The Success of Implant-borne Prostheses Following Fully-guided Static Computer-assisted Implant Surgery.

Last updated: March 5, 2025
Sponsor: Semmelweis University
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

dental implant placement

Clinical Study ID

NCT06794138
SEDCD56
  • Ages > 18
  • All Genders

Study Summary

This study aims to determine the success of implant-borne prostheses and the accuracy of implant placement that can be achieved using fully guided static Computer Assisted Implant Surgery (sCAIS). Additional aims included the evaluation of the stability and health of hard and soft tissues, respectively surrounding the dental implants.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients who received implant-borne prostheses for oral rehabilitation.

  • Patients who had dental implants placed using fully guided sCAIS.

Exclusion

Exclusion Criteria:

  • patients who had major systemic diseases as classified by the American Society ofAnesthesiologists (ASA grades III-IV)

  • psychiatric contraindications

  • patients on medication interfering with bone metabolism, including steroid therapyand antiresorptive medication

  • radiation to the head or neck region within the previous five years

  • localized periapical disease, including odontogenic and nonodontogenic cysts.

  • high and moderate patients with existing occlusal parafunction

  • evidence of uncontrolled periodontal disease

  • Alcohol Use Disorder defined by the Diagnostic and Statistical Manual of MentalDisorders, 5th Edition (DSM-5)

  • recreational drug abuse

  • heavy smoking (>10 cigarettes/day),

  • diseases of the oral mucosa, including blisters and ulcers, red and white lesions,pigmented lesions, benign tumors of the oral cavity, and oral cancer.

  • pregnancy or nursing

  • poor oral hygiene as determined by a modified plaque score >30%

  • unavailability for regular follow-ups.

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: dental implant placement
Phase:
Study Start date:
March 05, 2025
Estimated Completion Date:
June 30, 2025

Study Description

Surgical planning A virtual planning software is used for surgical planning. Cone beam computed tomography (CBCT) reconstruction and intraoral scans are registered. Prosthetic plans are created in the software, or the radiological template was used as one. The angulation and position of the dental implants are determined by the prosthetic plan.

Surgical guides The surgical templates are manufactured by rapid prototyping (3D printing). To guide the drills for implant bed preparation sleeves are inserted in the surgical guides.

Surgical protocol Surgical interventions are performed by a single clinician experienced in dental implant placement and static navigation. Patients rinse with 0.2% chlorhexidine solution for 1 min before surgery. The fit of the surgical guide is checked under local anesthesia. Fully guided implant bed preparation is performed. Dental implants are placed non-submerged. Sutures are removed at 7 days postop. The prosthetic stages of treatment begin after a two-month healing period.

Prosthetic procedures Implant-borne overdentures are manufactured using a hybrid (analog-digital) workflow. An open tray impression is taken using a medium body silicone impression material to capture the position of the implant platforms. An overdenture and a bar mesostructure are manufactured by the dental laboratory with a precision attachment.

Fixed partial dentures (FPD) are manufactured using either a hybrid or a digital workflow. An open tray impression is taken using a medium body silicone impression material or postoperative intraoral scans are performed with scan bodies to capture the position of the implant platforms. Screw or cement-retained porcelain fused to metal FDPs are manufactured by the dental laboratory. Pre-contacts are finished using articulating papers until balanced occlusion in cases of overdentures or lateral guidance in cases of FPDs are obtained. Patients are recalled twice per year for controls and professional dental hygiene intervention.

Connect with a study center

  • Department of Public Dental Health

    Budapest, 1088
    Hungary

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.