Jaw, EdentulousSTIMPLANTSRGNCT02418117
Accuracy of Computer Guided Implant Surgery
A study testing Stereolitographic template in people with Jaw, Edentulous, run by Concordia Dent Srl at 1 site in Romania.
Trial summary
The investigators' aim is to evaluate the accuracy of the stereolitographic template comparing the final implant insertion to the planned implant position at coronal and apical level. Clinical relevance: To identify factors influencing the surgical template imprecision. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Jaw, Edentulous
- What is being tested?
- Stereolitographic template
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteRomania
- Study dates
- Jul 2015to Jan 2016
- Phase
- Interventional
- 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 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- fully or partially edentulous patients,
- good general healty with no contraindications for implant surgery,
- acceptance of dental implant treatment,
- acceptance of at least 2 CBCT (one at treatment planning and one after surgery)
Who cannot join
- limited bone volume with stadial bone graft requirement,
- limited mouth opening (imposible to use the surgical stent),
- parkinson desease (imposible to perform an accurate CBCT)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Accuracy of Computer Guided Implant Surgery With the Use of R2Gate Stereolitographic Template
The investigators' aim is to evaluate the accuracy of the stereolitographic template comparing the final implant insertion to the planned implant position at coronal and apical level.
Clinical relevance:
- To identify factors influencing the surgical template imprecision.
- To overcome risk factors for surgical template imprecision.
- To suggest improvements for highly accuracy of the surgical template especially for immediate loading and avoiding the injury of anatomical structures.
Read the detailed description
Initial examination, panoramic radiograph to be performed and impression for stone models to be taken to all enrolled patients. For diagnosis accuracy, impression of the surgical site and the opposite arch is mandatory.
For fully edentulous and extensive edentulous subjects - Class III and IV according to the American College of Prosthodontists - ACP - a visible light cure record bases with occlusal rims will be manufactured for bite registration.
CBCT will be taken with a R2 tray filled with impression material or with record basis in centric relation (CR).
CBCT will be performed using same CT machine with a specific setup and alignment to allow accuracy and reproducibility.
A series of axially sliced image data will be obtained and exported to a personal computer in DICOM (Digital Imaging and Communications in Medicine) format.
Models, occlusal rims and R2 trays will be scanned and imported as STL (Stereo Lithography) files.
On the scan models, a virtual wax-up will be designed with the use of 3Shape CAD (Computer Aided Design) software and saved as STL file.
Matching CT and models scan data DICOM files obtained from CBCT and STL files will be imported in a treatment plan software R2GATE version 1.0.3 (Megagen Implant, Korea) and implant insertion will be planned according to the final restoration and bone anatomy.
AnyRidge Megagen implants will be used with length and diameters required by the clinical cases.
A stereolitographic template manufactured by DDX Europa, after final decision of treatment plan, will be used for dental implants insertion using a minimally invasive flapless approach.
To assess accuracy of the surgical template, a new CBCT with specific set-up and alignment after implant insertion will be performed.
Matching post-op CT with the planed position of the implants will be performed using the R2GATE software and measurements between the location of implants on CT at the time of planning and after implantation will be made at the coronal and apical levels to determine the distance between the implant and the planned position buccal, oral, mesial and distal by two independent researchers. Angulation between the implant position and the planned position at coronal and apical level will be also measured.
Statistical analysis will be performed. Teeth supported, mucosal supported and teeth-mucosal supported surgical stereolitographic template will be analyzed separately.
- Conditions
- Jaw, Edentulous
- Being tested
- Stereolitographic template
- Keywords
- Stereolitographic guide, flapless surgery, dental implants
- Medical subject headings
- Jaw, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereolitographic templateOther
Flapless (atraumatic) dental implants insertion with the aid of a stereolitographic template.
| Study group | Role | What they receive |
|---|---|---|
| Stereolitographic template's accuracy | Experimental | Evaluating the accuracy of stereolitographic template comparing the final implant insertion to the planned implant position at coronal and apical level Receives: Other: Stereolitographic template |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurements of accuracy after implants placement at coronal and apical level
Measurements between the location of implants on CT at the time of planning and after implantation will be made at the coronal and apical levels to determine the distance between the implant and the planned position buccal, oral, mesial and distal.
