Bone Involvement in Diseases Classified ElsewhereNCT03272100
Influence of Two Different Flap Designs for Sinus Floor Elevation
An observational study of Bone Involvement in Diseases Classified Elsewhere, run by University of Firenze and Siena, Napoli, Italy at 2 sites in Italy.
Trial summary
It is assumed that the reduction of the flap dimension could provide a reduction of surgical time, post surgical complications and patient's discomfort when compared with the traditional surgical approach. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bone Involvement in Diseases Classified Elsewhere
- What is being tested?
- flap
- Type of treatment
- Surgery or procedure
- How many people
- 16 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Apr 2013to 1 Aug 2017
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: all the involved patients were edentulous in the maxillary posterior area , bilaterally, with a residual bone heigh of less then 4 mm; for this reason they required a surgical bone reconstruction for implant placement.
Who may be able to join
- patient edentulous in the maxillary posterior area on both left and right side
- 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
2 sites in 1 country.
Italy2 sites
Siena University, Department of Periodontology, Policlinico Le Scotte Siena.
Siena, 53100
Tuscan School of Dentistry
Siena, 53100
About this study
Official title: Influence of Two Different Flap Designs for Sinus Floor Elevation. A Split-mouth Randomised Controlled Clinical Trial
It is assumed that the reduction of the flap dimension could provide a reduction of surgical time, post surgical complications and patient's discomfort when compared with the traditional surgical approach.
Read the detailed description
16 edentulous patients in maxillary posterior area were treated with a bilateral sinus lift procedure. Once enrolled in the study impressions were realised and the radiographic stent prepared, with radio-opaque references fixed in the positions where the implants should be inserted. Pre-surgical CT scan was executed after placing the stent in its proper position in patient's mouth. If no surgical contra-indications were detected at CT evaluation, patients were involved in the study.
- Being tested
- flap
- Keywords
- lateral approach, bone augmentation, sinus lift, flap
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
flapProcedure or surgery
Also called surgical approach, Sinus augmentation
after flap incision , the sinus cavity was opened and then the membrane raised up
| Study group | Role | What they receive |
|---|---|---|
| test side ( horizontal flap) | Horizontal incision was realised in alveolar mucosa, in order to obtain the exposure of the lateral wall of the maxillary sinus, thus accessing the sinus cavity Receives: Procedure: flap | |
| control side ( standard flap) | Trapezoidal flap was realised, using a crestal incision and two deep vertical incisions extended in the fornix to expose the lateral wall of the maxillary sinus Receives: Procedure: flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
height of augmented bone obtained
the height of the gained bone was recorded by using the control CT scan, realized after 6 months of follow up
Measured: 6 months
Secondary outcomes (2)
Duration of the surgery
both total and partial times of different surgical steps were recorded
Measured: 1 day
Post surgical patient's discomfort
all patients were asked to fill out a VAS scale, graduated from 1 (minimal pain ) to 10 ( maximum pain)
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 posted5 Sep 2017
- Study start1 Apr 2013
- Primary completion1 Aug 2017
- Study completion1 Aug 2017
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
- 16 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
- marco ferrari, clinical director, Study chair, tuscan school of dental medicine, university of Firenze and Siena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03272100
- Sponsor's protocol ID
- MSL001
- Status last verified
- Sep 2017
- First submitted
- 24 Aug 2017
- Last updated
- 5 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Two Different Flap Designs for Sinus Floor Elevation. A Split-mouth Randomised Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03272100
- Acronym / sponsor ID
- MSL001
- Keywords
- lateral approach, bone augmentation, sinus lift, flap
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of Firenze and Siena, Napoli, ItalyUniversity, hospital or other
- Study start
- 1 Apr 2013 (actual)
- Primary completion
- 1 Aug 2017 (actual)
- Study completion
- 1 Aug 2017 (actual)
- First posted
- 5 Sep 2017 (actual)
- 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 reduction of the flap dimension could provide a reduction of surgical time, post surgical complications and patient's discomfort when compared with the traditional surgical approach.
Detailed description
16 edentulous patients in maxillary posterior area were treated with a bilateral sinus lift procedure. Once enrolled in the study impressions were realised and the radiographic stent prepared, with radio-opaque references fixed in the positions where the implants should be inserted. Pre-surgical CT scan was executed after placing the stent in its proper position in patient's mouth. If no surgical contra-indications were detected at CT evaluation, patients were involved in the study.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| test side ( horizontal flap) | – | Procedure: flapHorizontal incision was realised in alveolar mucosa, in order to obtain the exposure of the lateral wall of the maxillary sinus, thus accessing the sinus cavity |
| control side ( standard flap) | – | Procedure: flapTrapezoidal flap was realised, using a crestal incision and two deep vertical incisions extended in the fornix to expose the lateral wall of the maxillary sinus |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- all the involved patients were edentulous in the maxillary posterior area , bilaterally, with a residual bone heigh of less then 4 mm; for this reason they required a surgical bone reconstruction for implant placement.
Key inclusion criteria (2 listed)
- patient edentulous in the maxillary posterior area on both left and right side
- 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| flapAlso: surgical approach, Sinus augmentationafter flap incision , the sinus cavity was opened and then the membrane raised up | Procedure or surgery | control side ( standard flap), test side ( horizontal flap) |
Primary outcome
height of augmented bone obtained
Time frame: 6 months
the height of the gained bone was recorded by using the control CT scan, realized after 6 months of follow up
2 secondary outcomes
Duration of the surgery
Time frame: 1 day
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 5 Sep 2017.
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, clinical director study chair
tuscan school of dental medicine, university of Firenze and Siena
2 sites 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 2 sites 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 5 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 obtained (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 5 Sep 2017.