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

Recruiting

• Conditions: Edentulism

• Registration Number: NCT06794138
• Lead Sponsor: Semmelweis University

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.

Study Timeline

• Study First Submitted: 2025-01-21
• Study First Submitted QC: 2025-01-21
• Study First Posted: 2025-01-27
• Status Verified: 2025-03
• Study Start: 2025-03-05
• Last Update Submitted: 2025-03-05
• Last Update Posted: 2025-03-10
• Primary Completion: 2025-04
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Implant survival	5 years	The implant is present at the surgical site without signs of failure, mobility, and pain at the time of the follow-up
Implant success	5 years	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
Success of the implant borne prostheses	5 years	Prostheses with four or fewer complications (screw loosening, decementation, chipping) that could be treated chairside.

Secondary Outcome Measures

Name	Time	Method
Marginal Bone Loss (MBL)	5 years	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.
Implant placement accuracy (Angular deviation)	2 months	Angular deviation of the implant axis between planned and clinically achieved implant positions in degrees.
Peri-implant mucositis	5 years	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
Peri-implantitis	5 years	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.
Biomechanical complications	5 years	The presence or absence of biomechanical complications of the implant-borne prostheses observed during follow-up.; 1. screw loosening; 2. screw fracture; 3. implant fracture; 4. abutment fracture; 5. fracture of the mesostructure; 6. decementation; 7. chipping of the restoration; 8. fracture of the prosthesis; 9. decreased retention reported by the patient due to the wear of the matrices; 10. loss of matrices
Intra-operative complications	at the time of the surgery	1. insufficient space to operate; 2. fracture of the surgical guide; 3. implant placement in an inadequate position; 4. Inadequate fit of the surgical template; 5. Inadequate stability of the surgical template
Implant placement accuracy (Apical Global Deviation)	2 months	The 3D deviation between the planned and the placed implants at the center of the implant apex in mm.
Implant placement accuracy (Coronal Global Deviation)	2 months	The 3D deviation between the planned and the placed implants at the center of the implant platform in mm.

Trial Locations

Locations (1)

Department of Public Dental Health; 🇭🇺 Budapest, Hungary