Measured: average 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2015 (estimated)
- Study startJul 2015
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Jaw, EdentulousStudies of the same condition, open and under way.
- 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 N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Concordia Dent Srl
- Sponsor type
- University, hospital or other
- Collaborators
- Carol Davila University of Medicine and Pharmacy, MEGAGEN DENTAL IMPLANT ROMANIA
- Responsible party
- Principal investigator, Corina Marilena Cristache, Concordia Dent Srl
- Investigators
- CORINA MARILENA I CRISTACHE, DMD, PhD, Principal investigator, Carol Davila University of Medicine and Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02418117
- Sponsor's protocol ID
- 613/15
- Acronym
- STIMPLANTSRG
- Status last verified
- Jan 2016
- First submitted
- 9 Apr 2015
- Last updated
- 27 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Vasak C, Kohal RJ, Lettner S, Rohner D, Zechner W. Clinical and radiological evaluation of a template-guided (NobelGuide) treatment concept. Clin Oral Implants Res. 2014 Jan;25(1):116-23. doi: 10.1111/clr.12038. Epub 2012 Sep 18.
PubMed 22984962Yatzkair G, Cheng A, Brodie S, Raviv E, Boyan BD, Schwartz Z. Accuracy of computer-guided implantation in a human cadaver model. Clin Oral Implants Res. 2015 Oct;26(10):1143-9. doi: 10.1111/clr.12482. Epub 2014 Sep 15.
PubMed 25220954Beretta M, Poli PP, Maiorana C. Accuracy of computer-aided template-guided oral implant placement: a prospective clinical study. J Periodontal Implant Sci. 2014 Aug;44(4):184-93. doi: 10.5051/jpis.2014.44.4.184. Epub 2014 Aug 28.
PubMed 25177520Van Assche N, Vercruyssen M, Coucke W, Teughels W, Jacobs R, Quirynen M. Accuracy of computer-aided implant placement. Clin Oral Implants Res. 2012 Oct;23 Suppl 6:112-23. doi: 10.1111/j.1600-0501.2012.02552.x.
PubMed 23062136
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Computer Guided Implant Surgery With the Use of R2Gate Stereolitographic Template
- ClinicalTrials.gov ID
- NCT02418117
- Acronym / sponsor ID
- STIMPLANTSRG / 613/15
- Conditions
- Jaw, Edentulous
- Keywords
- Stereolitographic guide, flapless surgery, dental implants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Concordia Dent SrlUniversity, hospital or other
- Collaborators
- Carol Davila University of Medicine and Pharmacy, MEGAGEN DENTAL IMPLANT ROMANIA
- Study start
- Jul 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 16 Apr 2015 (estimated)
- 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 investigators' aim is to evaluate the accuracy of the stereolitographic template comparing the final implant insertion to the planned implant position at coronal and apical level.
Clinical relevance:
- To identify factors influencing the surgical template imprecision.
- To overcome risk factors for surgical template imprecision.
- To suggest improvements for highly accuracy of the surgical template especially for immediate loading and avoiding the injury of anatomical structures.
Detailed description
Initial examination, panoramic radiograph to be performed and impression for stone models to be taken to all enrolled patients. For diagnosis accuracy, impression of the surgical site and the opposite arch is mandatory.
For fully edentulous and extensive edentulous subjects - Class III and IV according to the American College of Prosthodontists - ACP - a visible light cure record bases with occlusal rims will be manufactured for bite registration.
CBCT will be taken with a R2 tray filled with impression material or with record basis in centric relation (CR).
CBCT will be performed using same CT machine with a specific setup and alignment to allow accuracy and reproducibility.
A series of axially sliced image data will be obtained and exported to a personal computer in DICOM (Digital Imaging and Communications in Medicine) format.
Models, occlusal rims and R2 trays will be scanned and imported as STL (Stereo Lithography) files.
