Back to resultsRetrieval of Displaced Root in the Maxillary Sinus Via Lateral Bony Window Using the Piezoelectric Device
Primary Purpose
Oroantral Fistula, Displaced Tooth
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
lateral bony window
Sponsored by
About this trial
This is an interventional treatment trial for Oroantral Fistula focused on measuring displaced root, maxillary sinus, lateral bony window, piezoelectric device
Eligibility Criteria
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
Sites / Locations
- Faculty of Dentistry, Tanta University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
lateral bony window in maxillary sinus
Arm Description
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.
Outcomes
Primary Outcome Measures
1. degree of pain evaluated clinically
using visual analogue scale:0 represent no pain and 10 represents the highest level of pain
soft tissue healing evaluated clinically
presence of dehiscence and exposure of bone or not
the position of bony window evaluated radiographically
using panoramic view to evaluate the precise position of bony window
bony window osteointegration and density evaluated radiographically
CT scan will be used using hounsfield units to evaluate density >1250 D1 850-1250 D2 350-850 D3 150-350 D4
Secondary Outcome Measures
inflammation clinically
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
Full Information
NCT ID
NCT06054204
First Posted
September 19, 2023
Last Updated
September 19, 2023
Sponsor
Tanta University
1. Study Identification
Unique Protocol Identification Number
NCT06054204
Brief Title
Retrieval of Displaced Root in the Maxillary Sinus Via Lateral Bony Window Using the Piezoelectric Device
Official Title
Lecturer of Oral &Maxillofacial Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 28, 2022 (Actual)
Primary Completion Date
July 21, 2023 (Actual)
Study Completion Date
September 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oroantral Fistula, Displaced Tooth
Keywords
displaced root, maxillary sinus, lateral bony window, piezoelectric device
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
single group assignment patients
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
lateral bony window in maxillary sinus
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
lateral bony window
Intervention Description
bony window will be made on lateral maxillary sinus wall using piezo-electric device after elevation of full thickness mucoperiosteal membrane
Primary Outcome Measure Information:
Title
1. degree of pain evaluated clinically
Description
using visual analogue scale:0 represent no pain and 10 represents the highest level of pain
Time Frame
one-two weeks
Title
soft tissue healing evaluated clinically
Description
presence of dehiscence and exposure of bone or not
Time Frame
one- two week
Title
the position of bony window evaluated radiographically
Description
using panoramic view to evaluate the precise position of bony window
Time Frame
one week
Title
bony window osteointegration and density evaluated radiographically
Description
CT scan will be used using hounsfield units to evaluate density >1250 D1 850-1250 D2 350-850 D3 150-350 D4
Time Frame
four months
Secondary Outcome Measure Information:
Title
inflammation clinically
Description
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
Time Frame
one week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
mona s sheta, lecturer
Organizational Affiliation
Tanta University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
marwa t Ibrahim, lecturer
Organizational Affiliation
Tanta University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Dentistry, Tanta University
City
Tanta
ZIP/Postal Code
3111
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Retrieval of Displaced Root in the Maxillary Sinus Via Lateral Bony Window Using the Piezoelectric Device
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