Retrieval of Displaced Root in the Maxillary Sinus Via Lateral Bony Window Using the Piezoelectric Device

November 25, 2023 updated by: mona samy sheta, Tanta University

Lecturer of Oral &Maxillofacial Surgery

Ten patients with displaced root in maxillary sinus will be included in this study. the root will be recieved via lateral bony window in maxillary sinus wall using peizoelectric device then the bony window will be repositioned in its place.The patients will be received, clinically and radiologically examined, managed and followed up at the Oral and Maxillofacial surgery Department, Faculty of Dentistry, Tanta University

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Purpose: This study is designed to allow removal of displaced root from maxillary sinus with minimal surgical injury and simultaneous preservation of the integrity of the lateral wall of maxillary sinus by repositioning of osteotomized lateral bony window.

Materials & Methods: Ten patients with displaced root in maxillary sinus will be included in this study.

surgical procedure: A full thickness flap will be elevated to expose the lateral wall of the sinus and a rectangular bony window will be done, then the sinus lining will be incised, the displaced root will be delivered, the bony window will be repositioned, and the flap will be sutured.

Preoperative evaluation: The patients will be evaluated clinically for presence of inflammation, infection or oroantral communication and radiographically using computed tomography (CT) scan to identify the position of the displaced root.

Postoperative evaluation: The patients will be evaluated clinically each week for one month regarding to healing, presence of infection, inflammation. Radiographically, immediate panoramic view to evaluate the position of bony window and four months later to evaluate bone healing CT scan.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Egypt
      • Tanta, Egypt, 3111
        • faculty of dentistry, Tanta university

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

root displaced in maxillary sinus absence of infection

Exclusion Criteria:

  • • patients taking medications that affect bone healing
  • patients underwent head and neck radiotherapy

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: lateral bony window in maxillary sinus
a displaced root in maxillary sinus which will be removed through a rectangular bony window will be done on the lateral wall of sinus using piezo-electric device after elevation of a full thickness mucoperiosteal flap, then the bony window will be repositioned, and the flap will be sutured.
Device: lateral bony window
bony window will be made on lateral maxillary sinus wall using piezo-electric device after elevation of full thickness mucoperiosteal membrane

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1. degree of pain evaluated clinically
Time Frame: one-two weeks
using visual analogue scale:0 represent no pain and 10 represents the highest level of pain
one-two weeks
soft tissue healing evaluated clinically
Time Frame: one- two week
presence of dehiscence and exposure of bone or not
one- two week
the position of bony window evaluated radiographically
Time Frame: one week
using panoramic view to evaluate the precise position of bony window
one week
bony window osteointegration and density evaluated radiographically
Time Frame: four months
CT scan will be used using hounsfield units to evaluate density >1250 D1 850-1250 D2 350-850 D3 150-350 D4
four months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
inflammation clinically
Time Frame: one week
0 no inflammation 1-3 mild inflammation 4-7 moderate inflammation 8-10 sever inflammation 0 no inflammation 1-3 mild inflammation 4-7 moderate inflammation 8-10 sever inflammation 0 no inflammation 1-3 mild inflammation 4-7 moderate inflammation 8-10 sever inflammation
one week

Collaborators and Investigators

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

Sponsor

Tanta University

Investigators

  • Principal Investigator: marwa t Ibrahim, lecturer, Tanta University
  • Principal Investigator: mona s sheta, lecturer, Tanta University

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 (Actual)

September 28, 2022

Primary Completion (Actual)

July 21, 2023

Study Completion (Actual)

September 30, 2023

Study Registration Dates

First Submitted

September 19, 2023

First Submitted That Met QC Criteria

September 19, 2023

First Posted (Actual)

September 26, 2023

Study Record Updates

Last Update Posted (Actual)

November 28, 2023

Last Update Submitted That Met QC Criteria

November 25, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014 (U.S. NIH Grant/Contract)

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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