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

Oroantral Fistula Clinical Trial

Official title:

Lecturer of Oral &Maxillofacial Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06054204
• Other study ID #: 2014
• Status: Completed
• Phase: N/A
• Start date: September 28, 2022
• Est. completion date: September 30, 2023

Study information

• Verified date: November 2023
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 30, 2023
• Est. primary completion date: July 21, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Displaced Tooth
• Fistula

Intervention

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

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Tanta University	Tanta

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1. degree of pain evaluated clinically	using visual analogue scale:0 represent no pain and 10 represents the highest level of pain	one-two weeks
Primary	soft tissue healing evaluated clinically	presence of dehiscence and exposure of bone or not	one- two week
Primary	the position of bony window evaluated radiographically	using panoramic view to evaluate the precise position of bony window	one week
Primary	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	four months
Secondary	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	one week