StereolithographystereolithoNCT01027442
The Use of Bone-, Tooth- and Mucosa- Supported Stereolithographic Guides for Dental Implant Placement
A study testing Mucosa-supported single-type guides, Bone-supported guides and Dental Implants in people with Stereolithography and Dental Implants, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
Introduction: The use stereolithographic (SLA) guides may provide significant benefits in simultaneous placement of multiple implants, especially in large edentulous areas lacking anatomic landmarks for surgical reference. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stereolithography, Dental Implants, Prosthesis
- What is being tested?
- Mucosa-supported single-type guides, Bone-supported guides and Dental Implants
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jul 2008to Dec 2009
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy patient with at leat one edentuşous jaw
Who cannot join
- Patients with at least one edentulous jaw with healthy systemic and oral status without severe alveolar bone athrophy, major alveolar hard and/or soft tissue deficiency, mouth opening restriction, heavy smoking (> 10 /per day) and parafunctional habits were included in the study.
- All patients were initially evaluated for the suitability of an implant supported fixed prosthesis and any patients unsuitable for such prosthetic superstructure (i.e. severe hard and soft tissue athrophy, insufficient hygiene practice etc.) were excluded.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Department of Oral Implantology, Faculty of Dentistry, ıstnabul University
Istanbul, Capa, 34390
About this study
Official title: Conventional Versus Computer Aided Implantology
Introduction:
The use stereolithographic (SLA) guides may provide significant benefits in simultaneous placement of multiple implants, especially in large edentulous areas lacking anatomic landmarks for surgical reference. Planning of the implant positions prior to surgery may shorten the duration of the surgery spent by exploring and determining the suitable implant location on the edentulous alveolar crest in the standard technique . Previous studies have demonstrated the use of many SLA guide in this manner, however; most were designed to be used as placed on the alveolar crest (bone-supported) following a flap exposure, and there was no depth-control of the osteotomy drills. Further advances in stereolithography allowed flapless surgeries to be performed via mucosa-supported guides (Rosenfeld, et al. 2006c, Tardieu, et al. 2007). The use of these guides eliminates not only the time required for incision and flap exposure but post-operative patient morbidity and discomfort may also be reduced, due to the non-invasive nature of the procedure. The aim of this study is to investigate the accuracy, surgical and post-operative complications and post-loading outcomes of implants placed by the conventional and aforementioned computer-aided methods.
- Conditions
- Stereolithography, Dental Implants, Prosthesis
- Being tested
- Mucosa-supported single-type guides, Bone-supported guides, Dental Implants
- Keywords
- Stereolithography, Dental implants,, Prosthetics, positioning-errors, logistic regression analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mucosa-supported single-type guidesDevice
Also called Simplant, SAFEsystem, Materialise Dental, Leuven , Belgium
Compute generated Mucosa-supported single-type guides
Bone-supported guidesDevice
Also called Aytasarim, Classic. Odtu-Kosgep, Ankara, Turkey
Computer generated, Multiple type Bone-supported guides
Dental ImplantsDevice
Also called Thommen Medical SPI, Waldenburg, Switzerland, Frident Xixe, dentsply Friadent-Turkey
Dental implants placed via conventional free-hand method
| Study group | Role | What they receive |
|---|---|---|
| Conventional implant placement method | Placebo comparator | The patients in ths group will be treated by conventional, "free-hand" implant placement Receives: Device: Dental Implants |
| Computer-guidedimplant placement | Active comparator | In this group, the patients will be treated by implants placed via computer generated SLA guides Receives: Device: Mucosa-supported single-type guides; Device: Bone-supported guides |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2009 (estimated)
- Study startJul 2008
- Primary completionJan 2009
- Study completionDec 2009
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 StereolithographyStudies of the same condition, open and under way.
- More trials run by Istanbul 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Collaborators
- Risus medikal, Thommen medical (Switzerland) Turkish partner, Dentsply Implants Manufacturing GmbH
- Investigators
- Tayfun Ozdemir, Prof.Dr., Study chair, Section head: Department of Implantology, Faculty of Dentistry, Istabul UniversityVolkan Arısan, Dr.Med.Dent, Principal investigator, Department of Oral Implantology, Istanbul UniversityCuneyt Z Karabuda, Prof.Dr., Study director, Department of Oral Implantology, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01027442
- Sponsor's protocol ID
- Stereolithographic guides
- Other IDs
- Implant with SLA
- Acronym
- stereolitho
- Status last verified
- Jun 2007
- First submitted
- 7 Dec 2009
- Last updated
- 27 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Arisan V, Karabuda ZC, Ozdemir T. Accuracy of two stereolithographic guide systems for computer-aided implant placement: a computed tomography-based clinical comparative study. J Periodontol. 2010 Jan;81(1):43-51. doi: 10.1902/jop.2009.090348.
PubMed 20059416Arisan V, Karabuda CZ, Ozdemir T. Implant surgery using bone- and mucosa-supported stereolithographic guides in totally edentulous jaws: surgical and post-operative outcomes of computer-aided vs. standard techniques. Clin Oral Implants Res. 2010 Sep;21(9):980-8. doi: 10.1111/j.1600-0501.2010.01957.x. Epub 2010 May 24.
PubMed 20497439Arisan V, Karabuda CZ, Mumcu E, Ozdemir T. Implant positioning errors in freehand and computer-aided placement methods: a single-blind clinical comparative study. Int J Oral Maxillofac Implants. 2013 Jan-Feb;28(1):190-204. doi: 10.11607/jomi.2691.
