NCT03837275

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 minimised 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2019

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 12, 2019

Completed
17 days until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

February 12, 2019

Status Verified

February 1, 2019

Enrollment Period

1 year

First QC Date

February 8, 2019

Last Update Submit

February 8, 2019

Conditions

Keywords

intraliftmaxillery sinus lifthydrodynamic ultrasonic

Outcome Measures

Primary Outcomes (1)

  • gained bone height

    measured in millimeters by cone beam computed tomography

    3 month

Study Arms (2)

humsfe

EXPERIMENTAL

Sinus Floor Elevation Between Hydrodynamic Ultrasonic Maxillary Sinus Floor Elevation Technique (Intralift Technique)

Procedure: Sinus Floor Elevation Between Hydrodynamic Ultrasonic Maxillary Sinus Floor Elevation Technique

closed sinus lift

ACTIVE COMPARATOR

transcrestal maxilllary sinus floor elevation

Procedure: closed maxillary sinus lift

Interventions

Sinus Floor Elevation Between Hydrodynamic Ultrasonic Maxillary Sinus Floor Elevation Technique (Intralift Technique) and implant placement

Also known as: intralift technique
humsfe

transdcrestal sinus lift and immediate implant placment

Also known as: transcrestal sinus lift
closed sinus lift

Eligibility Criteria

Age18 Years - 70 Years
Sexall(Gender-based eligibility)
Gender Eligibility Detailspatients are eligible for implant placement older than 18 years old
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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: 22143696BACKGROUND
  • Barone A, Santini S, Sbordone L, Crespi R, Covani U. A clinical study of the outcomes and complications associated with maxillary sinus augmentation. Int J Oral Maxillofac Implants. 2006 Jan-Feb;21(1):81-5.

    PMID: 16519185BACKGROUND
  • Vercellotti T, Nevins ML, Kim DM, Nevins M, Wada K, Schenk RK, Fiorellini JP. Osseous response following resective therapy with piezosurgery. Int J Periodontics Restorative Dent. 2005 Dec;25(6):543-9.

    PMID: 16353529BACKGROUND
  • Chipaila N, Marini R, Sfasciotti GL, Cielo A, Bonanome L, Monaco A. Graftless sinus augmentation technique with contextual placement of implants: a case report. J Med Case Rep. 2014 Dec 17;8:437. doi: 10.1186/1752-1947-8-437.

    PMID: 25515949BACKGROUND
  • Llopet J, Montaudon M, Guillaud E, Ella B. Comparison of 2 crestal sinus floor lift techniques performed on human cadavers. Implant Dent. 2014 Oct;23(5):626-32. doi: 10.1097/ID.0000000000000143.

    PMID: 25192160BACKGROUND

Study Officials

  • Mohamed S 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 A El Masry, msc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
double ( participant- outcome assessor) single blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: it is randomized clinical trial.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
teaching assistant

Study Record Dates

First Submitted

February 8, 2019

First Posted

February 12, 2019

Study Start

March 1, 2019

Primary Completion

March 1, 2020

Study Completion

December 1, 2020

Last Updated

February 12, 2019

Record last verified: 2019-02