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

NCT04123860 | Unknown Phase 4 DMC

• 1 other identifier: oral surgery 14
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

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

Conditions

Maxillary Sinus

Keywords

intralift; maxillery sinus lift; hydrodynamic ultrasonic; buccal pad fat; platelet rich fibrin; immediate dental implant

Outcome Measures

Primary Outcomes (1)

• bone height gain

  amount of bone gain

  6 month

Secondary Outcomes (1)

• bone density

  6 month

Study Arms (2)

buccal fat pad

EXPERIMENTAL

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

prf

ACTIVE COMPARATOR

will undergo sinus lifting using intralift technique the prpration of PRF and immediate implant placement.

Other: ultrasonic hydrodynamic maxillary sinus lift platelet rich fibrin

Interventions

ultrasonic hydrodynamic maxillary sinus lift buccal pad fat OTHER

ultrasonic hydrodynamic maxillary sinus lift and buccal fat pad as grafting material followed by immediate implant

Also known as: intralift technique maxillary sinus lift

buccal fat pad

ultrasonic hydrodynamic maxillary sinus lift platelet rich fibrin OTHER

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

Also known as: intralift technique maxillary sinus lift

prf

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Related 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.

  PMID: 28286743 BACKGROUND

• Lo 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.

  PMID: 26451145 BACKGROUND

• 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. doi: 10.4103/0975-7406.191963.

  PMID: 27829743 BACKGROUND

• 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.

  PMID: 22143696 BACKGROUND

• Penarrocha-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.

  PMID: 22143735 BACKGROUND

Study Officials

• Mohamed Sa El Hadidy, phd

  Cairo University

  STUDY CHAIR

• Basma Ga Mousa, phd

  Cairo University

  STUDY CHAIR

• Alaa Sh Emara, phd

  Cairo University

  STUDY CHAIR

Central Study Contacts

Mostafa Ah El Masry, msc

CONTACT

00201221953838; mostafa.elmasry@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: double
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: teaching assistant

Model Details: it is randomized clinical trail

Study Record Dates

• First Submitted: October 10, 2019
• First Posted: October 11, 2019
• Study Start: November 10, 2019
• Primary Completion: December 10, 2020
• Study Completion: December 10, 2021
• Last Updated: October 11, 2019

Record last verified: 2019-10