Partial-edentulismPhase 4NCT04854239
Accuracy of Half-guided Implant Placement
A Phase 4 study testing Half-guided implant placement in people with Partial-edentulism, run by Semmelweis University at 1 site in Hungary.
Trial summary
The aim of the present prospective randomized controlled study is to compare the accuracy of implant placement performed either with a surgical motor or a torque wrench as part of a half-guided surgical protocol after maxillary sinus floor augmentation. Read more about this study
- Who is it for?
- Ages 29 to 67 yearsHealthy volunteers can take part
- Conditions the study is for
- Partial-edentulism
- What is being tested?
- Half-guided implant placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteHungary
- Study dates
- 1 Jan 2017to 31 Jan 2019
- Phase
- Phase 4
- 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 29 to 67 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- at least one edentulous maxillary premolar or molar site treated successfully by sinus floor elevation with a xenogenic bone substitute (cerabone, botiss biomaterials, Zossen, Germany) confirmed by preoperative cone-beam computed tomography
- full- mouth plaque and bleeding scores (FMPS and FMBS) <20%
- good patient compliance (including willingness to participate in the follow-up procedures)
- signed informed consent
Who cannot join
- clinically relevant diseases (e.g.: diabetes, rheumatism, cancer)
- systemic steroid or bisphosphonate use
- acute or chronic inflammatory processes
Trial locations and contacts
1 site in 1 country.
Hungary1 site
Semmelweis University Department of Periodontology
Budapest, 1088
About this study
Official title: Accuracy of Half-guided Implant Placement With Machine-driven or Manual Insertion: a Prospective, Randomized Clinical Study
The aim of the present prospective randomized controlled study is to compare the accuracy of implant placement performed either with a surgical motor or a torque wrench as part of a half-guided surgical protocol after maxillary sinus floor augmentation.
Read the detailed description
Implant insertion with half-guided surgical protocol was utilized by surgical motor (machine-driven group) or torque wrench (manual group) in the maxilla. Forty patients were randomly divided in two study groups; 20 implants were inserted with a surgical motor and 20 implants with a torque wrench. After the healing period, accuracy comparison method between planned and actual implant positions was performed based on digital intraoral scan. Coronal, apical and angular deviation parameters, insertion time and maximum insertion torque was evaluated.
- Conditions
- Partial-edentulism
- Being tested
- Half-guided implant placement
- Keywords
- dental implants, computer-assisted surgery, guided surgery, accuracy, machine driven implant insertion, manual implant insertion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Half-guided implant placementProcedure or surgery
Also called Guided implant placement
The surgery was performed under local anaesthesia in both groups, half-guided implant placement was carried out based on randomization.
| Study group | Role | What they receive |
|---|---|---|
| Machine-driven group | Experimental | In the machine-driven group, after guided implant bed preparation, implant insertion was performed with contra-angled handpiece. Receives: Procedure: Half-guided implant placement |
| Manual group | Experimental | In the manual group, after guided implant bed preparation, implant insertion was performed with torque-wrench. Receives: Procedure: Half-guided implant placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global coronal implant position deviation
Measurement: comparison of planned and actual implant position in a virtual model. Tool: Linear measurement with Amira 5.4.0 (Thermo Fisher Scientific, USA). Unit: mm
Measured: 3 months after implant placement
Global apical implant position deviation
Measurement: comparison of planned and actual implant position in a virtual model. Tool: Linear measurement with Amira 5.4.0 (Thermo Fisher Scientific, USA). Unit: mm
Measured: 3 months after implant placement
Horizontal coronal implant position deviation
Measurement: comparison of planned and actual implant position in a virtual model. Tool: Linear measurement with Amira 5.4.0 (Thermo Fisher Scientific, USA). Unit: mm
Measured: 3 months after implant placement
Horizontal apical implant position deviation
Measurement: comparison of planned and actual implant position in a virtual model. Tool: Linear measurement with Amira 5.4.0 (Thermo Fisher Scientific, USA). Unit: mm
Measured: 3 months after implant placement
Angular implant position deviation
Measurement: comparison of planned and actual implant position in a virtual model. Tool: Linear measurement with Amira 5.4.0 (Thermo Fisher Scientific, USA). Unit: mm
Measured: 3 months after implant placement
Secondary outcomes (3)
Implant insertion torque
Measurement: Insertion torque. Tool: torque wrech Unit: Ncm
Measured: During implant insertion
Implant insertion torque
Measurement: Insertion torque. Tool: surgical motor Unit: Ncm
Measured: During implant insertion
Duration of implant insertion
Measurement: Duration of implant insertion Tool: stopwatch Unit: seconds
Measured: During implant insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study start1 Jan 2017
- Primary completion31 Jan 2019
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Partial-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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Forty patients were treated; implant insertion with half-guided surgical protocol was utilized by surgical motor (20 patients, machine-driven group) or torque wrench (20 patients, manual group) in the maxilla.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Semmelweis University
- Sponsor type
- University, hospital or other
- Collaborators
- NSK Europe GmbH, Botiss Medical AG, Institut Straumann AG, Dicomlab Kft., Hungarian Human Resources Development Operational Program (EFOP-3.6.2-16-2017-00006), Excellence Program of the Ministry for Innovation and Technology in Hungary
- Responsible party
- Principal investigator, Balint Molnar, Semmelweis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04854239
- Sponsor's protocol ID
- Accuracy-Semmelweis-Perio
- Status last verified
- Apr 2021
- First submitted
- 9 Apr 2021
- Last updated
- 22 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Orban K, Varga E Jr, Windisch P, Braunitzer G, Molnar B. Accuracy of half-guided implant placement with machine-driven or manual insertion: a prospective, randomized clinical study. Clin Oral Investig. 2022 Jan;26(1):1035-1043. doi: 10.1007/s00784-021-04087-0. Epub 2021 Aug 16.
