Dental ImplanthumsfeNCT03837275
Hydrodynamic Ultrasonic Maxillary Sinus Floor Elevation Technique Versus Closed Maxillary Sinus Floor Elevation.
A study testing Sinus Floor Elevation Between Hydrodynamic Ultrasonic Maxillary Sinus Floor Elevation Technique and closed maxillary sinus lift in people with Dental Implant, run by Cairo University.
Trial summary
Placing implants in the posterior maxillary area has the drawback of working with scarce, poor quality bone in a significant percentage of cases. Numerous advanced surgical techniques have been developed to overcome the difficulties associated with these limitations. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Implant
- What is being tested?
- Sinus Floor Elevation Between Hydrodynamic Ultrasonic Maxillary Sinus Floor Elevation Technique and closed maxillary sinus lift
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Mar 2019to Dec 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- -
- The following inclusion criteria will be established: (Llopet et al., 2014) Inclusion criteria: edentulous maxilla in premolar-molar areas with a residual ridge height of 9 mm or less.
Who cannot join
- Exclusion criteria: sinuses with septa in the operated area, polyps, sequelae of fistulas or fractures.
- Cases for current study will be selected free from local pathosis. Patients will be free from any systemic disease that could affect their reparative power.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparative Study of Sinus Floor Elevation Between Hydrodynamic Ultrasonic Maxillary Sinus Floor Elevation Technique (Intralift Technique) Versus Closed Maxillary Sinus Floor Elevation.
Placing implants in the posterior maxillary area has the drawback of working with scarce, poor quality bone in a significant percentage of cases. Numerous advanced surgical techniques have been developed to overcome the difficulties associated with these limitations. Subsequent to reports on the elevation of the maxillary sinus through the lateral approach, there were reports on the use of the crestal approach, which is less aggressive but requires a minimal amount of bone. Furthermore, it is more sensitive to operator technique, as the integrity of the sinus membrane is checked indirectly. The main advantage of this new technique, Intralift, is that it does not require a minimum amount of crestal bone (indeed, the smaller the width of the crestal bone, the better this technique is performed). The possibility of damage to the sinus membrane is minimised by using ultrasound based hydrodynamic pressure to lift it, while applying a very non-aggressive crestal approach. Conclusions: We believe that this technique is an advance in the search for less traumatic and aggressive techniques, which is the hallmark of current surgery.
Read the detailed description
An essential condition for success in dental implant treatment is the amount and quality of bone in the area on which we decide to place the implant after careful diagnosis and planning. The posterior area of the upper jaw has anatomical features that make it unique compared to other areas, mainly due to the presence of the maxillary sinus. After tooth loss there is progressive bone resorption, combined with sinus pneumatization and loss of bone height and quality, which greatly hinders the placement of dental implant.
Sinus lifting procedures are performed routinely to provide the required height of proper and stable bone tissue around the dental implants to be inserted. The surgical technique of maxillary sinus Schneiderian membrane (MSSM) lifting with immediate/simultaneous installation of dental implants, generally results in significant bone formation. The recently reported graftless MSSM elevation procedure and the subsequent augmentation of bone have greatly changed our perspective of bone neoformation potential. The blood clot formed under the lifted MSSM appears to be of critical importance in bone neoformation potential, precluding the need for exogenous graft materials In elevation with the rotary technique, the main intraoperative complication is perforation of Schneider's membrane, which is observed in between 10-35% of all such operations, and which usually occurs in the osteotomy drilling phase while preparing the window for access to the sinus With the purpose of reducing the risk of perforating Schneider's membrane, vestibule osteotomy using ultrasound has been proposed, as this reduces the risk of soft tissue damage and percentage membrane perforation to 7%. Some studies in the literature are preliminary descriptions of the technique, while others present isolated cases and others in turn report case series - no significant differences being observed between the two techniques The selective cutting is the result of the limited amplitude. At this amplitude, only mineralized tissue will be cut, because soft tissue requires frequencies of greater than 50 kHz. Therefore, the use of piezoelectric instruments will reduce the risk of nerve damage. The reduction of overheating is explained by the generation of a cavitation effect in the irrigation solution due to the mechanical micro-movements at a frequency of approximately 25-30 kHz. This also accounts for reduced bleeding, which means better surgical visibility and increased safety.
