Bone Involvement in Diseases Classified ElsewhereNCT02117882
Minimally Invasive Lateral Approach for Sinus Augmentation: a Split-mouth Randomized Clinical Trial.
An observational study of Bone Involvement in Diseases Classified Elsewhere, run by University of Firenze and Siena, Napoli, Italy at 1 site in Italy.
Trial summary
It is assumed that the minimally invasive lateral approach and the traditional lateral sinus lift procedure will result in better outcomes in terms of height of augmented bone. It is also assumed that the minimally invasive lateral approach will reduce surgical complications and patient's discomfort in comparison with… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Bone Involvement in Diseases Classified Elsewhere
- How many people
- 15 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2013to Apr 2014
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 15 patients edentulous in maxillary posterior area have been treated with a bilateral sinus lift procedure.
Who may be able to join
- - patient edentulous in the maxillary posterior area on both left and right side( not completely edentulous).
- - residual bone height in the maxillary premolar and molar region less than 4mm.
Who cannot join
- - history of systemic diseases that would contraindicate surgical treatment
Trial locations and contacts
1 site in 1 country.
Italy1 site
Siena University, Department of Periodontology, Policlinico Le Scotte Siena.
Siena, Siena, 53100
About this study
It is assumed that the minimally invasive lateral approach and the traditional lateral sinus lift procedure will result in better outcomes in terms of height of augmented bone.
It is also assumed that the minimally invasive lateral approach will reduce surgical complications and patient's discomfort in comparison with a traditional lateral sinus lift procedure.
Read the detailed description
16 patients edentulous in maxillary posterior area will be treated with a bilateral sinus lift procedure.
Once a patient will be enrolled in the study impressions will be taken. After the wax-up, a radiographic stent will be prepared. Special attention will be given to position radio-opaque references in the positions where the implants will be inserted according to a prosthodontic guided insertion. Pre-surgical CT scan will be executed after placing the stent in its proper position in patient's mouth. After that, if no surgical contra-indications will be detected at CT evaluation, patients will be enrolled for surgical interventions.
- Keywords
- lateral approach, bone augmentation , sinus floor elevation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| minimally invasive approach test | minimally invasive lateral approach | |
| control lateral traditional approach | standard surgical approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
height of augmented bone
Measured: 6 months
Secondary outcomes (1)
post surgical patient's discomfort
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2014 (estimated)
- Study startJan 2013
- Primary completionMar 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Involvement in Diseases Classified ElsewhereStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Firenze and Siena, Napoli, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, nicola baldini, University of Firenze and Siena, Napoli, Italy
- Investigators
- nicola nb baldini, oral surgeon, Principal investigator, tuscan school of dental medicine of florence and siena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02117882
- Sponsor's protocol ID
- misfe
- Status last verified
- Apr 2014
- First submitted
- 16 Apr 2014
- Last updated
- 21 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimally Invasive Lateral Approach for Sinus Augmentation: a Split-mouth Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT02117882
- Acronym / sponsor ID
- misfe
- Keywords
- lateral approach, bone augmentation , sinus floor elevation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of Firenze and Siena, Napoli, ItalyUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 21 Apr 2014 (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.
It is assumed that the minimally invasive lateral approach and the traditional lateral sinus lift procedure will result in better outcomes in terms of height of augmented bone.
It is also assumed that the minimally invasive lateral approach will reduce surgical complications and patient's discomfort in comparison with a traditional lateral sinus lift procedure.
Detailed description
16 patients edentulous in maxillary posterior area will be treated with a bilateral sinus lift procedure.
Once a patient will be enrolled in the study impressions will be taken. After the wax-up, a radiographic stent will be prepared. Special attention will be given to position radio-opaque references in the positions where the implants will be inserted according to a prosthodontic guided insertion. Pre-surgical CT scan will be executed after placing the stent in its proper position in patient's mouth. After that, if no surgical contra-indications will be detected at CT evaluation, patients will be enrolled for surgical interventions.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| minimally invasive approach test | – | –minimally invasive lateral approach |
| control lateral traditional approach | – | –standard surgical approach |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 15 patients edentulous in maxillary posterior area have been treated with a bilateral sinus lift procedure.
Key inclusion criteria (2 listed)
- - patient edentulous in the maxillary posterior area on both left and right side( not completely edentulous).
- - residual bone height in the maxillary premolar and molar region less than 4mm.
Key exclusion criteria (1 listed)
- - history of systemic diseases that would contraindicate surgical treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
height of augmented bone
Time frame: 6 months
1 secondary outcome
post surgical patient's discomfort
Time frame: 2 weeks
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 21 Apr 2014.
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.
nicola nb baldini, oral surgeon principal investigator
tuscan school of dental medicine of florence and siena
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Involvement in Diseases Classified Elsewhere, run by University of Firenze and Siena, Napoli, Italy 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 2 inclusion and 1 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 21 Apr 2014. 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?
height of augmented bone (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Apr 2014.