Bone-to-implant ContactNCT01905306
Randomized Controlled Trial of Full-Arch Rehabilitation
A study testing computer guided implant planning and free hand implants placement in people with Bone-to-implant Contact and Success Rate, run by University of Siena at 1 site in Italy.
Trial summary
This clinical study has the objective to compare the radiographic evaluations after 3 years of follow-up of immediate loaded implant-prosthetic rehabilitation, carried out randomly using the methodology for computer guided implant planning with software polyvalent or free hand implants placement. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Bone-to-implant Contact, Success Rate, Survival Rate
- What is being tested?
- computer guided implant planning and free hand implants placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2013to Jul 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Edentulous patients with an adequate area: at least two teeth in the posterior area
- Age over 18 years
- Adequate width of the bone crest without the need for bone regeneration
- Consensus to participate in a oral hygiene maintenance program
- Consensus to participate in a long-term study
- Availability to provide their free and informed consensus.
Who cannot join
- Systemic diseases that preclude participation in the study
- History of radiation therapy
- Bone lesions
- Cigarette smoking (more than 10 cigarettes per day)
- Inadequate oral hygiene
- Untreated periodontitis affecting residual teeth
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Dental Materials and Fixed Prosthodontics of Siena, Tuscan School of Dental Medicine, University of Florence and Siena
Siena, Siena, 53100
About this study
Official title: Clinical Evaluation of Immediate Loading Full Arch Rehabilitation Made With Methodology for Computer Guided Implant Planning With Software Polyvalent vs Free Hand Implants Placement
This clinical study has the objective to compare the radiographic evaluations after 3 years of follow-up of immediate loaded implant-prosthetic rehabilitation, carried out randomly using the methodology for computer guided implant planning with software polyvalent or free hand implants placement.
- Conditions
- Bone-to-implant Contact, Success Rate, Survival Rate
- Being tested
- computer guided implant planning, free hand implants placement
- Keywords
- dental implants, immediate loading, full-arch, computer guided implant surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
computer guided implant planningProcedure or surgery
free hand implants placementProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| computer guided implant planning | Experimental | radiographic and clinical evaluation of full-arch dental implant rehabilitation Receives: Procedure: computer guided implant planning |
| free hand implants placement | Experimental | radiographic and clinical evaluation of full-arch dental implant rehabilitation Receives: Procedure: free hand implants placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
bone-to-implant contact
2D radiographic assessment of the implant surface in contact with bone expressed in percentage
Measured: 3 years
Secondary outcomes (1)
implant survival rate
- the absence of clinically detectable implant mobility
- a lack of persistent or irreversible signs and symptoms such as pain or any subjective sensation
- the absence of recurrent peri-implant infection
- the absence of concrete evidence of continuous periimplant radiolucency
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2013 (estimated)
- Study startJan 2013
- Primary completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Bone-to-implant ContactStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Siena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Marco Ferrari, University of Siena
- Investigators
- Marco Ferrari, Prof, Principal investigator, University of Florence and Siena, Siena, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01905306
- Sponsor's protocol ID
- RCTGIS1
- Other IDs
- RCTGIS1s
- Status last verified
- Jul 2013
- First submitted
- 16 Jul 2013
- Last updated
- 23 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Drago C, del Castillo R, Peterson T. Immediate occlusal loading in edentulous jaws, CT-guided surgery and fixed provisional prosthesis: a maxillary arch clinical report. J Prosthodont. 2011 Apr;20(3):209-17. doi: 10.1111/j.1532-849X.2010.00661.x. Epub 2010 Nov 11.
PubMed 21070431Case study: computer-guided implant successful in high-risk patient. J Calif Dent Assoc. 2012 Oct;40(10):784. No abstract available.
PubMed 23316558Margonar R, Queiroz TP, Luvizuto ER, Santos PL, Wady AF, Paleari AG. Anterior tooth rehabilitation with frozen homogenous bone graft and immediately loaded titanium implant using computer-guided surgery. J Craniofac Surg. 2012 Sep;23(5):e470-2. doi: 10.1097/SCS.0b013e3182587516.
PubMed 22976712Nickenig HJ, Eitner S, Rothamel D, Wichmann M, Zoller JE. Possibilities and limitations of implant placement by virtual planning data and surgical guide templates. Int J Comput Dent. 2012;15(1):9-21. English, German.
