Maxillary DeficiencySINUSLID_2023NCT06222970
Maxillary Sinus Augmentation Via the "Bone Lid Technique"
An observational study of Maxillary Deficiency, run by University of Pisa at 1 site in Italy.
Trial summary
Maxillary sinus augmentation is one of the most performed procedures to increase the bone quantity of the atrophic maxilla in order to allow implant placement. The aim of the present case series was to describe a surgical protocol to perform maxillary sinus augmentation with the "bone lid technique", and its outcomes… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Maxillary Deficiency
- What is being tested?
- Bone lid repositioning in course of sinus lift
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 4 May 2020to Dec 2024
- How long will I take part?
- 6 Months
- 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
- Adult, Older adult
Study population: patients referred to the Unit of Dentistry and Oral Surgery, University Hospital of Pisa, with a severe bone atrophy of the maxillary posterior areas that required bone grafting through a lateral approach of the maxillary sinus
Who may be able to join
- Partially or fully edentulous patients requiring an implant-prosthetic rehabilitation of the premolar or molar maxillary areas with a residual ridge height lower than 4 mm.
- Patients needing for a unilateral or bilateral sinus lift with a lateral wall approach.
Who cannot join
- Patients under treatment with immunosuppressive agents
- Patients under treatment with medications that could impair bone metabolism.
- Patients pregnant or breastfeeding.
- Patients who had received irradiation treatment to the head and neck area.
- Patients with uncontrolled diabetes.
- Patients with uncontrolled periodontal disease.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
U.O. Odontostomatologia e Chirurgia del Cavo Orale
Pisa, 56126
Antonio Barone, Professor, 050993327, antonio.barone@unipi.it
About this study
Maxillary sinus augmentation is one of the most performed procedures to increase the bone quantity of the atrophic maxilla in order to allow implant placement. The aim of the present case series was to describe a surgical protocol to perform maxillary sinus augmentation with the "bone lid technique", and its outcomes in a cohort of patients eligible for the procedure.
- Conditions
- Maxillary Deficiency
- Being tested
- Bone lid repositioning in course of sinus lift
- Medical subject headings
- Retrognathia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone lid repositioning in course of sinus liftProcedure or surgery
A full-thickness flap was elevated to access the lateral maxillary bone wall. Subsequently, a lateral access window was prepared using a piezoelectric device with specific bone tips, delimitating a trapezoidal bone lid.
Once the antrostomy was completed, the bone lid was gently removed with a Lucas surgical curette and anatomical tweezers, with great care to avoid damages to the Schneiderian membrane. The Schneiderian membrane was detached from the bone layer using specific sinus curettes. In case of sinus membrane perforation, the membrane was raised in all directions. All clinical cases received a cortical bone lamina to avoid graft particles displacement in the maxillary sinus. The elevated space was filled with chips of cortico-spongious bone. The antrostomy was then covered with the bone lid (osteotomy window), previously removed and preserved in physiological solution and fixed in the original anatomical position with a surgical glue. The flap was then repositioned and sutured.
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone gain
Measurement of bone height and width
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start4 May 2020
- Primary completion18 Sep 2023
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maxillary DeficiencyStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- University of Pisa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Barone, University of Pisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06222970
- Sponsor's protocol ID
- SINUSLID_2023
- Acronym
- SINUSLID_2023
- Status last verified
- Jan 2024
- First submitted
- 15 Jan 2024
- Last updated
- 30 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: data will be published after anonymization and/or as aggregated data
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maxillary Sinus Augmentation Via the "Bone Lid Technique"
- ClinicalTrials.gov ID
- NCT06222970
- Acronym / sponsor ID
- SINUSLID_2023 / SINUSLID_2023
- Conditions
- Maxillary Deficiency
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of PisaUniversity, hospital or other
- Study start
- 4 May 2020 (actual)
- Primary completion
- 18 Sep 2023 (actual)
- Study completion
- Dec 2024 (estimated)
- First posted
- 25 Jan 2024 (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.
Maxillary sinus augmentation is one of the most performed procedures to increase the bone quantity of the atrophic maxilla in order to allow implant placement. The aim of the present case series was to describe a surgical protocol to perform maxillary sinus augmentation with the "bone lid technique", and its outcomes in a cohort of patients eligible for the procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients referred to the Unit of Dentistry and Oral Surgery, University Hospital of Pisa, with a severe bone atrophy of the maxillary posterior areas that required bone grafting through a lateral approach of the maxillary sinus
Key inclusion criteria (2 listed)
- Partially or fully edentulous patients requiring an implant-prosthetic rehabilitation of the premolar or molar maxillary areas with a residual ridge height lower than 4 mm.
- Patients needing for a unilateral or bilateral sinus lift with a lateral wall approach.
Key exclusion criteria (6 listed)
- Patients under treatment with immunosuppressive agents
- Patients under treatment with medications that could impair bone metabolism.
- Patients pregnant or breastfeeding.
- Patients who had received irradiation treatment to the head and neck area.
- Patients with uncontrolled diabetes.
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 |
|---|---|---|
| Bone lid repositioning in course of sinus liftA full-thickness flap was elevated to access the lateral maxillary bone wall. Subsequently, a lateral access window was prepared using a piezoelectric device with specific bone tips, delimitating a trapezoidal bone lid. Once the antrostomy was completed, the bone lid was gently removed with a Lucas surgical curette and anatomical tweezers, with great care to avoid damages to the Schneiderian membrane. The Schneiderian membrane was detached from the bone layer using specific sinus curettes. In case of sinus membrane perforation, the membrane was raised in all directions. All clinical cases received a cortical bone lamina to avoid graft particles displacement in the maxillary sinus. The elevated space was filled with chips of cortico-spongious bone. The antrostomy was then covered with the bone lid (osteotomy window), previously removed and preserved in physiological solution and fixed in the original anatomical position with a surgical glue. The flap was then repositioned and sutured. | Procedure or surgery | – |
Primary outcome
Bone gain
Time frame: 6 months
Measurement of bone height and width
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Individual participant dataSharing planned: No. data will be published after anonymization and/or as aggregated data
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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.
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 Maxillary Deficiency, run by University of Pisa 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 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 30 Jan 2024. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone gain (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 30 Jan 2024; AzTrials last refreshed its copy on 27 Oct 2026.