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

NCT06794138 | Completed DMC

• 1 other identifier: SEDCD56
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Edentulism

Keywords

computer assisted implant surgery; static navigation; dental implant; overdentures; fixed partial dentures; implant placement accuracy

Outcome Measures

Primary Outcomes (3)

• 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

• Success of the implant borne prostheses

  Prostheses with four or fewer complications (screw loosening, decementation, chipping) that could be treated chairside.

  5 years

Secondary Outcomes (8)

• Intra-operative complications

  at the time of the surgery

• Marginal Bone Loss (MBL)

  5 years

• Biomechanical complications

  5 years

• Implant placement accuracy (Apical Global Deviation)

  2 months

• Implant placement accuracy (Coronal Global Deviation)

  2 months

Study Arms (1)

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

Interventions

dental implant placement PROCEDURE

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.

static Computer Assisted Implant Placement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Semmelweis University: lead

Study Sites (1)

Department of Public Dental Health

Budapest, 1088, Hungary

Location

Study Officials

• Márton Kivovics, DMD

  Semmelweis University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: January 21, 2025
• First Posted: January 27, 2025
• Study Start: March 5, 2025
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Immediately after publication, no end date.
• Access Criteria: Anyone who wishes to access the data.

Locations

HU (1)