Evaluating the success of dental implants using computer-assisted surgery
The Success of Implant-borne Prostheses Following Fully-guided Static Computer-assisted Implant Surgery, a Retrospective Study.
This study is testing if using computer-assisted surgery makes dental implants more successful and helps keep the surrounding teeth and gums healthy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Semmelweis University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Budapest) |
| Trial ID | NCT06794138 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the success rates of implant-borne prostheses and the accuracy of implant placements achieved through fully guided static Computer Assisted Implant Surgery (sCAIS). It utilizes virtual planning software and cone beam computed tomography (CBCT) for precise surgical planning, followed by the creation of 3D printed surgical guides for accurate implant placement. The study also evaluates the stability and health of the surrounding hard and soft tissues post-implantation. Surgical procedures are performed by an experienced clinician, with a focus on ensuring optimal outcomes for patients receiving dental implants.
Who should consider this trial
Good fit: Ideal candidates include patients who require oral rehabilitation through implant-borne prostheses and have undergone implant placement using fully guided sCAIS.
Not a fit: Patients with major systemic diseases, psychiatric contraindications, or those on medications affecting bone metabolism may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the effectiveness and reliability of dental implant procedures, leading to improved patient outcomes.
How similar studies have performed: Previous studies have shown promising results with computer-assisted implant surgery, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Budapest
- Department of Public Dental Health — Budapest, Hungary (Recruiting)
Study contacts
- Principal investigator: Márton Kivovics, DMD — Semmelweis University
- Study coordinator: Márton Kivovics, DMD
- Email: kivovics.marton@semmelweis.hu
- Phone: 00361459051500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.