Edentulous JawsNCT01866696
Computer Assisted Implant Surgery and Immediate Loading
A study testing oral implants in people with Edentulous Jaws, run by Università degli Studi di Sassari at 1 site in Italy.
Trial summary
Purpose: The aim of this study was to analyze the clinical and radiographic outcomes of 23 edentulous jaws treated with 3D software planning, guided surgery, immediate loading and restored with Cad-Cam Zirconia and titanium full arch frameworks. Read more about this study
- Who is it for?
- Ages 39 to 78 years
- Conditions the study is for
- Edentulous Jaws
- What is being tested?
- oral implants
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2006to Jun 2012
- 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 39 to 78 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -edentulous patients or patients with hopeless teeth in need to be restored with full arches prosthesis
Who cannot join
- presence of systemic diseases (i.e. haematologic disease, uncontrolled diabetes, serious coagulopathies and diseases of the immune system)
- irradiation to the head or neck region within 12 months before surgery
- presence severe bruxism or clenching habits
- pregnancy
- poor oral hygiene
- poor motivation to return for scheduled follow-up visit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Computer Assisted Implant Surgery and Immediate Loading With Full-arch Screw Retained Prosthesis
Purpose: The aim of this study was to analyze the clinical and radiographic outcomes of 23 edentulous jaws treated with 3D software planning, guided surgery, immediate loading and restored with Cad-Cam Zirconia and titanium full arch frameworks.
Material \& methods: This study was designed as a prospective clinical trial. Twenty patients have been consecutively rehabilitated with an immediately loaded implant supported fixed full prosthesis. A total of 120 fixtures supporting 23 bridges (8 mandible, 15 maxilla) were placed , 22 of which in fresh post extraction sockets. All the implants were inserted with an insertion torque of 35/45 Ncm. 117 out of 120 implants were immediately loaded the other 3 were delayed loaded.
Outcome measures were implants survival, radiographic marginal bone-levels and bone remodeling, soft tissue parameters and complications.
- Conditions
- Edentulous Jaws
- Being tested
- oral implants
- Keywords
- Computer assisted implant surgery,, Immediate loading,, CAD/CAM
- Medical subject headings
- Jaw, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral implantsDevice
Also called Oral implants Nobel Replace Tapered Groovy; Nobel Biocare AB, Goteborg, Sweden
For all cases, the following surgical and prosthetic protocol was followed.:
- Clinical examination
- Radiological examination
- Guided oral implants insertion
- Immediate Prosthetic loading
- Follow-up
| Study group | Role | What they receive |
|---|---|---|
| guided implant insertion and immediate loading | Experimental | This work was designed as a prospective case series clinical study. Twenty patients have been consecutively rehabilitated with an immediately loaded oral implant supported fixed full prosthesis. A total of 120 oral implants (Nobel Replace Tapered Groovy; Nobel Biocare AB, Goteborg, Sweden) supporting 23 bridges (8 mandible, 15 maxilla) were placed , 22 of which in fresh post extraction sockets. 117 out of 120 oral implants were immediately loaded. Receives: Device: oral implants |
What is being measured
The primary outcome is the main question the study is designed to answer.
implants survival
Measured: 0-30 months
Secondary outcomes (1)
peri-implant bone
marginal bone remodeling and marginal bone level
Measured: 12-30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2013 (estimated)
- Study startApr 2006
- Primary completionJun 2011
- Study completionJun 2012
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 Edentulous JawsStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università degli Studi di Sassari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guglielmo Campus, Università degli Studi di Sassari
- Investigators
- Silvio M Meloni, DDS, Study director, Università degli Studi di Sassari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01866696
- Sponsor's protocol ID
- ID051313
- Status last verified
- May 2013
- First submitted
- 13 May 2013
- Last updated
- 31 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Meloni SM, De Riu G, Pisano M, Lolli FM, Deledda A, Campus G, Tullio A. Implant Restoration of Edentulous Jaws with 3D Software Planning, Guided Surgery, Immediate Loading, and CAD-CAM Full Arch Frameworks. Int J Dent. 2013;2013:683423. doi: 10.1155/2013/683423. Epub 2013 Jul 29.