PubMed 23377066Arisan V, Bolukbasi N, Oksuz L. Computer-assisted flapless implant placement reduces the incidence of surgery-related bacteremia. Clin Oral Investig. 2013 Dec;17(9):1985-93. doi: 10.1007/s00784-012-0886-y. Epub 2012 Dec 6.
PubMed 23224042
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conventional Versus Computer Aided Implantology
- ClinicalTrials.gov ID
- NCT01027442
- Acronym / sponsor ID
- stereolitho / Stereolithographic guides
- Conditions
- Stereolithography, Dental Implants, Prosthesis
- Keywords
- Stereolithography, Dental implants,, Prosthetics, positioning-errors, logistic regression analysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Collaborators
- Risus medikal, Thommen medical (Switzerland) Turkish partner, Dentsply Implants Manufacturing GmbH
- Study start
- Jul 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 8 Dec 2009 (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.
Introduction:
The use stereolithographic (SLA) guides may provide significant benefits in simultaneous placement of multiple implants, especially in large edentulous areas lacking anatomic landmarks for surgical reference. Planning of the implant positions prior to surgery may shorten the duration of the surgery spent by exploring and determining the suitable implant location on the edentulous alveolar crest in the standard technique . Previous studies have demonstrated the use of many SLA guide in this manner, however; most were designed to be used as placed on the alveolar crest (bone-supported) following a flap exposure, and there was no depth-control of the osteotomy drills. Further advances in stereolithography allowed flapless surgeries to be performed via mucosa-supported guides (Rosenfeld, et al. 2006c, Tardieu, et al. 2007). The use of these guides eliminates not only the time required for incision and flap exposure but post-operative patient morbidity and discomfort may also be reduced, due to the non-invasive nature of the procedure. The aim of this study is to investigate the accuracy, surgical and post-operative complications and post-loading outcomes of implants placed by the conventional and aforementioned computer-aided methods.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional implant placement method | Placebo comparator | Device: Dental ImplantsThe patients in ths group will be treated by conventional, "free-hand" implant placement |
| Computer-guidedimplant placement | Active comparator | Device: Mucosa-supported single-type guides, Device: Bone-supported guidesIn this group, the patients will be treated by implants placed via computer generated SLA guides |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy patient with at leat one edentuşous jaw
Key exclusion criteria (2 listed)
- Patients with at least one edentulous jaw with healthy systemic and oral status without severe alveolar bone athrophy, major alveolar hard and/or soft tissue deficiency, mouth opening restriction, heavy smoking (> 10 /per day) and parafunctional habits were included in the study.
- All patients were initially evaluated for the suitability of an implant supported fixed prosthesis and any patients unsuitable for such prosthetic superstructure (i.e. severe hard and soft tissue athrophy, insufficient hygiene practice etc.) were excluded.
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 |
|---|---|---|
| Mucosa-supported single-type guidesAlso: Simplant, SAFEsystem, Materialise Dental, Leuven , BelgiumCompute generated Mucosa-supported single-type guides | Device | Computer-guidedimplant placement |
| Bone-supported guidesAlso: Aytasarim, Classic. Odtu-Kosgep, Ankara, TurkeyComputer generated, Multiple type Bone-supported guides | Device | Computer-guidedimplant placement |
| Dental ImplantsAlso: Thommen Medical SPI, Waldenburg, Switzerland, Frident Xixe, dentsply Friadent-TurkeyDental implants placed via conventional free-hand method | Device | Conventional implant placement method |
Primary outcome
Not reported in the source record.
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 Nov 2013.
- Results publication: PubMed 20059416Arisan V, Karabuda ZC, Ozdemir T. Accuracy of two stereolithographic guide systems for computer-aided implant placement: a computed tomography-based clinical comparative study. J Periodontol. 2010 Jan;81(1):43-51. doi: 10.1902/jop.2009.090348.
- Results publication: PubMed 20497439Arisan V, Karabuda CZ, Ozdemir T. Implant surgery using bone- and mucosa-supported stereolithographic guides in totally edentulous jaws: surgical and post-operative outcomes of computer-aided vs. standard techniques. Clin Oral Implants Res. 2010 Sep;21(9):980-8. doi: 10.1111/j.1600-0501.2010.01957.x. Epub 2010 May 24.
- Results publication: PubMed 23377066Arisan V, Karabuda CZ, Mumcu E, Ozdemir T. Implant positioning errors in freehand and computer-aided placement methods: a single-blind clinical comparative study. Int J Oral Maxillofac Implants. 2013 Jan-Feb;28(1):190-204. doi: 10.11607/jomi.2691.
- Results publication: PubMed 23224042Arisan V, Bolukbasi N, Oksuz L. Computer-assisted flapless implant placement reduces the incidence of surgery-related bacteremia. Clin Oral Investig. 2013 Dec;17(9):1985-93. doi: 10.1007/s00784-012-0886-y. Epub 2012 Dec 6.
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.
Tayfun Ozdemir, Prof.Dr. study chair
Section head: Department of Implantology, Faculty of Dentistry, Istabul University
Volkan Arısan, Dr.Med.Dent principal investigator
Department of Oral Implantology, Istanbul University
Cuneyt Z Karabuda, Prof.Dr. study director
Department of Oral Implantology, Istanbul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mucosa-supported single-type guides, Bone-supported guides and Dental Implants in people with Stereolithography and Dental Implants, run by Istanbul University at 1 site in Turkey (Türkiye).
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 1 inclusion and 2 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 Nov 2013. 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 Turkey (Türkiye). 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. Some participants in this study may receive a placebo. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01027442, 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 Nov 2013.