Clinical trial NCT06794138: The Success of Implant-borne Prostheses Following Fully-guided Static Computer-assisted Implant Surgery.
Official title: The Success of Implant-borne Prostheses Following Fully-guided Static Computer-assisted Implant Surgery, a Retrospective Study.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Edentulism
Keywords: computer assisted implant surgery
static navigation
dental implant
overdentures
fixed partial dentures
implant placement accuracy
Lead sponsor: Semmelweis University
Sponsor class: OTHER
First posted: 2025-01-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of the Department of Public Dental Health, Semmelweis University are included in this study.

Brief 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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Implant survival
timeFrame: 5 years
measure: Implant success
timeFrame: 5 years
measure: Success of the implant borne prostheses
timeFrame: 5 years
Secondary outcomes:
measure: Intra-operative complications
timeFrame: at the time of the surgery
measure: Marginal Bone Loss (MBL)
timeFrame: 5 years
measure: Biomechanical complications
timeFrame: 5 years
measure: Implant placement accuracy (Apical Global Deviation)
timeFrame: 2 months
measure: Implant placement accuracy (Coronal Global Deviation)
timeFrame: 2 months
measure: Implant placement accuracy (Angular deviation)
timeFrame: 2 months
measure: Peri-implant mucositis
timeFrame: 5 years
measure: Peri-implantitis
timeFrame: 5 years
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Department of Public Dental Health
Study officials:
affiliation: Semmelweis University
name: Márton Kivovics, DMD
role: PRINCIPAL_INVESTIGATOR
References: