Maxillary SinusPhase 4NCT04123860
Effect of Buccal Fat Pad and Platelet Rich Fibrin After Ultrasonic Hydrodynamic Maxillary Sinus Membrane Elevation
A Phase 4 study testing ultrasonic hydrodynamic maxillary sinus lift buccal pad fat and ultrasonic hydrodynamic maxillary sinus lift platelet rich fibrin in people with Maxillary Sinus, 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 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Maxillary Sinus
- What is being tested?
- ultrasonic hydrodynamic maxillary sinus lift buccal pad fat and ultrasonic hydrodynamic maxillary sinus lift platelet rich fibrin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 10 Nov 2019to 10 Dec 2021
- Phase
- Phase 4
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- edentulous maxilla in premolar-molar areas with a residual ridge height of 5-9mm.
Who cannot join
- 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 Between Effect of Buccal Fat Pad and Platelet Rich Fibrin After Ultrasonic Hydrodynamic Maxillary Sinus Membrane 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 minimized 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 The buccal fat pad appears at 3 months in utero and continuously grows until birth (9). It protrudes at the anterior border of the masseter muscle and extends to the parotid duct, where it rests on the buccopharyngeal fascia, which covers the buccinator muscle. There is little change in the volume of buccal fat during aging, and it is approximately 10 mL
PRF is a natural fibrin-based biomaterial prepared from an anticoagulant-free blood harvest without any artificial biochemical modification that allows obtaining fibrin membranes enriched with platelets and growth factors
Read the detailed description
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 minimized 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 The buccal fat pad appears at 3 months in utero and continuously grows until birth (9). It protrudes at the anterior border of the masseter muscle and extends to the parotid duct, where it rests on the buccopharyngeal fascia, which covers the buccinator muscle. There is little change in the volume of buccal fat during aging, and it is approximately 10 mL
PRF is a natural fibrin-based biomaterial prepared from an anticoagulant-free blood harvest without any artificial biochemical modification that allows obtaining fibrin membranes enriched with platelets and growth factors
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
- Conditions
- Maxillary Sinus
- Being tested
- ultrasonic hydrodynamic maxillary sinus lift buccal pad fat, ultrasonic hydrodynamic maxillary sinus lift platelet rich fibrin
- Keywords
- intralift, maxillery sinus lift, hydrodynamic ultrasonic, buccal pad fat, platelet rich fibrin, immediate dental implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasonic hydrodynamic maxillary sinus lift buccal pad fatOther
Also called intralift technique maxillary sinus lift
ultrasonic hydrodynamic maxillary sinus lift and buccal fat pad as grafting material followed by immediate implant
ultrasonic hydrodynamic maxillary sinus lift platelet rich fibrinOther
Also called intralift technique maxillary sinus lift
ultrasonic hydrodynamic maxillary sinus lift and platelet rich fibrin as grafting material followed by immediate implant
| Study group | Role | What they receive |
|---|---|---|
| buccal fat pad | Experimental | will undergo sinus lifting using intralift technique then placement of buccal fat pad followed by immediate implant placement. Receives: Other: ultrasonic hydrodynamic maxillary sinus lift buccal pad fat |
| prf | Active comparator | will undergo sinus lifting using intralift technique the prpration of PRF and immediate implant placement. Receives: Other: ultrasonic hydrodynamic maxillary sinus lift platelet rich fibrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
bone height gain
amount of bone gain
Measured: 6 month
Secondary outcomes (1)
bone density
change in bone density
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2019
- Study start10 Nov 2019 (estimated)
- Primary completion10 Dec 2020 (estimated)
- Study completion10 Dec 2021 (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 Maxillary SinusStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- it is randomized clinical trail
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 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 Sa 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
- NCT04123860
- Sponsor's protocol ID
- oral surgery 14
- Status last verified
- Oct 2019
- First submitted
- 10 Oct 2019
- Last updated
- 11 Oct 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
Kim MK, Han W, Kim SG. The use of the buccal fat pad flap for oral reconstruction. Maxillofac Plast Reconstr Surg. 2017 Feb 25;39(1):5. doi: 10.1186/s40902-017-0105-5. eCollection 2017 Dec.
PubMed 28286743Lo Giudice G, Iannello G, Terranova A, Lo Giudice R, Pantaleo G, Cicciu M. Transcrestal Sinus Lift Procedure Approaching Atrophic Maxillary Ridge: A 60-Month Clinical and Radiological Follow-Up Evaluation. Int J Dent. 2015;2015:261652. doi: 10.1155/2015/261652. Epub 2015 Sep 16.
PubMed 26451145Kumar KR, Genmorgan K, Abdul Rahman SM, Rajan MA, Kumar TA, Prasad VS. Role of plasma-rich fibrin in oral surgery. J Pharm Bioallied Sci. 2016 Oct;8(Suppl 1):S36-S38. doi: 10.4103/0975-7406.191963.