Perforation of the Schneiderian membrane doubles the risk for the incidence of sinusitis or infection. Therefore, it is of great importance that any perforation should be avoided. The use of the piezoelectric device reduces the frequency of membrane perforation among surgeons with limited experience. Specific tips can even decrease the risk of accidental or iatrogenic perforations.
- Conditions
- Dental Implant
- Being tested
- Sinus Floor Elevation Between Hydrodynamic Ultrasonic Maxillary Sinus Floor Elevation Technique, closed maxillary sinus lift
- Keywords
- intralift, maxillery sinus lift, hydrodynamic ultrasonic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sinus Floor Elevation Between Hydrodynamic Ultrasonic Maxillary Sinus Floor Elevation TechniqueProcedure or surgery
Also called intralift technique
Sinus Floor Elevation Between Hydrodynamic Ultrasonic Maxillary Sinus Floor Elevation Technique (Intralift Technique) and implant placement
closed maxillary sinus liftProcedure or surgery
Also called transcrestal sinus lift
transdcrestal sinus lift and immediate implant placment
| Study group | Role | What they receive |
|---|---|---|
| humsfe | Experimental | Sinus Floor Elevation Between Hydrodynamic Ultrasonic Maxillary Sinus Floor Elevation Technique (Intralift Technique) Receives: Procedure: Sinus Floor Elevation Between Hydrodynamic Ultrasonic Maxillary Sinus Floor Elevation Technique |
| closed sinus lift | Active comparator | transcrestal maxilllary sinus floor elevation Receives: Procedure: closed maxillary sinus lift |
What is being measured
The primary outcome is the main question the study is designed to answer.
gained bone height
measured in millimeters by cone beam computed tomography
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2019
- Study startMar 2019 (estimated)
- Primary completionMar 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Dental ImplantStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Model description
- it is randomized clinical trial.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mostafa elmasry, Cairo University
- Investigators
- Mohamed S El Hadidy, phd, Study chair, Cairo UniversityBasma Ga Mousa, phd, Study chair, Cairo UniversityAlaa Sh Emara, phd, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03837275
- Sponsor's protocol ID
- oral surgery 14285
- Acronym
- humsfe
- Status last verified
- Feb 2019
- First submitted
- 8 Feb 2019
- Last updated
- 12 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: I will check with my study chair
Publications
Velazquez-Cayon R, Romero-Ruiz MM, Torres-Lagares D, Perez-Dorao B, Wainwright M, Abalos-Labruzzi C, Gutierrez-Perez JL. Hydrodynamic ultrasonic maxillary sinus lift: review of a new technique and presentation of a clinical case. Med Oral Patol Oral Cir Bucal. 2012 Mar 1;17(2):e271-5. doi: 10.4317/medoral.17430.
PubMed 22143696Barone A, Santini S, Sbordone L, Crespi R, Covani U. A clinical study of the outcomes and complications associated with maxillary sinus augmentation. Int J Oral Maxillofac Implants. 2006 Jan-Feb;21(1):81-5.
PubMed 16519185Vercellotti T, Nevins ML, Kim DM, Nevins M, Wada K, Schenk RK, Fiorellini JP. Osseous response following resective therapy with piezosurgery. Int J Periodontics Restorative Dent. 2005 Dec;25(6):543-9.
PubMed 16353529Chipaila N, Marini R, Sfasciotti GL, Cielo A, Bonanome L, Monaco A. Graftless sinus augmentation technique with contextual placement of implants: a case report. J Med Case Rep. 2014 Dec 17;8:437. doi: 10.1186/1752-1947-8-437.