PubMed 23983690
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer Assisted Implant Surgery and Immediate Loading With Full-arch Screw Retained Prosthesis
- ClinicalTrials.gov ID
- NCT01866696
- Acronym / sponsor ID
- ID051313
- Conditions
- Edentulous Jaws
- Keywords
- Computer assisted implant surgery,, Immediate loading,, CAD/CAM
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Università degli Studi di SassariUniversity, hospital or other
- Study start
- Apr 2006
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 31 May 2013 (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.
Purpose: The aim of this study was to analyze the clinical and radiographic outcomes of 23 edentulous jaws treated with 3D software planning, guided surgery, immediate loading and restored with Cad-Cam Zirconia and titanium full arch frameworks.
Material \& methods: This study was designed as a prospective clinical trial. Twenty patients have been consecutively rehabilitated with an immediately loaded implant supported fixed full prosthesis. A total of 120 fixtures supporting 23 bridges (8 mandible, 15 maxilla) were placed , 22 of which in fresh post extraction sockets. All the implants were inserted with an insertion torque of 35/45 Ncm. 117 out of 120 implants were immediately loaded the other 3 were delayed loaded.
Outcome measures were implants survival, radiographic marginal bone-levels and bone remodeling, soft tissue parameters and complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| guided implant insertion and immediate loading | Experimental | Device: oral implantsThis work was designed as a prospective case series clinical study. Twenty patients have been consecutively rehabilitated with an immediately loaded oral implant supported fixed full prosthesis. A total of 120 oral implants (Nobel Replace Tapered Groovy; Nobel Biocare AB, Goteborg, Sweden) supporting 23 bridges (8 mandible, 15 maxilla) were placed , 22 of which in fresh post extraction sockets. 117 out of 120 oral implants were immediately loaded. |
Who may qualify
- Ages
- 39 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -edentulous patients or patients with hopeless teeth in need to be restored with full arches prosthesis
Key exclusion criteria (6 listed)
- presence of systemic diseases (i.e. haematologic disease, uncontrolled diabetes, serious coagulopathies and diseases of the immune system)
- irradiation to the head or neck region within 12 months before surgery
- presence severe bruxism or clenching habits
- pregnancy
- poor oral hygiene
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 |
|---|---|---|
| oral implantsAlso: Oral implants Nobel Replace Tapered Groovy; Nobel Biocare AB, Goteborg, SwedenFor all cases, the following surgical and prosthetic protocol was followed.: * Clinical examination * Radiological examination * Guided oral implants insertion * Immediate Prosthetic loading * Follow-up | Device | guided implant insertion and immediate loading |
Primary outcome
implants survival
Time frame: 0-30 months
1 secondary outcome
peri-implant bone
Time frame: 12-30 months
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 31 May 2013.
- Derived from this study: PubMed 23983690Meloni SM, De Riu G, Pisano M, Lolli FM, Deledda A, Campus G, Tullio A. Implant Restoration of Edentulous Jaws with 3D Software Planning, Guided Surgery, Immediate Loading, and CAD-CAM Full Arch Frameworks. Int J Dent. 2013;2013:683423. doi: 10.1155/2013/683423. Epub 2013 Jul 29.
Related trials for Edentulous Jaws
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Dynamic vs. Static Jaw Relations in Implant-Supported Prostheses: Chewing Efficiency
Chewing Efficiency in Completely Edentulous Patients Rehabilitated With Implant-Supported Full-Arch Prostheses
Active, not recruiting
Multicenter Study to Evaluate the Clinical Outcome of PrimeTaper EV Implant in Single Tooth Restorations
Jaw, Edentulous, Partially
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Clinical and Radiographic Evaluation of UV-Treated Dental Implants With or Without Melatonin in the Upper Posterior Jaw
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A Clinical Study on Acuris™ - Conometric Concept for Single Tooth Restoration
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Recruiting
Clinical Outcomes of 3D Printed and Milled Complete Dentures
Edentulous Mouth, Edentulous Jaw
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.
Silvio M Meloni, DDS study director
Università degli Studi di Sassari
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oral implants in people with Edentulous Jaws, run by Università degli Studi di Sassari at 1 site in Italy.
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 6 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 31 May 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 Italy. 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?
implants survival (time frame: 0-30 months). 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 NCT01866696, 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 31 May 2013.