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

S

Semmelweis University

Status

Completed

Conditions

Edentulism

Treatments

Procedure: dental implant placement

Study type

Observational

Funder types

Other

Identifiers

NCT06794138
SEDCD56

Details and patient eligibility

About

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.

Full 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.

Enrollment

13 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients who received implant-borne prostheses for oral rehabilitation.
  • Patients who had dental implants placed using fully guided sCAIS.

Exclusion criteria

  • patients who had major systemic diseases as classified by the American Society of Anesthesiologists (ASA grades III-IV)
  • psychiatric contraindications
  • patients on medication interfering with bone metabolism, including steroid therapy and 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 Mental Disorders, 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.

Trial design

13 participants in 1 patient group

static Computer Assisted Implant Placement
Description:
Patients who received implant-borne prostheses following fully guided sCAIS at the Department of Public Dental Health, Semmelweis University were included in this retrospective observational study.
Treatment:
Procedure: dental implant placement

Trial contacts and locations

1

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Central trial contact

Dorottya Pénzes, DMD; Márton Kivovics, DMD

Data sourced from clinicaltrials.gov

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