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

The Success of Implant-borne Prostheses Following Fully-guided Static Computer-assisted Implant Surgery, a Retrospective Study.

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.

Study Overview

• Status: Completed
• Conditions: Edentulism
• Intervention / Treatment: Procedure: dental implant placement

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.

• Study Type: Observational
• Enrollment (Actual): 13

Contacts and Locations

Study Locations

• Hungary
  • Budapest, Hungary, 1088
    • Department of Public Dental Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients of the Department of Public Dental Health, Semmelweis University are included in this study.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

static Computer Assisted Implant Placement; 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.

Procedure: dental implant placement; The fit of the surgical guide was checked and a flapless procedure was performed under local anesthesia. However, in cases where the width of keratinized mucosa was insufficient a limited full-thickness flap was elevated. The surgical template was fixed on the remaining dentition and mucosa using template fixation pins. Fully guided implant bed preparation was performed. Osteotomies were carried out with external cooling at a drill rotation speed of 800 rpm. Implant placement was performed using a manual torque wrench Dental implants were placed non-submerged. In cases of flap elevation, wound margins were stabilized with single interrupted sutures. Sutures were removed at 7 days postop.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success of the implant borne prostheses	Prostheses with four or fewer complications (screw loosening, decementation, chipping) that could be treated chairside.	5 years
Implant survival	The implant is present at the surgical site without signs of failure, mobility, and pain at the time of the follow-up	5 years
Implant success	According to The International Congress of Oral Implantologists (ICOI) Pisa Consensus Conference. Success (optimum health) No pain or tenderness upon function 0 mobility less than 2 mm radiographic bone loss from initial surgery No exudates in the patient's history II. Satisfactory survival No pain on function 0 mobility 2-4 mm radiographic bone loss No exudates in the patient's history III. Compromised survival May have sensitivity on function No mobility Radiographic bone loss of more than 4 mm (less than half of the length of the implant body) Probing depth of more than 7 mm May have exudates in the patient's history IV. Failure (clinical or absolute failure) Any of the following: Pain on function Mobility Radiographic bone loss of more than half length of the implant Uncontrolled exudate Implant no longer in mouth	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intra-operative complications	insufficient space to operate; fracture of the surgical guide; implant placement in an inadequate position; Inadequate fit of the surgical template; Inadequate stability of the surgical template	at the time of the surgery
Marginal Bone Loss (MBL)	MBL is measured on the control panoramic radiographs using ImageJ software (National Institutes of Health, Bethesda, MD, U.S.A.) by calibrating the measurement tool with the known length of the implant. Marginal bone loss was measured as the average value of the distance from the platform of the implant to the most coronal bone-to-implant contact on the mesial and distal aspects of each implant in mm.	5 years
Implant placement accuracy (Apical Global Deviation)	The 3D deviation between the planned and the placed implants at the center of the implant apex in mm.	2 months
Implant placement accuracy (Coronal Global Deviation)	The 3D deviation between the planned and the placed implants at the center of the implant platform in mm.	2 months
Implant placement accuracy (Angular deviation)	Angular deviation of the implant axis between planned and clinically achieved implant positions in degrees.	2 months
Peri-implant mucositis	Presence of peri-implant signs of inflammation (redness, swelling, line or drop of bleeding within 30s following probing) combined with no additional bone loss following initial healing	5 years
Peri-implantitis	Radiographically determined vertical bone loss ≥3 mm in combination with bleeding on probing (BOP) and probing depths (PD) ≥ 6 mm were deemed to indicate peri-implantitis.	5 years
Biomechanical complications	The presence or absence of biomechanical complications of the implant-borne prostheses observed during follow-up.; screw loosening; screw fracture; implant fracture; abutment fracture; fracture of the mesostructure; decementation; chipping of the restoration; fracture of the prosthesis; decreased retention reported by the patient due to the wear of the matrices; loss of matrices	5 years

Collaborators and Investigators

• Sponsor: Semmelweis University
• Investigators: Principal Investigator: Márton Kivovics, DMD, Semmelweis University

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2025
• Primary Completion (Actual): May 1, 2025
• Study Completion (Actual): May 1, 2025

Study Registration Dates

• First Submitted: January 21, 2025
• First Submitted That Met QC Criteria: January 21, 2025
• First Posted (Actual): January 27, 2025

Study Record Updates

• Last Update Posted (Actual): August 1, 2025
• Last Update Submitted That Met QC Criteria: July 29, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: dental implant; fixed partial dentures; computer assisted implant surgery; static navigation; overdentures; implant placement accuracy
• Other Study ID Numbers: SEDCD56

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results published after de-identification.
• IPD Sharing Time Frame: Immediately after publication, no end date.
• IPD Sharing Access Criteria: Anyone who wishes to access the data.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No