PubMed 22930944Shibly O, Kutkut A, Albandar JM. One-year re-entry results of guided bone regeneration around immediately placed implants with immediate or conventional loading: a case series. J Int Acad Periodontol. 2012 Jul;14(3):62-8.
PubMed 22908535Schnitman PA, Lee SJ, Campard GJ, Dona M. Guided flapless surgery with immediate loading for the high narrow ridge without grafting. J Oral Implantol. 2012 Jun;38(3):279-88. doi: 10.1563/AAID-JOI-D-11-00215.
PubMed 22783940
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Immediate Loading Full Arch Rehabilitation Made With Methodology for Computer Guided Implant Planning With Software Polyvalent vs Free Hand Implants Placement
- ClinicalTrials.gov ID
- NCT01905306
- Acronym / sponsor ID
- RCTGIS1
- Conditions
- Bone-to-implant Contact, Success Rate, Survival Rate
- Keywords
- dental implants, immediate loading, full-arch, computer guided implant surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of SienaUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jul 2016 (estimated)
- First posted
- 23 Jul 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.
This clinical study has the objective to compare the radiographic evaluations after 3 years of follow-up of immediate loaded implant-prosthetic rehabilitation, carried out randomly using the methodology for computer guided implant planning with software polyvalent or free hand implants placement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| computer guided implant planning | Experimental | Procedure: computer guided implant planningradiographic and clinical evaluation of full-arch dental implant rehabilitation |
| free hand implants placement | Experimental | Procedure: free hand implants placementradiographic and clinical evaluation of full-arch dental implant rehabilitation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Edentulous patients with an adequate area: at least two teeth in the posterior area
- Age over 18 years
- Adequate width of the bone crest without the need for bone regeneration
- Consensus to participate in a oral hygiene maintenance program
- Consensus to participate in a long-term study
Key exclusion criteria (6 listed)
- Systemic diseases that preclude participation in the study
- History of radiation therapy
- Bone lesions
- Cigarette smoking (more than 10 cigarettes per day)
- Inadequate 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 |
|---|---|---|
| computer guided implant planning | Procedure or surgery | computer guided implant planning |
| free hand implants placement | Procedure or surgery | free hand implants placement |
Primary outcome
bone-to-implant contact
Time frame: 3 years
2D radiographic assessment of the implant surface in contact with bone expressed in percentage
1 secondary outcome
implant survival rate
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2013.
- Background: PubMed 21070431Drago C, del Castillo R, Peterson T. Immediate occlusal loading in edentulous jaws, CT-guided surgery and fixed provisional prosthesis: a maxillary arch clinical report. J Prosthodont. 2011 Apr;20(3):209-17. doi: 10.1111/j.1532-849X.2010.00661.x. Epub 2010 Nov 11.
- Background: PubMed 23316558Case study: computer-guided implant successful in high-risk patient. J Calif Dent Assoc. 2012 Oct;40(10):784. No abstract available.
- Background: PubMed 22976712Margonar R, Queiroz TP, Luvizuto ER, Santos PL, Wady AF, Paleari AG. Anterior tooth rehabilitation with frozen homogenous bone graft and immediately loaded titanium implant using computer-guided surgery. J Craniofac Surg. 2012 Sep;23(5):e470-2. doi: 10.1097/SCS.0b013e3182587516.
- Background: PubMed 22930944Nickenig HJ, Eitner S, Rothamel D, Wichmann M, Zoller JE. Possibilities and limitations of implant placement by virtual planning data and surgical guide templates. Int J Comput Dent. 2012;15(1):9-21. English, German.
- Background: PubMed 22908535Shibly O, Kutkut A, Albandar JM. One-year re-entry results of guided bone regeneration around immediately placed implants with immediate or conventional loading: a case series. J Int Acad Periodontol. 2012 Jul;14(3):62-8.
- Background: PubMed 22783940Schnitman PA, Lee SJ, Campard GJ, Dona M. Guided flapless surgery with immediate loading for the high narrow ridge without grafting. J Oral Implantol. 2012 Jun;38(3):279-88. doi: 10.1563/AAID-JOI-D-11-00215.
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.
Marco Ferrari, Prof principal investigator
University of Florence and Siena, Siena, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing computer guided implant planning and free hand implants placement in people with Bone-to-implant Contact and Success Rate, run by University of Siena 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 6 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: status not confirmed, as of the sponsor's last update on 23 Jul 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?
Results are not available in the source record.
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?
bone-to-implant contact (time frame: 3 years). 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 NCT01905306, which also lists 6 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 23 Jul 2013.