PubMed 34401946
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Half-guided Implant Placement With Machine-driven or Manual Insertion: a Prospective, Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT04854239
- Acronym / sponsor ID
- Accuracy-Semmelweis-Perio
- Conditions
- Partial-edentulism
- Keywords
- dental implants, computer-assisted surgery, guided surgery, accuracy, machine driven implant insertion, manual implant insertion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Collaborators
- NSK Europe GmbH, Botiss Medical AG, Institut Straumann AG, Dicomlab Kft., Hungarian Human Resources Development Operational Program (EFOP-3.6.2-16-2017-00006), Excellence Program of the Ministry for Innovation and Technology in Hungary
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 22 Apr 2021 (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.
The aim of the present prospective randomized controlled study is to compare the accuracy of implant placement performed either with a surgical motor or a torque wrench as part of a half-guided surgical protocol after maxillary sinus floor augmentation.
Detailed description
Implant insertion with half-guided surgical protocol was utilized by surgical motor (machine-driven group) or torque wrench (manual group) in the maxilla. Forty patients were randomly divided in two study groups; 20 implants were inserted with a surgical motor and 20 implants with a torque wrench. After the healing period, accuracy comparison method between planned and actual implant positions was performed based on digital intraoral scan. Coronal, apical and angular deviation parameters, insertion time and maximum insertion torque was evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Forty patients were treated; implant insertion with half-guided surgical protocol was utilized by surgical motor (20 patients, machine-driven group) or torque wrench (20 patients, manual group) in the maxilla.
| Arm | Type | Receives |
|---|---|---|
| Machine-driven group | Experimental | Procedure: Half-guided implant placementIn the machine-driven group, after guided implant bed preparation, implant insertion was performed with contra-angled handpiece. |
| Manual group | Experimental | Procedure: Half-guided implant placementIn the manual group, after guided implant bed preparation, implant insertion was performed with torque-wrench. |
Who may qualify
- Ages
- 29 to 67 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- at least one edentulous maxillary premolar or molar site treated successfully by sinus floor elevation with a xenogenic bone substitute (cerabone, botiss biomaterials, Zossen, Germany) confirmed by preoperative cone-beam computed tomography
- full- mouth plaque and bleeding scores (FMPS and FMBS) <20%
- good patient compliance (including willingness to participate in the follow-up procedures)
- signed informed consent
Key exclusion criteria (3 listed)
- clinically relevant diseases (e.g.: diabetes, rheumatism, cancer)
- systemic steroid or bisphosphonate use
- acute or chronic inflammatory processes
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 |
|---|---|---|
| Half-guided implant placementAlso: Guided implant placementThe surgery was performed under local anaesthesia in both groups, half-guided implant placement was carried out based on randomization. | Procedure or surgery | Machine-driven group, Manual group |
Primary outcome
Global coronal implant position deviation
Time frame: 3 months after implant placement
Measurement: comparison of planned and actual implant position in a virtual model. Tool: Linear measurement with Amira 5.4.0 (Thermo Fisher Scientific, USA). Unit: mm
Global apical implant position deviation
Time frame: 3 months after implant placement
Measurement: comparison of planned and actual implant position in a virtual model. Tool: Linear measurement with Amira 5.4.0 (Thermo Fisher Scientific, USA). Unit: mm
Horizontal coronal implant position deviation
Time frame: 3 months after implant placement
Measurement: comparison of planned and actual implant position in a virtual model. Tool: Linear measurement with Amira 5.4.0 (Thermo Fisher Scientific, USA). Unit: mm
Horizontal apical implant position deviation
Time frame: 3 months after implant placement
Measurement: comparison of planned and actual implant position in a virtual model. Tool: Linear measurement with Amira 5.4.0 (Thermo Fisher Scientific, USA). Unit: mm
Angular implant position deviation
Time frame: 3 months after implant placement
Measurement: comparison of planned and actual implant position in a virtual model. Tool: Linear measurement with Amira 5.4.0 (Thermo Fisher Scientific, USA). Unit: mm
3 secondary outcomes
Implant insertion torque
Time frame: During implant insertion
Implant insertion torque
Time frame: During implant insertion
Duration of implant insertion
Time frame: During implant insertion
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 22 Apr 2021.
- Derived from this study: PubMed 34401946Orban K, Varga E Jr, Windisch P, Braunitzer G, Molnar B. Accuracy of half-guided implant placement with machine-driven or manual insertion: a prospective, randomized clinical study. Clin Oral Investig. 2022 Jan;26(1):1035-1043. doi: 10.1007/s00784-021-04087-0. Epub 2021 Aug 16.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Half-guided implant placement in people with Partial-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 4 inclusion and 3 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 22 Apr 2021. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Global coronal implant position deviation (time frame: 3 months after implant placement). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04854239, which also lists 1 linked publication.
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 22 Apr 2021.