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

October 10, 2019 updated by: mostafa elmasry, Cairo University

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

Study Overview

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 Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.
ultrasonic hydrodynamic maxillary sinus lift and buccal fat pad as grafting material followed by immediate implant
Other Names:
  • intralift technique maxillary sinus lift
Active Comparator: prf
will undergo sinus lifting using intralift technique the prpration of PRF and immediate implant placement.
ultrasonic hydrodynamic maxillary sinus lift and platelet rich fibrin as grafting material followed by immediate implant
Other Names:
  • intralift technique maxillary sinus lift

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
bone height gain
Time Frame: 6 month
amount of bone gain
6 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
bone density
Time Frame: 6 month
change in bone density
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 10, 2019

Primary Completion (Anticipated)

December 10, 2020

Study Completion (Anticipated)

December 10, 2021

Study Registration Dates

First Submitted

October 10, 2019

First Submitted That Met QC Criteria

October 10, 2019

First Posted (Actual)

October 11, 2019

Study Record Updates

Last Update Posted (Actual)

October 11, 2019

Last Update Submitted That Met QC Criteria

October 10, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

i will check with my study chair

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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