PubMed 25515949Llopet J, Montaudon M, Guillaud E, Ella B. Comparison of 2 crestal sinus floor lift techniques performed on human cadavers. Implant Dent. 2014 Oct;23(5):626-32. doi: 10.1097/ID.0000000000000143.
PubMed 25192160
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Sinus Floor Elevation Between Hydrodynamic Ultrasonic Maxillary Sinus Floor Elevation Technique (Intralift Technique) Versus Closed Maxillary Sinus Floor Elevation.
- ClinicalTrials.gov ID
- NCT03837275
- Acronym / sponsor ID
- humsfe / oral surgery 14285
- Conditions
- Dental Implant
- Keywords
- intralift, maxillery sinus lift, hydrodynamic ultrasonic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Mar 2019 (estimated)
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 12 Feb 2019 (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.
Placing implants in the posterior maxillary area has the drawback of working with scarce, poor quality bone in a significant percentage of cases. Numerous advanced surgical techniques have been developed to overcome the difficulties associated with these limitations. Subsequent to reports on the elevation of the maxillary sinus through the lateral approach, there were reports on the use of the crestal approach, which is less aggressive but requires a minimal amount of bone. Furthermore, it is more sensitive to operator technique, as the integrity of the sinus membrane is checked indirectly. The main advantage of this new technique, Intralift, is that it does not require a minimum amount of crestal bone (indeed, the smaller the width of the crestal bone, the better this technique is performed). The possibility of damage to the sinus membrane is minimised by using ultrasound based hydrodynamic pressure to lift it, while applying a very non-aggressive crestal approach. Conclusions: We believe that this technique is an advance in the search for less traumatic and aggressive techniques, which is the hallmark of current surgery.
Detailed description
An essential condition for success in dental implant treatment is the amount and quality of bone in the area on which we decide to place the implant after careful diagnosis and planning. The posterior area of the upper jaw has anatomical features that make it unique compared to other areas, mainly due to the presence of the maxillary sinus. After tooth loss there is progressive bone resorption, combined with sinus pneumatization and loss of bone height and quality, which greatly hinders the placement of dental implant.
Sinus lifting procedures are performed routinely to provide the required height of proper and stable bone tissue around the dental implants to be inserted. The surgical technique of maxillary sinus Schneiderian membrane (MSSM) lifting with immediate/simultaneous installation of dental implants, generally results in significant bone formation. The recently reported graftless MSSM elevation procedure and the subsequent augmentation of bone have greatly changed our perspective of bone neoformation potential. The blood clot formed under the lifted MSSM appears to be of critical importance in bone neoformation potential, precluding the need for exogenous graft materials In elevation with the rotary technique, the main intraoperative complication is perforation of Schneider's membrane, which is observed in between 10-35% of all such operations, and which usually occurs in the osteotomy drilling phase while preparing the window for access to the sinus With the purpose of reducing the risk of perforating Schneider's membrane, vestibule osteotomy using ultrasound has been proposed, as this reduces the risk of soft tissue damage and percentage membrane perforation to 7%. Some studies in the literature are preliminary descriptions of the technique, while others present isolated cases and others in turn report case series - no significant differences being observed between the two techniques The selective cutting is the result of the limited amplitude. At this amplitude, only mineralized tissue will be cut, because soft tissue requires frequencies of greater than 50 kHz. Therefore, the use of piezoelectric instruments will reduce the risk of nerve damage. The reduction of overheating is explained by the generation of a cavitation effect in the irrigation solution due to the mechanical micro-movements at a frequency of approximately 25-30 kHz. This also accounts for reduced bleeding, which means better surgical visibility and increased safety.
