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

Phase 4

• Conditions: Maxillary Sinus
• Interventions: Other: ultrasonic hydrodynamic maxillary sinus lift platelet rich fibrin; Other: ultrasonic hydrodynamic maxillary sinus lift buccal pad fat

• Registration Number: NCT04123860
• Lead Sponsor: 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

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 Timeline

• Status Verified: 2019-10
• Study First Submitted: 2019-10-10
• Study First Submitted QC: 2019-10-10
• Last Update Submitted: 2019-10-10
• Study First Posted: 2019-10-11
• Last Update Posted: 2019-10-11
• Study Start: 2019-11-10
• Primary Completion: 2020-12-10
• Study Completion: 2021-12-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
prf	ultrasonic hydrodynamic maxillary sinus lift platelet rich fibrin	will undergo sinus lifting using intralift technique the prpration of PRF and immediate implant placement.
buccal fat pad	ultrasonic hydrodynamic maxillary sinus lift buccal pad fat	will undergo sinus lifting using intralift technique then placement of buccal fat pad followed by immediate implant placement.

Primary Outcome Measures

Name	Time	Method
bone height gain	6 month	amount of bone gain

Secondary Outcome Measures

Name	Time	Method
bone density	6 month	change in bone density