On the scan models, a virtual wax-up will be designed with the use of 3Shape CAD (Computer Aided Design) software and saved as STL file.
Matching CT and models scan data DICOM files obtained from CBCT and STL files will be imported in a treatment plan software R2GATE version 1.0.3 (Megagen Implant, Korea) and implant insertion will be planned according to the final restoration and bone anatomy.
AnyRidge Megagen implants will be used with length and diameters required by the clinical cases.
A stereolitographic template manufactured by DDX Europa, after final decision of treatment plan, will be used for dental implants insertion using a minimally invasive flapless approach.
To assess accuracy of the surgical template, a new CBCT with specific set-up and alignment after implant insertion will be performed.
Matching post-op CT with the planed position of the implants will be performed using the R2GATE software and measurements between the location of implants on CT at the time of planning and after implantation will be made at the coronal and apical levels to determine the distance between the implant and the planned position buccal, oral, mesial and distal by two independent researchers. Angulation between the implant position and the planned position at coronal and apical level will be also measured.
Statistical analysis will be performed. Teeth supported, mucosal supported and teeth-mucosal supported surgical stereolitographic template will be analyzed separately.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stereolitographic template's accuracy | Experimental | Other: Stereolitographic templateEvaluating the accuracy of stereolitographic template comparing the final implant insertion to the planned implant position at coronal and apical level |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- fully or partially edentulous patients,
- good general healty with no contraindications for implant surgery,
- acceptance of dental implant treatment,
- acceptance of at least 2 CBCT (one at treatment planning and one after surgery)
Key exclusion criteria (3 listed)
- limited bone volume with stadial bone graft requirement,
- limited mouth opening (imposible to use the surgical stent),
- parkinson desease (imposible to perform an accurate CBCT)
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 |
|---|---|---|
| Stereolitographic templateFlapless (atraumatic) dental implants insertion with the aid of a stereolitographic template. | Other | Stereolitographic template's accuracy |
Primary outcome
Measurements of accuracy after implants placement at coronal and apical level
Time frame: average 10 days
Measurements between the location of implants on CT at the time of planning and after implantation will be made at the coronal and apical levels to determine the distance between the implant and the planned position buccal, oral, mesial and distal.
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 27 Jan 2016.
- Background: PubMed 22984962Vasak C, Kohal RJ, Lettner S, Rohner D, Zechner W. Clinical and radiological evaluation of a template-guided (NobelGuide) treatment concept. Clin Oral Implants Res. 2014 Jan;25(1):116-23. doi: 10.1111/clr.12038. Epub 2012 Sep 18.
- Background: PubMed 25220954Yatzkair G, Cheng A, Brodie S, Raviv E, Boyan BD, Schwartz Z. Accuracy of computer-guided implantation in a human cadaver model. Clin Oral Implants Res. 2015 Oct;26(10):1143-9. doi: 10.1111/clr.12482. Epub 2014 Sep 15.
- Background: PubMed 25177520Beretta M, Poli PP, Maiorana C. Accuracy of computer-aided template-guided oral implant placement: a prospective clinical study. J Periodontal Implant Sci. 2014 Aug;44(4):184-93. doi: 10.5051/jpis.2014.44.4.184. Epub 2014 Aug 28.
- Background: PubMed 23062136Van Assche N, Vercruyssen M, Coucke W, Teughels W, Jacobs R, Quirynen M. Accuracy of computer-aided implant placement. Clin Oral Implants Res. 2012 Oct;23 Suppl 6:112-23. doi: 10.1111/j.1600-0501.2012.02552.x.
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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.
CORINA MARILENA I CRISTACHE, DMD, PhD principal investigator
Carol Davila University of Medicine and Pharmacy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stereolitographic template in people with Jaw, Edentulous, run by Concordia Dent Srl at 1 site in Romania.
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 27 Jan 2016. 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 Romania. 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?
Measurements of accuracy after implants placement at coronal and apical level (time frame: average 10 days). 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 NCT02418117, which also lists 4 linked publications.
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 27 Jan 2016.