Digital Eye-assisted bone density guides site drilling for a single dental implant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, single-arm study evaluates a site-specific bone-density classification and software-guided drilling protocol for placing a single dental implant. It uses the R2GATE Digital EYE feature integrated with CBCT and intraoral scans to create a 3D model for prosthetically guided planning. The approach aims to tailor drilling steps to local bone characteristics and to measure immediate implant stability with MEGA ISQ and insertion torque, informing whether the digital workflow enhances primary stability. Eligible participants are adults without systemic contraindications to surgery, with adequate bone at a single edentulous site and favorable periodontal health, who smoke minimally or not at all. The study seeks to determine the clinical applicability of this site-specific approach and its potential impact on implant planning and outcomes.

Why it matters

Who can join: the full rules

Patient recruitment was based on the following inclusion and exclusion criteria:

Inclusion Criteria

Patients were included if they met the following criteria:

1. Age ≥18 years.
2. Absence of systemic conditions contraindicating implant surgery.
3. Non-smokers or light smokers (less than 10 Cig/Day).
4. healthy and stable periodontal tissues.
5. Having a single tooth bounded edentulous area.
6. 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
7. Provision of written informed consent. Exclusion Criteria

Patients were excluded if any of the following conditions were present:

1. Local or systemic infection at the time of implant placement.
2. Metabolic or osseous diseases affecting bone metabolism, including osteoporosis and osteopetrosis.
3. Renal disease, oncologic disease, or disorders affecting calcium metabolism.
4. Benign or malignant pathology involving the maxillary or mandibular bones.
5. Previous implant or prosthetic treatment at the study site.
6. Previous or current bisphosphonate therapy.
7. History of head and neck radiotherapy.
8. Multiple tooth or unbounded edentulous area.
9. Requirement for bone augmentation before or during implant placement.
10. Periodontitis patients.
11. Age \<18 years.

Where it's running

• Jordan University of Science and Technology
  Irbid, Jordan Recruiting

Study contacts

• Study coordinator: Reem Sami Abdel-Hafez, A. Prof of Periodontology
• Email: rsabdelhafez@just.edu.jo
• Phone: 00962799497779

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.