PubMed 27829743Velazquez-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 22143696Penarrocha-Diago M, Penarrocha-Diago M, Sanchez-Recio C, Penarrocha-Oltra D, Romero-Millan J. Osteotomy in direct sinus lift. A comparative study of the rotary technique and ultrasound. Med Oral Patol Oral Cir Bucal. 2012 May 1;17(3):e457-61. doi: 10.4317/medoral.17599.
PubMed 22143735
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Effect of Buccal Fat Pad and Platelet Rich Fibrin After Ultrasonic Hydrodynamic Maxillary Sinus Membrane Elevation
- ClinicalTrials.gov ID
- NCT04123860
- Acronym / sponsor ID
- oral surgery 14
- Conditions
- Maxillary Sinus
- Keywords
- intralift, maxillery sinus lift, hydrodynamic ultrasonic, buccal pad fat, platelet rich fibrin, immediate dental implant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Nov 2019 (estimated)
- Primary completion
- 10 Dec 2020 (estimated)
- Study completion
- 10 Dec 2021 (estimated)
- First posted
- 11 Oct 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 minimized 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 The buccal fat pad appears at 3 months in utero and continuously grows until birth (9). It protrudes at the anterior border of the masseter muscle and extends to the parotid duct, where it rests on the buccopharyngeal fascia, which covers the buccinator muscle. There is little change in the volume of buccal fat during aging, and it is approximately 10 mL
PRF is a natural fibrin-based biomaterial prepared from an anticoagulant-free blood harvest without any artificial biochemical modification that allows obtaining fibrin membranes enriched with platelets and growth factors
Detailed description
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 minimized 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 The buccal fat pad appears at 3 months in utero and continuously grows until birth (9). It protrudes at the anterior border of the masseter muscle and extends to the parotid duct, where it rests on the buccopharyngeal fascia, which covers the buccinator muscle. There is little change in the volume of buccal fat during aging, and it is approximately 10 mL
PRF is a natural fibrin-based biomaterial prepared from an anticoagulant-free blood harvest without any artificial biochemical modification that allows obtaining fibrin membranes enriched with platelets and growth factors
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- it is randomized clinical trail
| Arm | Type | Receives |
|---|---|---|
| buccal fat pad | Experimental | Other: ultrasonic hydrodynamic maxillary sinus lift buccal pad fatwill undergo sinus lifting using intralift technique then placement of buccal fat pad followed by immediate implant placement. |
| prf | Active comparator | Other: ultrasonic hydrodynamic maxillary sinus lift platelet rich fibrinwill undergo sinus lifting using intralift technique the prpration of PRF and immediate implant placement. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- edentulous maxilla in premolar-molar areas with a residual ridge height of 5-9mm.
Key exclusion criteria (2 listed)
- 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 |
|---|---|---|
| ultrasonic hydrodynamic maxillary sinus lift buccal pad fatAlso: intralift technique maxillary sinus liftultrasonic hydrodynamic maxillary sinus lift and buccal fat pad as grafting material followed by immediate implant | Other | buccal fat pad |
| ultrasonic hydrodynamic maxillary sinus lift platelet rich fibrinAlso: intralift technique maxillary sinus liftultrasonic hydrodynamic maxillary sinus lift and platelet rich fibrin as grafting material followed by immediate implant | Other | prf |
Primary outcome
bone height gain
Time frame: 6 month
amount of bone gain
1 secondary outcome
bone density
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2019.
- Background: PubMed 28286743Kim MK, Han W, Kim SG. The use of the buccal fat pad flap for oral reconstruction. Maxillofac Plast Reconstr Surg. 2017 Feb 25;39(1):5. doi: 10.1186/s40902-017-0105-5. eCollection 2017 Dec.
- Background: PubMed 26451145Lo Giudice G, Iannello G, Terranova A, Lo Giudice R, Pantaleo G, Cicciu M. Transcrestal Sinus Lift Procedure Approaching Atrophic Maxillary Ridge: A 60-Month Clinical and Radiological Follow-Up Evaluation. Int J Dent. 2015;2015:261652. doi: 10.1155/2015/261652. Epub 2015 Sep 16.
- Background: PubMed 27829743Kumar KR, Genmorgan K, Abdul Rahman SM, Rajan MA, Kumar TA, Prasad VS. Role of plasma-rich fibrin in oral surgery. J Pharm Bioallied Sci. 2016 Oct;8(Suppl 1):S36-S38. doi: 10.4103/0975-7406.191963.
- 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 22143735Penarrocha-Diago M, Penarrocha-Diago M, Sanchez-Recio C, Penarrocha-Oltra D, Romero-Millan J. Osteotomy in direct sinus lift. A comparative study of the rotary technique and ultrasound. Med Oral Patol Oral Cir Bucal. 2012 May 1;17(3):e457-61. doi: 10.4317/medoral.17599.
- 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 Sa 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 Phase 4 study testing ultrasonic hydrodynamic maxillary sinus lift buccal pad fat and ultrasonic hydrodynamic maxillary sinus lift platelet rich fibrin in people with Maxillary Sinus, 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 1 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 11 Oct 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Ah 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?
bone height gain (time frame: 6 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 NCT04123860, 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 11 Oct 2019.