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Effect of Buccal Fat Pad and Platelet Rich Fibrin After Ultrasonic Hydrodynamic Maxillary Sinus Membrane Elevation

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ClinicalTrials.gov Identifier: NCT04123860
Recruitment Status : Not yet recruiting
First Posted : October 11, 2019
Last Update Posted : October 11, 2019
Sponsor:
Information provided by (Responsible Party):
mostafa elmasry, Cairo University

Brief 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. 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


Condition or disease Intervention/treatment Phase
Maxillary Sinus Other: ultrasonic hydrodynamic maxillary sinus lift buccal pad fat Other: ultrasonic hydrodynamic maxillary sinus lift platelet rich fibrin Phase 4

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: it is randomized clinical trail
Masking: Single (Participant)
Masking Description: double
Primary Purpose: Treatment
Official Title: Comparative Study Between Effect of Buccal Fat Pad and Platelet Rich Fibrin After Ultrasonic Hydrodynamic Maxillary Sinus Membrane Elevation
Estimated Study Start Date : November 10, 2019
Estimated Primary Completion Date : December 10, 2020
Estimated Study Completion Date : December 10, 2021

Arm Intervention/treatment
Experimental: buccal fat pad
will undergo sinus lifting using intralift technique then placement of buccal fat pad followed by immediate implant placement.
Other: ultrasonic hydrodynamic maxillary sinus lift buccal pad fat
ultrasonic hydrodynamic maxillary sinus lift and buccal fat pad as grafting material followed by immediate implant
Other Name: intralift technique maxillary sinus lift

Active Comparator: prf
will undergo sinus lifting using intralift technique the prpration of PRF and immediate implant placement.
Other: ultrasonic hydrodynamic maxillary sinus lift platelet rich fibrin
ultrasonic hydrodynamic maxillary sinus lift and platelet rich fibrin as grafting material followed by immediate implant
Other Name: intralift technique maxillary sinus lift




Primary Outcome Measures :
  1. bone height gain [ Time Frame: 6 month ]
    amount of bone gain


Secondary Outcome Measures :
  1. bone density [ Time Frame: 6 month ]
    change in bone density



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • edentulous maxilla in premolar-molar areas with a residual ridge height of 5-9mm.

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04123860


Contacts
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Contact: Mostafa Ah El Masry, msc 00201221953838 mostafa.elmasry@hotmail.com

Sponsors and Collaborators
Cairo University
Investigators
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Study Chair: Mohamed Sa El Hadidy, phd Cairo University
Study Chair: Basma Ga Mousa, phd Cairo University
Study Chair: Alaa Sh Emara, phd Cairo University

Publications:
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Responsible Party: mostafa elmasry, teaching assistant, Cairo University
ClinicalTrials.gov Identifier: NCT04123860     History of Changes
Other Study ID Numbers: oral surgery 14
First Posted: October 11, 2019    Key Record Dates
Last Update Posted: October 11, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: i will check with my study chair

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by mostafa elmasry, Cairo University:
intralift
maxillery sinus lift
hydrodynamic ultrasonic
buccal pad fat
platelet rich fibrin
immediate dental implant