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

Maxillary Sinus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04123860
• Other study ID #: oral surgery 14
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: November 10, 2019
• Est. completion date: December 10, 2021

Study information

• Verified date: October 2019
• Source: Cairo University
• Contact: Mostafa Ah El Masry, msc
• Phone: 00201221953838
• Email: mostafa.elmasry[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 12
• Est. completion date: December 10, 2021
• Est. primary completion date: December 10, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Maxillary Sinus

Intervention

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
• ultrasonic hydrodynamic maxillary sinus lift platelet rich fibrin
ultrasonic hydrodynamic maxillary sinus lift and platelet rich fibrin as grafting material followed by immediate implant

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (5)

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. Review. — View Citation

Kumar 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. Review. — View Citation

Lo Giudice G, Iannello G, Terranova A, Lo Giudice R, Pantaleo G, Cicciù 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. — View Citation

Peñarrocha-Diago M, Peñarrocha-Diago M, Sanchez-Recio C, Peñarrocha-Oltra D, Romero-Millán 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. — View Citation

Velázquez-Cayón R, Romero-Ruiz MM, Torres-Lagares D, Pérez-Dorao B, Wainwright M, Abalos-Labruzzi C, Gutiérrez-Pérez 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bone height gain	amount of bone gain	6 month
Secondary	bone density	change in bone density	6 month