).
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.
SecondaryCorrelation between insertion torque and mean implant stability quotientDuring implant placement and immediately after placement, when insertion torque and ISQ measurements are obtained, respectively when the implant reached its planned position (postoperative).
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.

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT07899606

GET https://conductscience.org/api/trials/v1/NCT07899606/registered