Department of Public Dental Health
Budapest, 1088, Hungary
NCT Number: NCT06794138
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.
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Notify Me18 year and older
All sexes
Observational
Budapest, 1088, Hungary
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 5 years
The implant is present at the surgical site without signs of failure, mobility, and pain at the time of the follow-up
Time frame: 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
Time frame: 5 years
Prostheses with four or fewer complications (screw loosening, decementation, chipping) that could be treated chairside.
Time frame: at the time of the surgery
Time frame: 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.
Time frame: 5 years
The presence or absence of biomechanical complications of the implant-borne prostheses observed during follow-up.
Time frame: 2 months
The 3D deviation between the planned and the placed implants at the center of the implant apex in mm.
Time frame: 2 months
The 3D deviation between the planned and the placed implants at the center of the implant platform in mm.
Time frame: 2 months
Angular deviation of the implant axis between planned and clinically achieved implant positions in degrees.
Time frame: 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
Time frame: 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.
Semmelweis University
Other
The Success of Implant-borne Prostheses Following Fully-guided Static Computer-assisted Implant Surgery, a Retrospective Study.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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