EdentulismNCT06794138
The Success of Implant-borne Prostheses Following Fully-guided Static Computer-assisted Implant Surgery.
An observational study of Edentulism, run by Semmelweis University at 1 site in Hungary.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Edentulism
- What is being tested?
- dental implant placement
- Type of treatment
- Surgery or procedure
- How many people
- 13 participants
- Where
- 1 siteHungary
- Study dates
- 5 Mar 2025to 1 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients of the Department of Public Dental Health, Semmelweis University are included in this study.
Who may be able to join
- Patients who received implant-borne prostheses for oral rehabilitation.
- Patients who had dental implants placed using fully guided sCAIS.
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Edentulism
- Being tested
- dental implant placement
- Keywords
- computer assisted implant surgery, static navigation, dental implant, overdentures, fixed partial dentures, implant placement accuracy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dental implant placementProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: dental implant placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant survival
The implant is present at the surgical site without signs of failure, mobility, and pain at the time of the follow-up
Measured: 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
Measured: 5 years
Success of the implant borne prostheses
Prostheses with four or fewer complications (screw loosening, decementation, chipping) that could be treated chairside.
Measured: 5 years
Secondary outcomes (8)
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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 2 months
Implant placement accuracy (Angular deviation)
Angular deviation of the implant axis between planned and clinically achieved implant positions in degrees.
Measured: 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
Measured: 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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start5 Mar 2025
- Primary completion1 May 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EdentulismStudies of the same condition, open and under way.
- More trials run by Semmelweis UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Semmelweis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marton Kivovics, Semmelweis University
- Investigators
- Márton Kivovics, DMD, Principal investigator, Semmelweis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06794138
- Sponsor's protocol ID
- SEDCD56
- Status last verified
- Jul 2025
- First submitted
- 21 Jan 2025
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results published after de-identification.
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Success of Implant-borne Prostheses Following Fully-guided Static Computer-assisted Implant Surgery, a Retrospective Study.
- ClinicalTrials.gov ID
- NCT06794138
- Acronym / sponsor ID
- SEDCD56
- Conditions
- Edentulism
- Keywords
- computer assisted implant surgery, static navigation, dental implant, overdentures, fixed partial dentures, implant placement accuracy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Study start
- 5 Mar 2025 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 27 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| static Computer Assisted Implant Placement | – | Procedure: dental implant placementPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of the Department of Public Dental Health, Semmelweis University are included in this study.
Key inclusion criteria (2 listed)
- Patients who received implant-borne prostheses for oral rehabilitation.
- Patients who had dental implants placed using fully guided sCAIS.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dental implant placementThe 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. | Procedure or surgery | static Computer Assisted Implant Placement |
Primary outcome
Implant survival
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
Implant success
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
Success of the implant borne prostheses
Time frame: 5 years
Prostheses with four or fewer complications (screw loosening, decementation, chipping) that could be treated chairside.
8 secondary outcomes
Intra-operative complications
Time frame: at the time of the surgery
Marginal Bone Loss (MBL)
Time frame: 5 years
Biomechanical complications
Time frame: 5 years
Implant placement accuracy (Apical Global Deviation)
Time frame: 2 months
Implant placement accuracy (Coronal Global Deviation)
Time frame: 2 months
Implant placement accuracy (Angular deviation)
Time frame: 2 months
Peri-implant mucositis
Time frame: 5 years
Peri-implantitis
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results published after de-identification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Márton Kivovics, DMD principal investigator
Semmelweis University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Edentulism, run by Semmelweis University at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant survival (time frame: 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2025.