Perforation of the Schneiderian membrane doubles the risk for the incidence of sinusitis or infection. Therefore, it is of great importance that any perforation should be avoided. The use of the piezoelectric device reduces the frequency of membrane perforation among surgeons with limited experience. Specific tips can even decrease the risk of accidental or iatrogenic perforations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- it is randomized clinical trial.
| Arm | Type | Receives |
|---|---|---|
| humsfe | Experimental | Procedure: Sinus Floor Elevation Between Hydrodynamic Ultrasonic Maxillary Sinus Floor Elevation TechniqueSinus Floor Elevation Between Hydrodynamic Ultrasonic Maxillary Sinus Floor Elevation Technique (Intralift Technique) |
| closed sinus lift | Active comparator | Procedure: closed maxillary sinus lifttranscrestal maxilllary sinus floor elevation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- -
- The following inclusion criteria will be established: (Llopet et al., 2014) Inclusion criteria: edentulous maxilla in premolar-molar areas with a residual ridge height of 9 mm or less.
Key exclusion criteria (2 listed)
- Exclusion criteria: sinuses with septa in the operated area, polyps, sequelae of fistulas or fractures.
- Cases for current study will be selected free from local pathosis. Patients will be free from any systemic disease that could affect their reparative power.
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 |
|---|---|---|
| Sinus Floor Elevation Between Hydrodynamic Ultrasonic Maxillary Sinus Floor Elevation TechniqueAlso: intralift techniqueSinus Floor Elevation Between Hydrodynamic Ultrasonic Maxillary Sinus Floor Elevation Technique (Intralift Technique) and implant placement | Procedure or surgery | humsfe |
| closed maxillary sinus liftAlso: transcrestal sinus lifttransdcrestal sinus lift and immediate implant placment | Procedure or surgery | closed sinus lift |
Primary outcome
gained bone height
Time frame: 3 month
measured in millimeters by cone beam computed tomography
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2019.
- Background: PubMed 22143696Velazquez-Cayon R, Romero-Ruiz MM, Torres-Lagares D, Perez-Dorao B, Wainwright M, Abalos-Labruzzi C, Gutierrez-Perez JL. Hydrodynamic ultrasonic maxillary sinus lift: review of a new technique and presentation of a clinical case. Med Oral Patol Oral Cir Bucal. 2012 Mar 1;17(2):e271-5. doi: 10.4317/medoral.17430.
- Background: PubMed 16519185Barone A, Santini S, Sbordone L, Crespi R, Covani U. A clinical study of the outcomes and complications associated with maxillary sinus augmentation. Int J Oral Maxillofac Implants. 2006 Jan-Feb;21(1):81-5.
- Background: PubMed 16353529Vercellotti T, Nevins ML, Kim DM, Nevins M, Wada K, Schenk RK, Fiorellini JP. Osseous response following resective therapy with piezosurgery. Int J Periodontics Restorative Dent. 2005 Dec;25(6):543-9.
- Background: PubMed 25515949Chipaila N, Marini R, Sfasciotti GL, Cielo A, Bonanome L, Monaco A. Graftless sinus augmentation technique with contextual placement of implants: a case report. J Med Case Rep. 2014 Dec 17;8:437. doi: 10.1186/1752-1947-8-437.
- Background: PubMed 25192160Llopet J, Montaudon M, Guillaud E, Ella B. Comparison of 2 crestal sinus floor lift techniques performed on human cadavers. Implant Dent. 2014 Oct;23(5):626-32. doi: 10.1097/ID.0000000000000143.
- Individual participant dataSharing planned: Undecided. I will check with my study chair
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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.
Mohamed S El Hadidy, phd study chair
Cairo University
Basma Ga Mousa, phd study chair
Cairo University
Alaa Sh Emara, phd study chair
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Sinus Floor Elevation Between Hydrodynamic Ultrasonic Maxillary Sinus Floor Elevation Technique and closed maxillary sinus lift in people with Dental Implant, run by Cairo University.
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 2 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 12 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Mostafa A El Masry, msc (00201221953838, mostafa.elmasry@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gained bone height (time frame: 3 month). 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 NCT03837275, which also lists 5 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 12 Feb 2019.